Celgene

Celgene Seattle, WA, USA
Nov 16, 2019
Full time
Req #: Location: Seattle, Washington, United States Job Category: Technical Development Work Location: 400 Dexter Ave N. 98109 Organization: Bioengineering Employee Status: Full-time Job Type: Regular The Potency Group is seeking a talented Scientist to lead projects that characterize the biological activity of autologous and allogenic cell therapies which are currently undergoing clinical trials, including CAR T cell products. The Scientist will lead a team of 1-3 individuals who are developing analytical methods that evaluate the biological activity ( e.g. metabolism, proliferation, and effector function) of novel cell therapies. The successful candidate will facilitate the identification of new functional characterization methods to develop and oversee the design, execution, and analyses of experiments that lead to the development of robust analytical methods. These methods will be used to further understanding of cell therapies, support development of the manufacturing processes, and/or QC release of the drug product. The successful candidate will have a strong background in Immunology or related field and will have experience in projects requiring close collaboration with other groups, such as discovery research, product sciences, process development, and QC. The Scientist will be passionate about developing novel medicines, thrive in an intellectually challenging environment, and enjoy collaborating with a team of likeminded Scientists. Qualifications and Education Requirements • PhD with 2-6 years of experience in the field of Immunology, Cancer Biology, or related field, preferably in an industry setting. • Expertise developing analytical methods that functional characterize T cells, such as their metabolism, proliferative capacity, and/or functional activity ( e.g. cytotoxicity, cytokine secretion, etc .) • Experience with cell culture, ELISAs or similar technology platforms ( e.g. MSD, Luminex, AlphaLISA, etc .), and flow cytometry. • Experienced with authoring and revising test methods, protocols, and technical reports. • Demonstrated experience leading teams and managing direct reports. Preferred Qualifications • Experience with fluorescence microscopy, live cell imaging and analysis ( i.e. IncuCyte), and/or image cytometry • Experience with molecular techniques, such as developing qPCR and next generation technologies such as NanoString, single cell RNA sequencing, and cellular indexing of transcriptomes and epitopes by sequencing (CITE-seq). • High dimensional data analysis ( e.g. CytoBank, viSNE, SPADE, CITRUS, etc .). • Experience with Design of Experiment (DoEs) using JMP or equivalent statistical software. • Proficiency with relative potency methods, 4-PL, robustness assessments, establishing system suitability criteria, critical reagent qualification procedures, analyst training, method transfers, and/or method qualification/validation. • Demonstrated experience qualifying, transferring, validating, performance trending, and/or lifecycle management of analytical methods. Specific Duties • Emphasis on hands-on leadership, mentorship of direct reports, and fostering a creative, collaborative, and accountable working environment. • Responsibility for the development of cell-based immunoassays and next-generation functional interrogation techniques. Proficiency with regulatory requirements, understanding of CMC strategy, awareness of industry trends, and advocate for new technologies. About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Seattle, WA, USA
Nov 16, 2019
Full time
Req #: Location: Seattle, Washington, United States Job Category: Technical Development Work Location: 400 Dexter Ave N. 98109 Organization: Bioengineering Employee Status: Full-time Job Type: Regular Job Summary CMC Data Steward is a key technical role in global MSAT that works across multiple functions in Cell Therapy Development and operations (CTDO) to develop a sustainable manufacturing data lake strategy within cell therapy manufacturing network and respond to/manage ongoing CMC data requests originating from a diverse stakeholder within CTDO, manufacturing network, regulatory, clinical, CMC and TCT product teams. A successful candidate in this role will not only provide timely response to the data requests but also develop data management systems and infrastructure to enable a sustainable approach to such requests. The candidate is expected to guide/influence our collective thinking on identifying the right data set to answer the specific scientific question at hand and also direct the teams to the appropriate level of data verification/integrity requirements suitable for intended purpose of the data use. The role is at the center of everything we do in CTDO including process control strategy, continuous process verification, correlative analysis, process improvements to ultimately further our product and process knowledge. As such this role requires an individual who is not only skilled at navigating the complex set of data sources in a multi-site/multi-node complex global supply chain essential for cell therapy commercialization, but also has a sound understanding of the manufacturing process parameters and product attributes. The Sr. Process Engineer will play a key role in product lifecycle management, including development, characterization, commercialization of Celgene's of cell therapy products. Primary Responsibilities Serve as a single point of contact for managing CMC data requests in CTDO for late stage/commercial products. Work with the drug product and vector MSAT teams to ensure access/availability of the manufacturing data in support of continuous verification programs Serve as the MSAT member of the Celgene's correlative analysis team to ensure team has the access to the needed manufacturing data, contribute to the process/product knowledge understanding through this effort and bring the insights back to the MSAT team to drive process life cycle management plan Collaborate with data stewards and other stakeholders in CTDO to share data management best practices across development and manufacturing, and drive design of data policies, standards and procedures. Develop and maintain metadata and controlled vocabulary business terms (definitions and business rules) and other artifacts associated with the control and data standardization of data assets; and ensure that they are properly reviewed and approved by the Data Owners. Implement, maintain and monitor data quality requirements and business rules for assigned data assets and data attributes. Work with internal and external manufacturing sites to ensure ongoing manufacturing data is captured in a standardized way across sites in a single global database Identify systems, tools needed to manage the data lake and work with internal and external IT experts to simplify manufacturing data access Support investigation teams to troubleshoot atypical observations/non-conformances by providing the necessary data and insights to help identify root cause Serve as a point person to provide historical manufacturing data sets needed to establish and comparability and qualification protocols Improve workflow and processes followed for managing data requests to continue to simply and improve lead time for such requests Define the necessary level of data integrity/verifications required based on intended use. Responsibilities of this role include using software tools and systems to collect data sets that support advanced analytics of cell therapy manufacturing data. Train end-users on the use and maintenance of data management tools and systems. Assist in the transfer of tools and analytical methods to other functional groups, as needed BASIC Qualifications B.S. or M.S in Chemical Engineering, Biochemical Engineering or equivalent with minimum of 6+ years relevant experience in biologic process/analytical development or commercial biologic manufacturing process support. Experience working with various IT systems/automation platforms. 3+ years of experience working in a GMP environment Demonstrated ability to effectively work in cross functional teams in a fast-paced environment Excellent problem-solving skills. Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab) Strong scientific and technical writing. Excellent verbal and written communication skills to be able to communicate with a diverse audience with variable level of technical understanding of the systems and manufacturing processes Knowledge of MES and LIMS systems Ability to write scripts, specifically in VBA, Python, SQL, R-script, or C# is preferred PREFERRED QUALIFICATIONS Experience in development and/or characterization of biologics and/or cell therapy manufacturing processes. Knowledge of cellular immunology a plus. Experience working with databases such as Oracle or SQL Manager is preferred. About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Washington, DC, USA
Nov 15, 2019
Full time
Req #: Location: Washington, District of Columbia, United States Job Category: Market Access Work Location: City 20001 Organization: Market Access/Pricing Employee Status: Full-time Job Type: Regular Other Locations: United States-North Carolina-Durham, United States-South Carolina-Charleston, United States-South Carolina-Greenville, United States-Virginia-Norfolk The CAR T Market Access Manager is responsible for executing and pulling through all CAR T Market Access reimbursement strategies within all identified CAR T accounts specific to the geography during all phases of account on-boarding and post on-boarding. This role will lead all CAR T Market Access activities for the respective geography/territory and will collaborate with a variety of internal partners and external customers. The following states will be included in the territory: D.C. MD, NC, SC, VA. Responsibilities will include, but are not limited to, the following: Exhibit a high degree of Market Access technical expertise within both payer and hospital systems Meet annual and ongoing performance reviews and competency assignments Work cross functionally within the CAR T Market Access Team with the CAR T Account Management Team, National and Regional Account Executives, CAR T Patient Operations, CAR T Patient Support Services, policy, and legal and compliance to ensure Market Access product objectives are met Support CAR T Account Managers daily activities to ensure access pull-through Support CART Account Managers with P&T adoption and meet with external executives as needed to ensure economic information is shared in a timely manner during the onboarding of accounts Aggressively drive access pull through within CAR T identified accounts by establishing access account management goals for cellular