Celgene

Celgene Colorado, USA
Sep 20, 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 Colorado, USA
Sep 19, 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 Berkeley Heights, NJ, USA
Sep 18, 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
Sep 18, 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 Berkeley Heights, NJ, USA
Sep 18, 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
Sep 18, 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 join the team. This individual will be responsible for leading a team that is developing functional characterization and QC release assays for novel cellular therapeutics. The Scientist will be passionate about developing novel medicines, thrive in an intellectually challenging environment, and enjoy collaborating with a team of likeminded Scientists. This Scientist will lead teams that are developing assays that functionally characterize exciting new cellular therapeutics that are currently undergoing clinical trials, including CAR T cells. As a member of the Potency Group, which is part of the Immunoassays Team within Analytical Development, the Scientist will oversee the design, execution, and analyses of experiments that lead to the development of methods that evaluate drug potency. The Scientist will be responsible for developing impactful extended characterization methods that support process development, comparability assessments and QC release assays. The Scientist will work closely within the Immunoassays Team, which in addition to Potency has the responsibility for methods that measure Identity, Purity, and Strength. The candidate will have a background in Immunology or related field and will be involved in projects requiring close collaboration with other groups, including process development, discovery research, product sciences, and QC. Qualifications and Education Requirements • PhD degree with 2-6 years of experience in the field of Immunology, Cancer Biology, or related field, preferably in an industry setting. • Demonstrated experience leading teams and managing direct reports. • Expertise developing, qualifying, and transferring cell-based assays, ELISAs, and/or similar technology platforms (e.g. MSD, Luminex, AlphaLISA, etc). • Experienced with authoring and revising test methods, forms, protocols, and reports. • Proficient 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. • Experienced with Design of Experiment (DoEs) using JMP or equivalent statistical software. Preferred Qualifications • 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. • Method trending, automation, method transfers, establishing critical reagent strategies, and method lifecycle management. 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. • Facilitate the establishment of best practices for method development, transfers, and lifecycle management of analytical methods. • Collaborate with discovery research, process development, product sciences, QC, and other departments and stakeholders to facilitate the identification of new functional characterization methods to develop. • Proficient 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 Phoenix, AZ, USA
Sep 17, 2019
Full time
Req #: Location: Phoenix, Arizona, United States Job Category: Quality Work Location: 620 N. 51st Avenue 85043 Organization: Quality Operations Employee Status: Full-time Job Type: Regular Purpose and Scope of Position: The Associate Specialist, Compliance and Laboratory Oversight carries out Quality Oversight responsibilities in accordance with the organization's policies, procedures and Good Manufacturing Practices. This position provides specific oversight for the QC laboratories ensuring the safety, quality, potency and purity of injectable pharmaceutical products manufactured in Phoenix. The Associate Specialist will ensure routine compliance with global cGMP's and corporate policies, as well as site and departmental procedures. Required Competencies: Knowledge, Skills, and Abilities • Intermediate knowledge of lab systems and equipment including electronic systems • Intermediate knowledge of cGMP, OSHA, and USP • Able to properly communicate routine business matters with management, with high level of accuracy • Intermediate computer skills • Basic scientific knowledge • Intermediate organizational and time management skills • Intermediate writing skills and ability to follow technical reports • Intermediate teamwork and facilitation skills • Able to learn from mistakes and actively listen. Must be action-oriented and customer-focused and possess learning agility. Duties and Responsibilities • Assures appropriateness of documentation to maintain site compliance and product quality. • Specifications and test methods • protocols • SOPs • Works with Laboratory Management to ensure compliance with cGMPs, SOPs, and policies. • Collaborates with Laboratory Management to assist in initiatives to improve compliance as needed. • Provides feedback to Laboratory and Quality Management in relation to findings/observations during routine review. • Assist with routine reviews/audits of laboratory operations and associated systems. • Data review • Performs review of laboratory data and documentation • Performs review of test practices for a predefined percentage of incoming, bulk, finished product, stability, water, and environmental testing • Data review of applicable equipment/system audit trails • Compendia review • Assures integrity of data across paper and electronic systems/equipment utilized in the laboratory. • Supports global initiatives • laboratory data integrity • OOS/OOT • stability program management • Performs all other tasks as assigned Education and Experience • Bachelor's degree preferred. • 3 years' of relevant Quality Assurance Laboratory work experience in a GMP environment is required. Experience with Data Review of Electronic Systems is required. • An equivalent combination of education, experience and training may substitute. Working Conditions: Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc. #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 San Diego, CA, USA