therapy portfolio, successfully assisting CAR T Account Managers with launching new products, establishing and managing effective key operational partnerships in line with the strategic guidance from the CAR T Market Access Management team Facilitate and drive patient pull through within accounts as needed Oversee and lead execution of distribution channels and ensure challenges are escalated and triaged accordingly within identified accounts Contribute to the development and execution of focused business plans that align with the corporate objectives for CAR T accounts Provide education to CAR T accounts regarding policy changes and impact Provide market place feedback in a timely manner to corporate management on customer business trends, competitive updates, and account issues and opportunities Deliver impactful presentations with external healthcare professionals on access and reimbursement related topics The individual is required to achieve all assigned goals while maintaining compliance with all Celgene standards. This position requires the ability to drive within their assigned territory by automobile (and in some territories to travel by airplane). Required Experience/Skills/Knowledge: BA/BS degree Prior sales and/or marketing within the biopharmaceutical industry Hematology/Oncology experience and/or experience with complex buy and bill therapies Prior hospital/IDN experience Buy and bill experience Thorough understanding of P&T processes within the hospital setting of care Thorough knowledge of coding and billing Knowledge of health insurance coverage and reimbursement, inclusive of private commercial coverage and Medicare coverage Knowledge of health economics Comprehensive knowledge of inpatient reimbursement Thorough knowledge of the healthcare industry sales and marketing Thorough understanding of US compliance laws and guidelines Ability to work successfully in a fast-paced environment with the need to manage constant change Ability to deal with ambiguity ready to change gears and plans quickly Ability to build relationships quickly and credibly Ability to interact and effectively partner with senior leadership across the organization Proven organizational skills with ability to problem solve and manage multiple urgent priorities in parallel Flexible, adaptable, and able to react to changing circumstances and priorities with high level of commitment and professionalism Ability to develop key strategies and execute them; Strong analytical, consulting, and business planning skills Excellent written and verbal communication skills Experience working with finances/budgets Excellent interpersonal skills to effectively work with many diverse customers Excellent presentation skills to engage and meet the needs of various audiences Proven success in new product launched Proficient skill-set working with PowerPoint and Excel. Ability to drive a car with a valid driver's license Ability to work independently and travel as needed (up to 50%) Preferred Experience/Skills/Knowledge: Master s degree 10+ years of sales experience and/or payer experience 5+ years of Oncology or hematology sales or complex, high cost buy and bill therapies or sales management, marketing, and/or commercial experience Prior account management experience in payer setting Experience in the Academic and community setting About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Phoenix, AZ, USA
Nov 15, 2019
Full time
Req #: Location: Phoenix, Arizona, United States Job Category: Facilities Work Location: 620 N. 51st Avenue 85043 Organization: Engineering Employee Status: Full-time Job Type: Regular Purpose and Scope of Position The Principal Electrical Engineer is responsible for acting as a technical resource to the engineering, maintenance and validation departments. The position shall also be responsible for improving plant efficiency, capacity, capability and modernization objectives including direct involvement with the development, design, layout, building, testing, troubleshooting, repairs, and improvement of all manufacturing equipment and plant utility systems. The position also assures that a sound strategy is in place for power distribution for all electrical users within the facility. The primary objective of this position is to assure all electrical feeds to the facility are properly designed, sized, and maintained in a proper manner. Also, to provide expertise to support the Engineering, Maintenance, and other functional departments with all electrical needs. Required Competencies: Knowledge, Skills, and Abilities Advanced knowledge of The National Electric Code, High voltage up to 460 volts, machine controls including Programmable Logic Controllers (PLC s), relay logic, motor controls (VFD s and servo), temperature and pressure controls including PID, thermocouples, RTD s and transducers and operator interfaces. Ability to read electrical schematics and ladder logic. Advanced proficiency in MS Project, MS Word, Excel, PowerPoint, SharePoint and AutoCAD. Strong knowledge of cGMP, OSHA, DEA, USP, and EP Ability to work independently for extended periods of time. Ability to work effectively in a team environment. Intermediate knowledge of analytical troubleshooting. Duties and Responsibilities Maintain all manufacturing equipment, plant utility systems, and the physical plant including the electrical distribution system. Implement solutions to improve efficiency and prevent equipment obsolescence. Included are capital improvement projects such as installing HVAC systems, upgrading the WFI system, rebuilding/upgrading filling and packaging equipment, and installing new manufacturing and support equipment. Responsible for the internal running of electrical projects. Accountable for project initiation, planning and for overseeing project execution, implementation, and closeout. Responsible for the creation/revision of engineering drawings and specifications. Ensure individual compliance with the DEA and FDA regulations, cGMP and applicable department programs, including training, documentation, standard operating procedures, and Celgene policies and procedures. Performs other tasks as assigned. Education and Experience Bachelor s degree required, preferably in Electrical Engineering. Advanced degree preferred. 7 years relevant work experience in a manufacturing setting required, preferably in a regulated or pharmaceutical environment Electrical Engineering P.E. and design engineering experience preferred. An equivalent combination of education, experience and training may substitute. Working Conditions The incumbent will be required to work on a computer for approximately 4 hours per day. The incumbent may be exposed to conditions where there is electrical equipment on the floor approximately 5 % of the time. The incumbent may be required to climb ladders, walk on the roof, walk around the exterior of the facility exist approximately 5 % or less of the time. The incumbent may be required to stand for extended periods of 4 hours up to 5 % of the time. The incumbent may be required to work at elevated heights The incumbent may be exposed to noise, gases, odors, and wet/slippery conditions. Requires the ability to concentrate during lengthy technical discussions. #LI-POST About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies. Associated topics: electrician, image processing, kv, lighting, plc, solar, stationary engineer, transmission, wind, wiring
Celgene Phoenix, AZ, USA
Nov 15, 2019
Full time
Req #: Location: Phoenix, Arizona, United States Job Category: Quality Work Location: 620 N. 51st Avenue 85043 Organization: Quality Control Shift: 3rd Shift_USA Employee Status: Full-time Job Type: Regular Purpose and Scope of Position The Associate Analyst, QC Microbiology, is responsible for routine and non-routine microbiological testing and environmental monitoring in support of sterile product manufacturing. The Associate Analyst is also responsible for peer review and support activities in the laboratory to ensure smooth laboratory operation in accordance with the organization s policies, procedures, and state, federal and local laws and ensure compliance with current Good Manufacturing Practices (cGMP), USP, EP, JP and other regulatory requirements at all times. Required Competencies: Knowledge, Skills, and Abilities Basic proficiency in MS Word, Outlook, and Excel programs. Basic experience with various microbiological testing and environmental monitoring techniques. Basic knowledge of electronic laboratory management systems. Strong attention to detail. Basic organizational skills. Basic knowledge of cGMP, USP, EP, FDA/PDA, OSHA and other regulatory guidance documents as relates to microbiological testing and environmental monitoring. Basic written and verbal communication skills. Ability to gown and maintain a sterile work environment. Ability to accurately and completely understand and follow SOP, test method and cGMP requirements; uses good judgement and follows procedures. Basic GMP documentation skills. Knowledge of laboratory safety practices. Ability to pair with mentors for guidance as well as to collaborate with peers on day-to-day tasks; cooperative and works well with a team. Willingness to learn and share knowledge. Communicates effectively with peers, management and cross-functionally across the site. Basic knowledge of laboratory and aseptic processes. Ability to work under regular supervision. Basic critical reasoning and decision-making skills. Ability to pass an initial full physical with annual monitoring. Ability to deal appropriately with regulatory agencies during regulatory and non-regulatory inspections. Duties and Responsibilities Performs routine laboratory and EM activities. Prepares schedules and sample labels. Performs tests such as (but not limited to) bioburden, Growth Promotion, incoming media/reagent QC, BI testing. Operates laboratory equipment used to provide sterile and depyrogenated materials. Read EM and testing plates and assess against alert and action levels as appropriate. Performs microbial isolation techniques, Gram stains and supports microbial identification process. Performs environmental monitoring activities in support of manufacturing. Collects utility samples for analysis. Maintain qualification status on aseptic gowning, etc. Demonstrates aseptic technique when performing a Microbiological Test or EM. Perform testing/monitoring activities associated with protocols or special projects as required. Executes scheduled testing and monitoring activities within the QC lab and manufacturing facility. Communicates appropriately with peers and Laboratory Management regarding scheduled duties. Uses tracking tools as appropriate (EM batch release, sample trackers, etc.) Administrative tasks. Communicate effectively with management regarding more complex issues. Participate in departmental training initiatives. Document training per procedural and cGMP requirements. Actively seeks out opportunities to learn from others within and outside the department. Assist other analysts, freely sharing knowledge and experience. Executes best practices in the laboratory Perform peer review of testing data. Review all data in accordance with applicable procedures and cGMP requirements. Ensure all testing is performed in a compliant matter. Complete all review in accordance with required timelines. Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required. Performs general laboratory duties as assigned. Education and Experience High school diploma or equivalent required. Bachelor s Degree, particularly in Microbiology or Science related field, preferred. 0-2 years of Related Experience GMP Aseptic Manufacturing and/or Laboratory/Clean Room Experience preferred. An equivalent combination of education / experience may substitute. Working Conditions The incumbent will be required to wear uniform/ PPE to work in a manufacturing, warehouse, or laboratory environment. The incumbent may be fully gowned for extended periods of time within a restrictive movement environment. This may include standing, bending, reaching, kneeling, etc. The incumbent will have to perform work in a controlled environment with strict glove and gown requirements. The incumbent will be required to maintain a safety alertness due to work around hazardous equipment and cytotoxic product. This position requires regular medical surveillance and may require incumbent to wear a respirator or gown. The incumbent must be able to distinguish colors and possess correctable vision to 20/20; annual eye exam is required. The incumbent may analyze data and work with spreadsheets and graphs on a daily basis. The incumbent may be working in a laboratory or manufacturing setting up to 6 hours per day. The incumbent must be able to lift/carry not more than 25 pounds. #LI-POST About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies. Associated topics: bacteria, biopharmaceutical, dietary, dietician, disease, drug development, healthcare, metabolism, nutrition, trauma
Celgene Phoenix, AZ, USA
Nov 15, 2019
Full time
Req #: Location: Phoenix, Arizona, United States Job Category: Quality Work Location: 620 N. 51st Avenue 85043 Organization: Quality Control Shift: 2nd Shift_USA Employee Status: Full-time Job Type: Regular Purpose and Scope of Position The Associate Analyst, QC Microbiology, is responsible for routine and non-routine microbiological testing and environmental monitoring in support of sterile product manufacturing. The Associate Analyst is also responsible for peer review and support activities in the laboratory to ensure smooth laboratory operation in accordance with the organization s policies, procedures, and state, federal and local laws and ensure compliance with current Good Manufacturing Practices (cGMP), USP, EP, JP and other regulatory requirements at all times. Required Competencies: Knowledge, Skills, and Abilities Basic proficiency in MS Word, Outlook, and Excel programs. Basic experience with various microbiological testing and environmental monitoring techniques. Basic knowledge of electronic laboratory management systems. Strong attention to detail. Basic organizational skills. Basic knowledge of cGMP, USP, EP, FDA/PDA, OSHA and other regulatory guidance documents as relates to microbiological testing and environmental monitoring. Basic written and verbal communication skills. Ability to gown and maintain a sterile work environment. Ability to accurately and completely understand and follow SOP, test method and cGMP requirements; uses good judgement and follows procedures. Basic GMP documentation skills. Knowledge of laboratory safety practices. Ability to pair with mentors for guidance as well as to collaborate with peers on day-to-day tasks; cooperative and works well with a team. Willingness to learn and share knowledge. Communicates effectively with peers, management and cross-functionally across the site. Basic knowledge of laboratory and aseptic processes. Ability to work under regular supervision. Basic critical reasoning and decision-making skills. Ability to pass an initial full physical with annual monitoring. Ability to deal appropriately with regulatory agencies during regulatory and non-regulatory inspections. Duties and Responsibilities Performs routine laboratory and EM activities. Prepares schedules and sample labels. Performs tests such as (but not limited to) bioburden, Growth Promotion, incoming media/reagent QC, BI testing. Operates laboratory equipment used to provide sterile and depyrogenated materials. Read EM and testing plates and assess against alert and action levels as appropriate. Performs microbial isolation techniques, Gram stains and supports microbial identification process. Performs environmental monitoring activities in support of manufacturing. Collects utility samples for analysis. Maintain qualification status on aseptic gowning, etc. Demonstrates aseptic technique when performing a Microbiological Test or EM. Perform testing/monitoring activities associated with protocols or special projects as required. Executes scheduled testing and monitoring activities within the QC lab and manufacturing facility. Communicates appropriately with peers and Laboratory Management regarding scheduled duties. Uses tracking tools as appropriate (EM batch release, sample trackers, etc.) Administrative tasks. Communicate effectively with management regarding more complex issues. Participate in departmental training initiatives Document training per procedural and cGMP requirements. Actively seeks out opportunities to learn from others within and outside the department. Assist other analysts, freely sharing knowledge and experience. Executes best practices in the laboratory Perform peer review of testing data Review all data in accordance with applicable procedures and cGMP requirements. Ensure all testing is performed in a compliant matter. Complete all review in accordance with required timelines. Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required. Performs general laboratory duties as assigned. Education and Experience High school diploma or equivalent required. Bachelor s Degree, particularly in Microbiology or Science related field, preferred. 0-2 years of Related Experience GMP Aseptic Manufacturing and/or Laboratory/Clean Room Experience preferred. An equivalent combination of education / experience may substitute. Working Conditions The incumbent will be required to wear uniform/ PPE to work in a manufacturing, warehouse, or laboratory environment. The incumbent may be fully gowned for extended periods of time within a restrictive movement environment. This may include standing, bending, reaching, kneeling, etc. The incumbent will have to perform work in a controlled environment with strict glove and gown requirements. The incumbent will be required to maintain a safety alertness due to work around hazardous equipment and cytotoxic product. This position requires regular medical surveillance and may require incumbent to wear a respirator or gown. The incumbent must be able to distinguish colors and possess correctable vision to 20/20; annual eye exam is required. The incumbent may analyze data and work with spreadsheets and graphs on a daily basis. The incumbent may be working in a laboratory or manufacturing setting up to 6 hours per day. The incumbent must be able to lift/carry not more than 25 pounds. About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies. Associated topics: bacteria, biopharmaceutical, cytometry, drug discovery, food scientist, health, industrial hygienist, microbiology, protein, vaccine
Celgene Bothell, WA, USA
Nov 14, 2019
Full time
Req #: Location: Bothell, Washington, United States Job Category: Quality Work Location: th Pl SE 98021 Organization: Quality Operations Employee Status: Full-time Job Type: Regular We are seeking a Sr. Specialist, Quality Deviation Investigator . This role is responsible for leading deviation investigations to ensure the written investigation report contains the technical merit and completeness according to regulatory expectations. This position will be responsible for operating cross-functionally, collecting necessary data and information associated with the manufacturing and laboratory deviations. This position will lead root cause analysis sessions with site SME's and determine the associated corrective action to prevent the deviation from recurring. This person will be a key player in the JuMP Quality Assurance team and a champion for quality priority principles and compliance within the JuMP organization. This position reports directly to the Quality Manager responsible for deviation investigation management. Job Responsibilities Responsible for the Quality Assurance GMP deviation investigation lead at JuMP, and ensuring adherence to applicable GMP regulations and Juno policies and procedures Provide consistent direction and ensure timely completion of deviation investigations to ensure on-going consistency for investigation reports that will stand alone during regulatory inspections. Develop a comprehensive understanding of the manufacturing processes followed for Juno products and the associated risk management control strategy developed to identify process risks and associated critical controls around the associate processing steps. Develop the necessary skills using the appropriate tool(s) and statistical application in risk management and Root Cause Analysis to enable the effective and timely close of deviation investigations. Provide consistent oversight and recommendation of quality product disposition according to the results of the investigation. Collaborate with stakeholders and management, and communicate investigation status to management as appropriate. Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of implemented GMP policies and quality management systems. Contribute to the development and execution of Juno's PLI and commercialization readiness plan at JuMP Develop individual goals and ensure the timely completion of all deliverables. Champion and foster a positive and successful collaborative quality culture, aligned with Juno's existing culture. Act as subject matter expert for QA oversight of GMP deviation investigations during regulatory inspections. Basic Qualifications and Education Requirements BS in relevant Science or Engineering discipline and 7+ years of experience in execution of deviation investigations. Experience in Quality Assurance function or technical Manufacturing Science and Technology (MSAT) role in a GMP manufacturing operation. GMP compliance and FDA/EMA regulations experience Preferred Qualifications MS Degree in Science or Engineering Background in Protein Biologics or Cell Therapy Manufacturing is required Demonstrated excellence in written and verbal communication Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships THINK BIG. BE BRAVE. DELIVER About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Berkeley Heights, NJ, USA