Sep 17, 2019
Full time
Req #: Location: San Diego, California, United States Job Category: Clinical Operations Work Location: 3033 Science Park Road 92121 Organization: Biostatistics Employee Status: Full-time Job Type: Regular Associate Director Biostatistics - Biometrics and Data Operations You will serve as the global lead statistician in the support of trial Phases I-III of drug development for a therapeutic area As a Celgene Associate Director, your background includes a Ph.D. in Statistics with 8+ years (or 10+ years for MS) pharmaceutical experience as a statistician supporting clinical trials. Your Responsibilities will include, but are not limited to, the following: 1. Actively provide statistical support to Celgene Research and Development. • Serves as the global lead statistician in the support of trial Phases I-III of drug development for a therapeutic area. • Manages multiple studies within an indication or therapeutic area. • Serves as an advisor to statisticians assigned to the project to ensure high quality and timely deliverables. • Guides global staff in the preparation of Statistical Analysis Plans. Shepherds the plan through clinical review to ensure worldwide organizational acceptance of the statistical design, endpoints, and proposed analyses. • Ensures consistency and adherence to standards within a project. • Contributes to Clinical Development Plans, submissions and post-submission strategies, preparations and defense, ensuring quality and timing thereof. • Provides statistical support for Health Authority requests, publications, presentations, and posters at medical conferences/symposia, as assigned. • Contributes to, and provides training on new departmental statistical topics, SOPs, WPs. • Impacts directly on overall business and Biostatistics performance through the ability to influence and work in a consultative manner with senior stakeholders. 2. Sets project level priorities. 3. Manages resources to meet project team timelines. 4. Escalates issues to functional management as necessary. 5. Makes recommendations or resolves technical, quality, and timeline issues. 6. Manages outside CROs and contractors. 7. Recommends external statistical experts for consultation. 8. Provides guidance to employee's development plan and carries out performance review and feedback 9. Evaluates the effectiveness of Biostatistics programs, policies, and processes to meet evolving stakeholder needs 10. Leverages best practices in Biostatistics management to enhance efficiencies. 11. Provides directions to project teams using statistical expertise and project knowledge. 12. Manages team conflicts to resolution and improved team collaboration. 13. Maintains close collaboration and working relationships with stakeholders. 14. Manages conflicts with external partners/customers. 15. Represents Biostatistics function at cross-functional meetings. 16. Oversees/coordinates biostatistical activities on global submission teams. 17. Partners with senior line management to shape Biostatistics strategy in alignment with the business strategy. 18. Works closely with stakeholder leaders to develop and implement high impact business initiatives. 19. Leverages existing Biostatistics programs, policies, and procedures to create value-added solutions for Biostatistics. 20. Provides proactive expertise, coaching, and counseling to stakeholder leaders, employees, and peers on complex Biostatistics and stakeholder issues. 21. Provides leadership • Sought out thought leader, providing coaching and mentoring to peers, Statisticians/Programming team members and others • Provides continuous feedback to peers and leaders • Proactively seeks ways to gain broader experience/perspectives and focuses on a robust professional development plan • Leads cross-functional collaboration and conducts meetings to gain the trust and respect of members, make decisions on business issues and freely challenges and expresses opinions • May manage and or develop staff; provide coaching and mentoring, monitors other's performance, makes recommendations on resource allocations and provides feedback via formal/informal appraisals Skills/Knowledge Required: • Ph.D. in statistics (or related field) with a focus on statistical methods appropriate for clinical trials. • Experience in clinical drug development: 8+ years for Ph.D., • Demonstrated skill in the planning, analysis and reporting of clinical trials. • Detailed knowledge of statistical methodologies, relevant therapeutic areas, and statistical regulatory requirements. • Previous experience in leading and completing a task force or supervising statisticians. • Abreast of clinical trial design concepts. • In-depth knowledge of all phases of the drug development process. • Demonstrated ability to work in a team environment with clinical team members. • Good interpersonal, communication, writing and organizational skills. • Abreast of statistical method development and able to decide on the optimal methods acceptable to regulatory agencies. • Abreast of relevant project area's clinical trial development and regulatory requirements. • Establishes performance standards and commits to evaluation and review of developmental opportunities. #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