Nov 14, 2019
Full time
Req #: Location: Berkeley Heights, New Jersey, United States Job Category: Clinical Operations Work Location: 300 Connell Dr 07922 Organization: Biostatistics Employee Status: Full-time Job Type: Regular Responsibilities will include, but are not limited to, the following: Contribute to efficient study design, preparing statistical consideration sections and providing input into other protocol sections. Perform simulations for ED statistical innovative designs. Prepare statistical analysis plans including table shells. Analyze clinical trial data; work with programmers to provide tables, listings and graphs, including ad hoc validation. Maintain / upgrade home-grown ED Stats software with ED Bayesian Methods. Review, synthesize, interpret and report analysis results. Provide ad hoc data driven analyses. Provide statistical input for the preparation of final study reports and other required documents. Escalates issues to functional management as necessary. Makes recommendations or resolves technical, quality, and timeline issues. Skills/Knowledge Required: MS or Ph.D in Statistics. At least 2 years clinical drug development experience with a Master's degree; or no additional experience with a Ph.D. as a study statistician. 1 plus years statistical computing experience (e.g. SAS, R, or other statistical computing software) Knowledge of MS Office products (Word, Excel, PowerPoint) Demonstrated skill in statistical methodologies and data analysis, especially in Bayesian methods. Knowledge of clinical trial design concepts. Also knowledge of Bayesian innovative designs in ED Demonstrated ability to learn statistical regulatory requirements. Good interpersonal, communication, writing and organizational skills. Ability to work in a team environment with medical personnel, clinical monitors, data managers, programmers and medical writers. About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Summit, NJ, USA
Nov 14, 2019
Full time
Req #: Location: Summit, New Jersey, United States Job Category: Quality Work Location: 556 Morris Avenue 07901 Organization: Quality Control Employee Status: Full-time Job Type: Regular Purpose and Scope of Position The LIMS Specialist is responsible for the management of the LIMS (Laboratory Information Management System)/ eLN (electronic lab notebook) in support of the chemistry and microbiology CAR-T QC laboratories with minimum supervision. This includes, but is not limited to, maintaining, updating and troubleshooting all LIMS/eLN related issues and assisting with system updates and/or enhancements. Required Competencies: Knowledge, Skills, and Abilities Advanced knowledge of LabWare or related LIMS/eLN Advanced knowledge of LIMS basic coding and code reviews Advanced knowledge of validation and/or maintenance of laboratory information systems Knowledge of cGMP Regulations and how they apply to QC laboratories Knowledge of analytical/microbiological test methods and environmental monitoring programs Knowledge of controlled barcode label printing Knowledge of Crystal Report design Ability to perform ADHOC inquires Strong written and verbal communication skills Detail-oriented with expertise in problem solving; solid decision-making abilities Strong interpersonal skills Strong ability to work independently and compliantly Results driven Duties and Responsibilities System Management Execute, Create or revise computer system validation documents (i.e. UAT, URS, OQ, PQ, etc.) as applicable Support Business buildouts and changes in LIMS/eLN for the QC lab Support IT in the Administration of the LIMS/eLN program Manage Business change controls for LIMS/eLN changes System Support Provide operations support to end users of the LIMS/eLN program Manage change controls for LIMS/eLN changes Provide expertise in the execution of business processes using LIMS/eLN system Troubleshoot issues and solve problems with minimum guidance Assist with errors and troubleshooting Assist users with enhancements, URD and URs gathering Provide end user training and on-the-job training (OJT) for laboratory and production employees where required Participate in internal audit of the system and system documentation Assist management with investigations and deviations Create and maintain LIMS related SOPs Support site projects and goals where applicable to streamline testing Function as system superuser where applicable Guide QC end users on the development of system enhancements with user requirements and business drivers Master Data Management Maintain master data objects Guide QC personnel on creating masterdata sets Training Assist with the development, implementation and deployment of training Provide end user training and on-the-job training (OJT) for laboratory and production employees where required Performs other tasks as assigned. Education and Experience Bachelor's Degree required, preferable in Science Advanced Degree preferred 5-8 years of relevant work experience, preferable in a regulated environment. 3-5 years of LabWare or related LIMS experience Previous experience with validation and/or maintenance of laboratory information systems Previous experience in a GMP QC role a plus An equivalent combination of education and experience may substitute Working Conditions The incumbent will be expected to work flexible hours where needed including some weekends The incumbent will be working a laboratory setting up to six (6) hours per day. The incumbent will be working around biohazardous materials, including chemical agents, up to six (6) hours per day. #LI-POST About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Summit, NJ, USA
Nov 14, 2019
Full time
Req #: Location: Summit, New Jersey, United States Job Category: Research and Early Development Work Location: 556 Morris Avenue 07901 Organization: Pharmacokinetics Employee Status: Full-time Job Type: Regular Key Responsibilities include: Supervise and/or perform non-compartmental pharmacokinetic (PK) data analysis using WinNonlin and interpret PK data. Develop in-depth understanding of core project issues Plan, implement, interpret and report PK and PK/PD investigations in Phase I, II, III and IV studies Apply, interpret, and report innovative modeling approaches through meta-analysis of population PK and exposure-response data towards dose optimization and commercial benchmarking. Work with CROs to conduct meta-analysis and report PK/PD data to support internal development (go/no go) decisions and registration. Evaluate the relationship between exposure and pharmacodynamic (PD) properties for compounds from discovery to proof of activity, and to late stage Phase 3 development Help support PK and PK/PD strategies for compounds under drug development for global regulatory submission and represent as clinical pharmacology/modeling simulation lead in regulatory interactions Prepare, with supervision, the eCTD dossiers of sections 2.5, 2.7.1 and 2.7.2 for NDA submission Recommends solutions to project and study teams Organizes and aids departmental training Negotiates with other functional areas on project outcomes and deliverables to meet conflicting demands (time, cost, quality/ performance) Required Qualifications: Ph.D. in a relevant scientific discipline which includes pharmacokinetics with at least 8 years of work experience, preferred. Master's degree with at least 14 years work experience will also be considered. A minimum of 4 years of experience analyzing preclinical and clinical pharmacology studies. Basic understanding of the global drug dev. process and collaborations among multiple functions from discovery to commercialization. Basic knowledge of the drug development process, GLP and GCP. Hands-on experience in using modeling software (e.g. NONMEM, MONOLIX, Gastroplus) Knowledge and experience in PK/PD and pharmacometric applications in all phases of clinical dev. process, PK/PD data compilation and manipulation with scripting softwares such as SAS, R and/or Splus. Knowledge of drug disposition and clinical pharmacology characterization of drugs Advanced scientific writing skills to explain complexity with clarity Up-to-date with emerging literature and new scientific development Preferred Qualifications: Evidence of external impact through presentations, manuscripts are strongly preferred. About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Seattle, WA, USA
Nov 14, 2019
Full time
Req #: Location: Seattle, Washington, United States Job Category: Technical Development Work Location: 400 Dexter Ave N. 98109 Organization: Bioengineering Employee Status: Full-time Job Type: Regular The Potency Group is seeking a talented Scientist to lead projects that characterize the biological activity of autologous and allogenic cell therapies which are currently undergoing clinical trials, including CAR T cell products. The Scientist will lead a team of 1-3 individuals who are developing analytical methods that evaluate the biological activity ( e.g. metabolism, proliferation, and effector function) of novel cell therapies. The successful candidate will facilitate the identification of new functional characterization methods to develop and oversee the design, execution, and analyses of experiments that lead to the development of robust analytical methods. These methods will be used to further understanding of cell therapies, support development of the manufacturing processes, and/or QC release of the drug product. The successful candidate will have a strong background in Immunology or related field and will have experience in projects requiring close collaboration with other groups, such as discovery research, product sciences, process development, and QC. The Scientist will be passionate about developing novel medicines, thrive in an intellectually challenging environment, and enjoy collaborating with a team of likeminded Scientists. Qualifications and Education Requirements • PhD with 2-6 years of experience in the field of Immunology, Cancer Biology, or related field, preferably in an industry setting. • Expertise developing analytical methods that functional characterize T cells, such as their metabolism, proliferative capacity, and/or functional activity ( e.g. cytotoxicity, cytokine secretion, etc .) • Experience with cell culture, ELISAs or similar technology platforms ( e.g. MSD, Luminex, AlphaLISA, etc .), and flow cytometry. • Experienced with authoring and revising test methods, protocols, and technical reports. • Demonstrated experience leading teams and managing direct reports. Preferred Qualifications • Experience with fluorescence microscopy, live cell imaging and analysis ( i.e. IncuCyte), and/or image cytometry • Experience with molecular techniques, such as developing qPCR and next generation technologies such as NanoString, single cell RNA sequencing, and cellular indexing of transcriptomes and epitopes by sequencing (CITE-seq). • High dimensional data analysis ( e.g. CytoBank, viSNE, SPADE, CITRUS, etc .). • Experience with Design of Experiment (DoEs) using JMP or equivalent statistical software. • Proficiency with relative potency methods, 4-PL, robustness assessments, establishing system suitability criteria, critical reagent qualification procedures, analyst training, method transfers, and/or method qualification/validation. • Demonstrated experience qualifying, transferring, validating, performance trending, and/or lifecycle management of analytical methods. Specific Duties • Emphasis on hands-on leadership, mentorship of direct reports, and fostering a creative, collaborative, and accountable working environment. • Responsibility for the development of cell-based immunoassays and next-generation functional interrogation techniques. Proficiency with regulatory requirements, understanding of CMC strategy, awareness of industry trends, and advocate for new technologies. About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Berkeley Heights, NJ, USA
Nov 14, 2019
Full time
Req #: Location: Berkeley Heights, New Jersey, United States Job Category: Clinical Operations Work Location: 300 Connell Dr 07922 Organization: Biostatistics Employee Status: Full-time Job Type: Regular As our Principal Statistician you are responsible for providing statistical support to the study teams. Serves as primary biostatistician on multiple studies. Participates in the development of protocols and statistical analysis plans. Reviews CRFs, programming specifications, and data management plans. Performs statistical analysis, interprets statistical results, and participates in the preparation of clinical study reports. Oversees the work of CROs that are performing any of the above listed tasks. May travel up to 10%. Responsibilities and Duties: Participate in protocol development; Calculate sample sizes and/or perform power calculations for proposed studies as well as for alternative designs to evaluate the costs and timelines of various scenarios; Propose methods for statistical analysis and write the statistical sections of study protocols; Review and consult on CRF design and database edit checks; Review programming and analysis specifications; Prepare randomization schedules; Write statistical analysis plans and prepare table shells. Ensure that tables, listings, and figures address the objectives of the study; Perform statistical analyses of clinical data using SAS and other statistical software packages as necessary. Oversee the work of internal programmers and/or CROs that are performing statistical analyses of clinical data; Lead the study teams in the review, and discussion, of analysis plans; Interpret statistical results and present study findings to the teams, senior management, and in various external forums; Participate in organizing and writing results for primary publication; and Maintain project files that ensure adequate and clear documentation of statistical analyses. Other responsibilities as assigned. Quality Requirements: Play a key role in meeting cross-functional goals through commitment, quality standards, and a customer service orientation. Contribute to a work environment that fosters professionalism, mutual respect, teamwork, and collaboration. Knowledge, Skills, Abilities and Qualification Requirements: Master's degree or Ph.D. in statistics, biostatistics, mathematics, or related field; 8+ years of prior experience in a drug-development environment; Experience or training with a wide-range of skills including SAS programming and other relevant statistical software, statistical methodology and theories, and analysis; Excellent computer skills in the following programs: MS Word, PowerPoint, and Excel; Experience writing technical documents, reports, and presentations; Ability to manage multiple and diverse issues; Key Competencies: Professionalism and customer service orientation Communication skills - written and verbal Planning, organizing and multi-tasking Prioritizing and time management Problem assessment and problem solving Information gathering and information monitoring Attention to detail and accuracy Flexibility, adaptability and teamwork About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Summit, NJ, USA
Nov 14, 2019
Full time
Req #: Location: Summit, New Jersey, United States Job Category: Technical Development Work Location: 556 Morris Avenue 07901 Organization: Drug Substance Development Employee Status: Full-time Job Type: Regular This position is responsible for managing a kilo-lab scale facility for drug substance process development and scale-up activities, associated with production of GMP and non-GMP drug substances and intermediates. Responsibilities include: Serve as a key member of a dynamic, scientifically driven team dedicated to the discovery, development, and optimization of safe, scalable, and efficient chemical syntheses and processes for active pharmaceutical compounds. Lead and manage day-to-day operations of the Drug Substance Development kilo-lab facility, with responsibility for GMP and non-GMP processing activities. Ensure facility/equipment operations, setup, cleaning, maintenance, and calibration are completed as required and compliant with all relevant SOPs and regulations Manage all aspects of facility planning and scheduling Maintain and control inventory of raw materials, intermediates, retains, and finished APIs associated with the kilo lab facility Ensure that activities performed in the kilo lab facility meet all requirements for process safety and maintain compliance with all applicable safety and environmental standards and regulations. Oversee and maintain all quality systems for the kilo lab area (SOPs, training, documentation, etc.) to ensure cGMP compliance with standards and regulations. Develop and track performance metrics for kilo lab operations. Remaining current with required GMP training and qualifications. Apply cGMP principles by following internal standard operating procedures (SOPs), work practices (WPs), and regulatory requirements. Drive strategic plans for the kilo lab area, including operational enhancements, new equipment/capability purchase and installation, capacity expansion, etc.. Assist in development of appropriate business case justification. Manage annual and multi-year capital and expense planning and budgets for kilo lab area. Provide guidance and oversight to all chemist and engineering staff who utilize the kilo lab area, establishing and driving best practices for all unit operations and activities. Serve as a resource of scientific and technical expertise regarding scale-up and kilo-lab operations. Apply fundamental chemistry and engineering principles to solve challenges in process development moving from bench to kilo-lab. Integrate DSD kilo-lab systems and operations with partner areas, including Drug Product Development scale-up facility, Laboratory Systems Management, Facilities group, EHS, etc. Prepare technical reports, publications and oral presentations. Supervise DSD technical staff and/or kilo lab operations staff under a matrix organization. Enhance the scientific and business capabilities of the department. Skills/Knowledge Required : BS in Chemistry, Chemical Engineering, or a related field with relevant industry experience. MS/PhD preferred. Minimum of 10 yrs experience in the pharmaceutical industry in small molecule drug substance development and operations. Understanding and application of cGMPs and current regulatory standards in drug substance manufacturing for global clinical programs. Experience in pharmaceutical development as it relates to drug substance process development, scale-up, technology transfer and process safety. Proven track record in scale-up and implementation of innovative, safe, and effective processes for the manufacture of chemical intermediates and drug substances. Demonstrated record of implementing creative solutions to overcome synthetic and manufacturing obstacles. Demonstrated ability to balance technical needs, resource requirements, and other business considerations across multiple assigned projects. Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment. Ability to work with a sense of urgency, independently or in leading a team under deadline. Verbal and written communication skills are essential. Demonstrated proficientcy with standard and custom software programs / applications. Experience with broad CMC issues encountered in drug development, and experience with regulatory filings (IND/NDA) are highly desirable. Direct or indirect supervisory experience. Experience in operations involving highly potent compounds a plus. #LI-POST About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Summit, NJ, USA
Nov 14, 2019
Full time