Sep 17, 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 What great looks like in this role Our ideal Statistician for the role has a Ph.D. in Statistics with at least two years' experience in clinical drug development. You'll use your skills to actively provide statistical support to the Clinical Research and Development Department, contributing to efficient study design, preparing statistical consideration sections and providing input into other protocol sections. You're a skilled relationship builder who can work through conflict to achieve high quality results. You'll use your experience to provide recommendations on technical, quality and timeline issues. This is a great opportunity to broaden your skills within the pharmaceuticals industry as a Senior Statistician. Objectives of this Role • Actively provide statistical support to the Clinical Research and Development Department, contributing to efficient study design, preparing statistical consideration sections and providing input into other protocol sections. Daily and Monthly Responsibilities • Prepare statistical analysis plans including table shells. • Analyze clinical trial data; work with programmers to provide tables, listings and graphs, including ad hoc validation. • Review, synthesize, interpret and report analysis results, including ad hoc requests for analyses. • Provide statistical input for the preparation of final study reports and other required documents, including manuscripts. • Provide statistical support for integrated reports, submissions preparation, and post-submission activities. • Provide project requirements to programmers. • Manage outside CROs and consultants as needed. • Escalates issues to functional management as necessary. • Makes recommendations or resolves technical, quality, and timeline issues. • Provides leadership. • Provides continuous feedback to peers and leaders. • Proactively seeks ways to gain broader experience and perspectives with focus on a robust professional development plan. Knowledge and skills required • Ph.D. or MS. in statistics with a focus on statistical methods appropriate for clinical trials. • Experience in clinical drug development at least 2 years' experience for Ph.D. or 5 years for MS. • Demonstrated skill in the analysis and reporting of clinical trials. • Knowledge of statistical methodologies and statistical regulatory requirements. • Knowledge of statistical computing software (e.g. SAS or R). • Knowledge of MS Office products (Word, Excel, PowerPoint). 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 Arkansas, USA
Sep 17, 2019
Full time
Req #: Location: Dallas, Texas, United States Job Category: Quality Work Location: Quadrangle Tower - 2828 Routh St Suite Organization: Quality Operations Employee Status: Full-time Job Type: Regular PURPOSE AND SCOPE OF POSITION: Lead GMP/GDP/GTP audits of vendors (Contract Service Providers, Material Suppliers and Apheresis Collection Centers), in order to assess compliance with regulatory and Celgene requirements, to identify Quality Risks and drive concurrence regarding their severity. Participate in annual assessment of vendors and projects related to processes for GMP/GDP/GTP audit and vendor management. This is a remote-based position to be located near a major airport hub in order to carry out audit duties, responsibilities, and travel requirements. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities Must have good GMP, Quality, and risk management knowledge. Must be able to prepare written communications and communicate problems to management with clarity and accuracy. Must have broad technical and scientific knowledge. Understands fundamental scientific problems. Must be able to write and review reports with clarity and brevity. Must be able to produce data reports with precision. Must be action-oriented and customer-focused and skilled in decision making, building relationships, problem identification/solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking. Must possess an independent mindset and tenacity Good knowledge of all relevant regulations and deeper knowledge of relevant laws / regulations in GMP/GDP/GTP area(s); ability to translate regulations into operational requirements. Good knowledge of all relevant Company policies / procedures / standards with deeper knowledge of Company policies / procedures / standards in GMP/GDP/GTP area(s). Good knowledge of assigned Celgene business units, processes, management systems, products, services, and technologies Organization and planning abilities with attention to detail. Understanding of risk management and ability to evaluate an organization's risk exposure. Proficient in Microsoft Office and other standard applications. Good understanding of business functions and internal controls to assess compliance in auditee organizations. Considers and incorporates global perspectives and requirements. Effective written and verbal communications. Drives execution. Engagement planning and management toward timely and quality completion of objectives Defines plan for audit conduct and determines seriousness of findings and risks; determines if and when to escalate risk or other aspects of audit to management. Training and coaching skills. Healthy skepticism. Commitment to self-development and ability to stay abreast of internal and external requirements. DUTIES AND RESPONSIBILITIES Audit Planning and Schedule Development Schedule audit with the audited entities, according to audit schedule. Lead preparation meetings with internal stakeholder Audit Preparation In collaboration with management, define the scope and depth of the draft audit agenda. Review auditee's audit history and other supporting information; provide to audit team members for use in preparation activities. Meet with the business, audit team and SMEs to refine the risk assessment, ensure all risks are identified, and finalize the audit agenda. Issue audit agenda; request required pre-audit information from the auditee. Ensure that the audit owner and potential observation owners are identified; lead resolution