Req #: Location: Summit, New Jersey, United States Job Category: Technical Development Work Location: 556 Morris Avenue 07901 Organization: Pharmaceutical Development Employee Status: Full-time Job Type: Regular Analytical Development Analytical Development is a science-driven organization dedicated to building in-depth and comprehensive knowledge of our products and their processes through well-designed analytical studies. We work in all phases of pharmaceutical development to oversee the analytical processes for drug substance and drug product development both internally and with external contract service providers. Our goal is to enable the establishment of specifications and robust analytical procedures that allow control of our drug substance and drug product processes to provide safe, efficacious and high quality products to the patients we serve. Responsibilities for a Principal Scientist will include, but are not limited to, the following: The Principal Scientist is responsible for the development and validation of analytical methodology for the characterization of our products and processes, the creation of fundamental product and process understanding, and the advancement of innovative approaches to drug development. Support for drug candidates across all stages of development and, as needed, within our commercial product portfolio will be required. The Principal Scientist works with minimal supervision to carry out laboratory based de novo analytical methods development, chemical characterization studies and chemical stability characterization evaluations. Where required, activities will be performed in accordance with cGLP/cGMP regulations, established business processes and protocols, and applicable standard operating procedures. The Principal Scientist will have organizational and interdepartmental responsibilities with regards to leading workgroups, cross-functional teams, strategy development/implementation/execution, and cultural initiatives. Support drug substance process development including characterization of starting materials, intermediates, and final API. Support drug product formulation and process development including characterization of the process and finished product. Develop, optimize and validate analytical methods. Support drug substance and drug product impurity characterization and identification. Qualify/transfer analytical methodology to quality control and contract laboratories. Provide leadership and supervision to scientific staff. Develop, coach and mentor others. Serve on and lead departmental, interdepartmental and project teams. Report and discuss analytical results and conclusions both orally and in writing. Write formal reports for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities. Represent the company in discussions with regulatory authorities and alliance partners Review analytical data for completeness and correctness. Complies with Environmental Health and Safety Requirements. Ensure that all facilities, equipment and personnel are and remain in compliance with cGLP / cGMP, FDA and EMA requirements, appropriate SOPs and corporate policies. Contributes to the ownership and advancement of lab instrumentation, work processes, and procedures. Skills/Knowledge in the following areas are required : BS/MS/PhD in Chemistry (or relevant discipline) with required years of experience Completed BS and minimum of 12 years; MS minimum of 10 years; or Ph.D. and minimum of 8 years in Chemistry (or relevant discipline) with pharmaceutical experience. Fluency in synthetic chemistry, drug substance processing, formulation development, pharmaceutical processing with a deep understanding of pharmaceutical sciences related to drug product development Mastery of chemistry with extensive expertise in measurement science. Experience in the development and performance of analytical tests for a variety of drug substances and products (including solid oral dosage forms and injectables). Knowledge of dissolution method development and testing, biopharmaceutical classification system, and IVIVC / IVIVR. Strong statistical knowledge and capabilities. Understands drug development and works to build CMC dossier for regulatory submissions as an author/reviewer. Advanced skills in DOE, Lean and/or Six Sigma. Familiar with modern laboratory equipment and automation. Understands and applies Quality by Design principles when required Advanced skills in PAT and chemometrics. Additional Expectations of the Principal Scientist include: Exceptional verbal and written communication skills and interpersonal skills as a team member/leader in an environment where individual initiative, collaboration and accountability are valued. A demonstrated record of scientific accomplishment, laboratory experimentation, publication and presentation. Beginning to impact not just AD but multiple departments. This impact is achieved through leading groups and contributing to cross-functional teams. An expert related to cGLP/cGMP and applicable FDA, EMA and ICH guidance. Mastery of USP and other compendia and how they guide drug development decisions. Strong problem-solving and troubleshooting skills. Strong capabilities in experimental design and execution. Works independently and is a leader in the department. Ability to provide scientific guidance, leadership, and training to others within the department. Ability to supervise others directly and is a scientific leader/mentor within department and in wider organization. An absolute commitment to and demonstrated proficiency in employee development. External visibility and connection with outside scientific, regulatory, and trade organizations relevant to Celgene operating model. May present and publish to influence policy outside of Celgene. About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Summit, NJ, USA
Nov 14, 2019
Full time
Req #: Location: Summit, New Jersey, United States Job Category: Technical Development Work Location: 556 Morris Avenue 07901 Organization: Chemistry Employee Status: Full-time Job Type: Regular Principal Scientist, Drug Substance Development Summit, NJ Responsibilities include: Serve as a key member of a dynamic, scientifically driven team dedicated to the discovery and development of elegant chemical syntheses and processes for active pharmaceutical compounds. Represent Drug Substance Development (DSD) on multidisciplinary Chemistry Manufacturing, and Controls (CMC) teams with direct scientific responsibility and oversight of DSD staff. Apply fundamental chemistry and engineering principles to solve challenges in synthesis and process development from bench through pilot plant manufacture. Develop and execute phase appropriate risk-based development and drug substance supply plans. Manufacture development candidates for pre-IND studies. Manage technology transfers to and support manufacturing of GMP Drug Substance (DS) at Contract Research Organizations. Conduct DS related due diligence assessments for potential external collaborations. Serve as Celgene DSD representative on external collaborations. Remaining current with required GMP training and qualifications. Apply cGMP principles by following internal standard operating procedures (SOPs), work practices (WPs), and regulatory requirements. Assist in the preparation of CMC regulatory documents. Evaluate and maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals. Serve as a resource of scientific and technical expertise. Supervise scientists under a project specific matrix organization. Prepare technical reports, publications and oral presentations. Enhance the scientific and business capabilities of the department. Skills/Knowledge Required : Ph.D. in Organic Chemistry with 8 + years relevant industrial experience. Excellent laboratory skills and knowledge of organic synthesis. Proficient in the use and interpretation of NMR, HPLC, MS, IR, DSC, TGA, XRD, and automation. Experience in pharmaceutical development as it relates to route selection, process development, salt selection, polymorphism, solubility, and stability testing. Proven track record in developing and scaling-up innovative, safe, and effective processes for the manufacture of chemical intermediates and drug substances. Demonstrated record of implementing creative solutions to overcome synthetic and manufacturing obstacles. Extensive patent and academic journal publication record a plus. Ability to balance scientific, legal, and business needs as they relate to a given project. Ability to balance multiple projects at different levels, must be able to concomitantly work effectively in the lab and as a project manager. Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary team environment. Ability to work independently or in team environments under deadlines. Excellent verbal skills are essential, must be able to contextualize complex issues for colleagues in and outside of the department. Solid writing skills are critical, must be able to succinctly capture technical and project related information from diverse sources. Experience with CMC issues encountered in drug development. Familiarity with GMP manufacturing and regulatory filings. Direct or indirect supervisory experience. #LI-POST About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Berkeley Heights, NJ, USA
Nov 14, 2019
Full time
Req #: Location: Berkeley Heights, New Jersey, United States Job Category: Clinical Operations Work Location: 300 Connell Dr 07922 Organization: Biostatistics Employee Status: Full-time Job Type: Regular Job Description: At Celgene Corporation, we're committed to changing the course of human health through bold pursuits in science, life-enhancing therapies and a promise to always put patients first. At the core of that mission are the talented individuals on our Biostatistics team who collaborate globally and cross-functionally to drive innovation. Join our team as a Director, Statistics - Real World Evidence and help us deliver truly innovative and life-changing medications to our patients worldwide. What great looks like in this Role: Our ideal Director, Statistics is responsible for leading initiating and overseeing statistical support for a growing area of Real-World Evidence trials in support of regulatory submissions and market access. If you're up for the challenge, apply today! Responsibilities of this Role: Requires managing multiple projects within Hematological Oncology and Solid Tumor Oncology indications Provides guidance and leadership in the appropriate design, management, analysis and reporting of RWE studies. Provide appropriate guidance to statisticians and programmers to ensure high quality and timely deliverables Manages resources, sets priorities, and ensures consistency and adherence to standards therein. Contributes to planning for submissions, and post-submission strategies, preparations and defenses. Contributes to creation/maintenance of, and provides training on statistical topics and departmental SOPs and WPs Seeks and responds to stakeholder feedback to increase efficiencies, synergies, and performance Represents Celgene at professional societies, and in industry-wide technical discussions. Is sought after as a trusted employee advocate and management coach by senior management regionally Resolves technical, quality, and timeline issues. Identifies external statistical experts for consultation Develops performance metrics for staff Provides guidance to employees' development plans and carries out performance review and feedback Manages a functional area and has authority to allocate company resources according to project needs Proactively builds partnerships with specialist functions and global counterparts to maximize knowledge and available resources Manages and coordinates limited resources to produce quality deliverables within timelines for competing priorities Ensures that flexible and rapid responses are provided for statistical requests Identifies and assists in the resolution of bottlenecks for study/project teams Participates in identifying strategies to optimize clinical trial design and in response to regulatory agencies' requests Represents the company in interfaces with regulatory agencies globally Serves as the statistical representative in the defense of the company position/approach on statistical issues and drug approvals globally Interacts and manages KOLs/CROs and represents the company in external scientific forums Develops and implements highly innovative solutions to solve complex corporate-wide problems Provides active coaching to biostatistical team members when developing solutions to problems. Manages team conflicts with external partners/customers Act as a resource/mentor to study team members - both internally and externally Shapes Biostatistics function to create and leverage programs, policies, and procedures to provide value added solutions for Biostatistics. Provides input into the long-term Biostatistics strategy and structure Assesses, provides direction, and resolves complex stakeholder concerns, providing direction to direct reports. Member of Management Staff. Provide Leadership Builds a professional and effective Statistical community that is seen as a business asset and attracts, develops and retains top talent Knowledge and Skills Required: Ph.D. in Statistics with 11+ years pharmaceutical experience in a pharmaceutical R&D environment OR MS in Statistics with 13+ years of related experience Strong knowledge of clinical trial design concepts, drug regulation, exploratory analyses for publication and experience in the management of the statistical function Knowledge of Real-World Evidence (RWE) methodology and experience with real world studies a decided advantage Excellent knowledge of SAS programming essential and knowledge of R a plus Demonstrated skill in the planning, analysis and reporting of clinical trials Detailed knowledge of statistical methodologies, particularly in propensity score modeling and other analyses of RWE Demonstrated ability to plan, organize, and prioritize multiple work assignments, and strong project management skills In-depth knowledge of all phases of the global drug development process Demonstrated ability to work in a team environment with clinical team members Good interpersonal, communication, writing and organizational skills Demonstrated skill in resource management Ability to research new statistical methods and ensure alignment with regulatory agencies and industry standards Demonstrated development of approaches to enhance the Workforce Planning and Talent Management strategy of the internal and external talent pools within a therapeutic area Demonstrated development of resourcing strategies and recruiting practices, working with senior leaders to define positions and organizational structure, and anticipating future requirements and specialty areas #LI-POST About Us At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies. About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Seattle, WA, USA
Nov 14, 2019
Full time
Req #: Location: Seattle, Washington, United States Job Category: Technical Development Work Location: 400 Dexter Ave N. 98109 Organization: Bioengineering Employee Status: Full-time Job Type: Regular Juno Therapeutics, a Celgene Company, is a clinical-stage company developing novel cellular immunotherapies based on two distinct and complementary platforms - Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body's immune system to treat cancer. We are looking for a Senior Scientist to lead the development of analytical methods of AAV vector in support of allogeneic CART programs. The ideal candidate has a proven track record of innovation, demonstrated skill set and knowledge in analytical development, and is excited to take on new challenges in a fast-paced and dynamic environment. This incumbent is responsible for overseeing development of AAV characterization and release assays at contract manufacturing organizations (CMOs) and contract test laboratories (CTLs) and coordinating the qualification and validation thereof. These analytical methods will be used to support QC release and in-process testing of AAV vector used for CART /TCR gene delivery. The incumbent will plan and coordinate execution of laboratory studies, analyze experimental data, document results, and present findings to CMC and Core teams. This position requires project leadership and management skills and attention to scientific detail. If you are dedicated to excellence and want to make a difference, we're excited to hear from you! Job Description: Coordinate development and qualification analytical methods to enable AAV process development, release and stability testing at CMOs/CTLs Lead the development of AAV control strategy; work with a cross-functional team to design and execute CMC development plan in support of allogeneic CART programs. Oversee the successful design, execution, interpretation, and documentation of experiments. Support AAV process development effort Contribute to development of novel technologies for gene and cell therapy. Author, review, and approve technical documents, including standard operating procedures, QC test methods, and analytical sampling plans. Contribution to regulatory submissions Summarize and present data in cross-functional team meetings Basic Qualifications: Ph.D. degree in virology, analytical sciences, or related field with 8+ years of experience in AAV analysis and/or drug development Knowledge and experience with AAV biology Demonstrated knowledge of control strategy and analytical development for CMC programs Demonstrated method development experience in techniques such as viral safety and potency assays, viral titer assays, quantitative PCR (qPCR), ELISA, etc. Demonstrated skillset in experimental design, data analysis, interpretation, and presentation. Proven ability to work in a fast-paced environment, meet deadlines, & prioritize work on multiple projects. Strong attention to detail with the ability to handle multiple responsibilities simultaneously Ability to work independently and as part of a team. Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment. Preferred Qualifications: Experience interfacing with contract manufacturing and research organizations, GMP contract test laboratories Demonstrated experience in cross-functional and functional leadership roles. Experience with gene engineering of T cells using viral modalities. Experience authoring technical and regulatory documents. Track record of successful internal and external scientific collaborations. About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Phoenix, AZ, USA
Nov 14, 2019
Full time
Req #: Location: Phoenix, Arizona, United StatesJob Category: QualityWork Location: 620 N. 51st Avenue 85043Organization: Quality ControlShift: 3rd Shift_USAEmployee Status: Full-timeJob Type: RegularPurpose and Scope of PositionThe Associate Analyst, QC Microbiology, is responsible for routine and non-routine microbiologicaltesting and environmental monitoring in support of sterile product manufacturing. The AssociateAnalyst is also responsible for peer review and support activities in the laboratory to ensure smoothlaboratory operation in accordance with the organization s policies, procedures, and state, federal andlocal laws and ensure compliance with current Good Manufacturing Practices (cGMP), USP, EP, JPand other regulatory requirements at all times.Required Competencies: Knowledge, Skills, and Abilities Basic proficiency in MS Word, Outlook, and Excel programs. Basic experience with various microbiological testing and environmental monitoring techniques. Basic knowledge of electronic laboratory management systems. Strong attention to detail. Basic organizational skills. Basic knowledge of cGMP, USP, EP, FDA/PDA, OSHA and other regulatory guidance documentsas relates to microbiological testing and environmental monitoring. Basic written and verbal communication skills. Ability to gown and maintain a sterile work environment. Ability to accurately and completely understand and follow SOP, test method and cGMPrequirements; uses good judgement and follows procedures. Basic GMP documentation skills. Knowledge of laboratory safety practices. Ability to pair with mentors for guidance as well as to collaborate with peers on day-to-day tasks;cooperative and works well with a team. Willingness to learn and share knowledge. Communicates effectively with peers, management and cross-functionally across the site. Basic knowledge of laboratory and aseptic processes. Ability to work under regular supervision. Basic critical reasoning and decision-making skills. Ability to pass an initial full physical with annual monitoring. Ability to deal appropriately with regulatory agencies during regulatory and non-regulatoryinspections.Duties and ResponsibilitiesPerforms routine laboratory and EM activities. Prepares schedules and sample labels. Performs tests such as (but not limited to) bioburden, Growth Promotion, incoming media/reagentQC, BI testing. Operates laboratory equipment used to provide sterile and depyrogenated materials. Read EM and testing plates and assess against alert and action levels as appropriate. Performs microbial isolation techniques, Gram stains and supports microbial identificationprocess. Performs environmental monitoring activities in support of manufacturing. Collects utility samples for analysis. Maintain qualification status on aseptic gowning, etc. Demonstrates aseptic technique when performing a Microbiological Test or EM. Perform testing/monitoring activities associated with protocols or special projects as required. Executes scheduled testing and monitoring activities within the QC lab and manufacturing facility. Communicates appropriately with peers and Laboratory Management regarding scheduledduties. Uses tracking tools as appropriate (EM batch release, sample trackers, etc.) Administrative tasks. Communicate effectively with management regarding more complex issues.Participate in departmental training initiatives. Document training per procedural and cGMP requirements. Actively seeks out opportunities to learn from others within and outside the department. Assist other analysts, freely sharing knowledge and experience. Executes best practices in the laboratoryPerform peer review of testing data. Review all data in accordance with applicable procedures and cGMP requirements. Ensure all testing is performed in a compliant matter. Complete all review in accordance with required timelines. Communicate effectively with peers, and demonstrate teamwork, with regards to results of reviewand corrections required.Performs general laboratory duties as assigned.Education and Experience High school diploma or equivalent required. Bachelor s Degree, particularly in Microbiology or Science related field, preferred.0-2 years of Related ExperienceGMP Aseptic Manufacturing and/or Laboratory/Clean Room Experience preferred. An equivalent combination of education / experience may substitute.Working Conditions The incumbent will be required to wear uniform/ PPE to work in a manufacturing, warehouse, orlaboratory environment. The incumbent may be fully gowned for extended periods of time within a restrictive movementenvironment. This may include standing, bending, reaching, kneeling, etc. The incumbent will have to perform work in a controlled environment with strict glove and gownrequirements. The incumbent will be required to maintain a safety alertness due to work around hazardousequipment and cytotoxic product. This position requires regular medical surveillance and may require incumbent to wear arespirator or gown. The incumbent must be able to distinguish colors and possess correctable vision to 20/20; annualeye exam is required. The incumbent may analyze data and work with spreadsheets and graphs on a daily basis. The incumbent may be working in a laboratory or manufacturing setting up to 6 hours per day. The incumbent must be able to lift/carry not more than 25 pounds.#LI-POSTAbout UsCOMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDEAt Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions."At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies. Associated topics: bacteria, biopharmaceutical, dietary, dietician, disease, drug development, healthcare, metabolism, nutrition, trauma
Celgene Phoenix, AZ, USA
Nov 14, 2019
Full time
Req #: Location: Phoenix, Arizona, United StatesJob Category: QualityWork Location: 620 N. 51st Avenue 85043Organization: Quality ControlShift: 2nd Shift_USAEmployee Status: Full-timeJob Type: RegularPurpose and Scope of PositionThe Associate Analyst, QC Microbiology, is responsible for routine and non-routine microbiologicaltesting and environmental monitoring in support of sterile product manufacturing. The AssociateAnalyst is also responsible for peer review and support activities in the laboratory to ensure smoothlaboratory operation in accordance with the organization s policies, procedures, and state, federal andlocal laws and ensure compliance with current Good Manufacturing Practices (cGMP), USP, EP, JPand other regulatory requirements at all times.Required Competencies: Knowledge, Skills, and Abilities Basic proficiency in MS Word, Outlook, and Excel programs. Basic experience with various microbiological testing and environmental monitoring techniques. Basic knowledge of electronic laboratory management systems. Strong attention to detail. Basic organizational skills. Basic knowledge of cGMP, USP, EP, FDA/PDA, OSHA and other regulatory guidance documentsas relates to microbiological testing and environmental monitoring. Basic written and verbal communication skills. Ability to gown and maintain a sterile work environment. Ability to accurately and completely understand and follow SOP, test method and cGMPrequirements; uses good judgement and follows procedures. Basic GMP documentation skills. Knowledge of laboratory safety practices. Ability to pair with mentors for guidance as well as to collaborate with peers on day-to-day tasks;cooperative and works well with a team. Willingness to learn and share knowledge. Communicates effectively with peers, management and cross-functionally across the site. Basic knowledge of laboratory and aseptic processes. Ability to work under regular supervision. Basic critical reasoning and decision-making skills. Ability to pass an initial full physical with annual monitoring. Ability to deal appropriately with regulatory agencies during regulatory and non-regulatoryinspections.Duties and ResponsibilitiesPerforms routine laboratory and EM activities. Prepares schedules and sample labels. Performs tests such as (but not limited to) bioburden, Growth Promotion, incoming media/reagentQC, BI testing. Operates laboratory equipment used to provide sterile and depyrogenated materials. Read EM and testing plates and assess against alert and action levels as appropriate. Performs microbial isolation techniques, Gram stains and supports microbial identificationprocess. Performs environmental monitoring activities in support of manufacturing. Collects utility samples for analysis. Maintain qualification status on aseptic gowning, etc. Demonstrates aseptic technique when performing a Microbiological Test or EM. Perform testing/monitoring activities associated with protocols or special projects as required. Executes scheduled testing and monitoring activities within the QC lab and manufacturing facility. Communicates appropriately with peers and Laboratory Management regarding scheduledduties. Uses tracking tools as appropriate (EM batch release, sample trackers, etc.) Administrative tasks. Communicate effectively with management regarding more complex issues.Participate in departmental training initiatives Document training per procedural and cGMP requirements. Actively seeks out opportunities to learn from others within and outside the department. Assist other analysts, freely sharing knowledge and experience. Executes best practices in the laboratoryPerform peer review of testing data Review all data in accordance with applicable procedures and cGMP requirements. Ensure all testing is performed in a compliant matter. Complete all review in accordance with required timelines. Communicate effectively with peers, and demonstrate teamwork, with regards to results of reviewand corrections required.Performs general laboratory duties as assigned. Education and Experience High school diploma or equivalent required. Bachelor s Degree, particularly in Microbiology or Science related field, preferred.0-2 years of Related ExperienceGMP Aseptic Manufacturing and/or Laboratory/Clean Room Experience preferred. An equivalent combination of education / experience may substitute.Working Conditions The incumbent will be required to wear uniform/ PPE to work in a manufacturing, warehouse, orlaboratory environment. The incumbent may be fully gowned for extended periods of time within a restrictive movementenvironment. This may include standing, bending, reaching, kneeling, etc. The incumbent will have to perform work in a controlled environment with strict glove and gownrequirements. The incumbent will be required to maintain a safety alertness due to work around hazardousequipment and cytotoxic product. This position requires regular medical surveillance and may require incumbent to wear arespirator or gown. The incumbent must be able to distinguish colors and possess correctable vision to 20/20; annualeye exam is required. The incumbent may analyze data and work with spreadsheets and graphs on a daily basis. The incumbent may be working in a laboratory or manufacturing setting up to 6 hours per day. The incumbent must be able to lift/carry not more than 25 pounds. About UsCOMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDEAt Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions."At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies. Associated topics: bacteria, biopharmaceutical, cytometry, drug discovery, food scientist, health, industrial hygienist, microbiology, protein, vaccine
Celgene Summit, NJ, USA
Nov 14, 2019
Full time
Req #: Location: Summit, New Jersey, United States Job Category: Quality Work Location: 556 Morris Avenue 07901 Organization: Quality Control Employee Status: Full-time Job Type: Regular Purpose and Scope of Position The LIMS Specialist is responsible for the management of the LIMS (Laboratory Information Management System)/ eLN (electronic lab notebook) in support of the chemistry and microbiology CAR-T QC laboratories with minimum supervision. This includes, but is not limited to, maintaining, updating and troubleshooting all LIMS/eLN related issues and assisting with system updates and/or enhancements. Required Competencies: Knowledge, Skills, and Abilities Advanced knowledge of LabWare or related LIMS/eLN Advanced knowledge of LIMS basic coding and code reviews Advanced knowledge of validation and/or maintenance of laboratory information systems Knowledge of cGMP Regulations and how they apply to QC laboratories Knowledge of analytical/microbiological test methods and environmental monitoring programs Knowledge of controlled barcode label printing Knowledge of Crystal Report design Ability to perform ADHOC inquires Strong written and verbal communication skills Detail-oriented with expertise in problem solving; solid decision-making abilities Strong interpersonal skills Strong ability to work independently and compliantly Results driven Duties and Responsibilities System Management Execute, Create or revise computer system validation documents (i.e. UAT, URS, OQ, PQ, etc.) as applicable Support Business buildouts and changes in LIMS/eLN for the QC lab Support IT in the Administration of the LIMS/eLN program Manage Business change controls for LIMS/eLN changes System Support Provide operations support to end users of the LIMS/eLN program Manage change controls for LIMS/eLN changes Provide expertise in the execution of business processes using LIMS/eLN system Troubleshoot issues and solve problems with minimum guidance Assist with errors and troubleshooting Assist users with enhancements, URD and URs gathering Provide end user training and on-the-job training (OJT) for laboratory and production employees where required Participate in internal audit of the system and system documentation Assist management with investigations and deviations Create and maintain LIMS related SOPs Support site projects and goals where applicable to streamline testing Function as system superuser where applicable Guide QC end users on the development of system enhancements with user requirements and business drivers Master Data Management Maintain master data objects Guide QC personnel on creating masterdata sets Training Assist with the development, implementation and deployment of training Provide end user training and on-the-job training (OJT) for laboratory and production employees where required Performs other tasks as assigned. Education and Experience Bachelor's Degree required, preferable in Science Advanced Degree preferred 5-8 years of relevant work experience, preferable in a regulated environment. 3-5 years of LabWare or related LIMS experience Previous experience with validation and/or maintenance of laboratory information systems Previous experience in a GMP QC role a plus An equivalent combination of education and experience may substitute Working Conditions The incumbent will be expected to work flexible hours where needed including some weekends The incumbent will be working a laboratory setting up to six (6) hours per day. The incumbent will be working around biohazardous materials, including chemical agents, up to six (6) hours per day. #LI-POST About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.