of issues regarding identification of owners. Resolve schedule issues and escalate issues where appropriate. Lead pre-audit team meeting; review pre-audit information with the audit team. Audit Conduct Conduct opening meeting with the auditee, auditee SMEs and Celgene audit team, including Celgene SMEs, to review the agenda and confirm agreement on scope and timelines. Lead or participate in the execution and conduct of the audit. Ensure the audit team uses relevant audit guidelines and that the team executes the defined audit agenda. Lead or participate in all Celgene audit team/SME meetings and joint auditee/Celgene audit team meetings that occur during and at end of the audit; verify audit observations with auditees. Ensure that findings and observations are identified, evidence is collected where possible, all potential critical observations are immediately identified, and auditee expectations and next steps are identified. Escalate potentially critical observations to the Head of GMP/GDP Compliance. Adhere to the Auditor Code of Conduct in planning and executing audits. Audit Reporting In collaboration with management, lead the grading of observations and the identification of observation and effectiveness check requirements, ensuring that differences in opinion are resolved. Collate and edit the draft audit report. Provide draft audit report to the management and the audit team, for feedback; finalize the report and distribute per procedures. Audit Follow-Up Review and track all observation responses and observation actions that result from an audit. Determine if observation responses are complete and if not, negotiate with observation owner(s). Review evidence to determine if it is acceptable and negotiate revised dates with the observation or action owner(s) if needed. Escalate all overdue and unacceptable responses Determine when an observation can be closed; issue Audit Certification and Audit Closure documentation. Review timeline extension requests for observation actions to determine if justification and new due date are acceptable; reject unacceptable requests. Communicate decision and rationale to observation or action owner. Ensure that the subject of the extension request is updated with new date. Compliance, Standards, and Training Support establishing and maintaining audit procedures (SOP's, Standards) under the direction of the Associate Director GMP/GDP/GTP Audits. Contribute to the delivery of training in areas of specialization. Manage performance of audit team during audit engagements. Work collaboratively with other auditors to ensure consistency in auditing process. Continuous Improvement and Project Management Contribute to projects regarding Audit and Vendors Management improvement initiatives. Contribute to the internal departmental efforts to analyze internal metrics, identify and characterize issues, determine root causes, and plan improvement activities. Contribute to the review and analyses of KPIs Other Responsibilities Other quality management activities as assigned. EDUCATION AND EXPERIENCE (As Applicable) Minimum of B.S. or the equivalent combination of relevant education or professional experience. Minimum of five years of relevant GMP/GDP pharmaceutical/biotechnology auditing experience. Ability to travel upwards of 70% within the Continental United States and Canada is required. Ability to be based in the Southwest United States Region is preferred, but not required. DEFINITIONS AND ABBREVIATIONS GMP Good Manufacturing Practice GDP Good Distribution Practice GTP Good Tissue Practice HA Health Authority CSP Contract Service Provider #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 Seattle, WA, USA
Sep 17, 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 Seattle, WA, USA
Sep 17, 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 join the team. This individual will be responsible for leading a team that is developing functional characterization and QC release assays for novel cellular therapeutics. The Scientist will be passionate about developing novel medicines, thrive in an intellectually challenging environment, and enjoy collaborating with a team of likeminded Scientists. This Scientist will lead teams that are developing assays that functionally characterize exciting new cellular therapeutics that are currently undergoing clinical trials, including CAR T cells. As a member of the Potency Group, which is part of the Immunoassays Team within Analytical Development, the Scientist will oversee the design, execution, and analyses of experiments that lead to the development of methods that evaluate drug potency. The Scientist will be responsible for developing impactful extended characterization methods that support process development, comparability assessments and QC release assays. The Scientist will work closely within the Immunoassays Team, which in addition to Potency has the responsibility for methods that measure Identity, Purity, and Strength. The candidate will have a background in Immunology or related field and will be involved in projects requiring close collaboration with other groups, including process development, discovery research, product sciences, and QC. Qualifications and Education Requirements • PhD degree with 2-6 years of experience in the field of Immunology, Cancer Biology, or related field, preferably in an industry setting. • Demonstrated experience leading teams and managing direct reports. • Expertise developing, qualifying, and transferring cell-based assays, ELISAs, and/or similar technology platforms (e.g. MSD, Luminex, AlphaLISA, etc). • Experienced with authoring and revising test methods, forms, protocols, and reports. • Proficient 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. • Experienced with Design of Experiment (DoEs) using JMP or equivalent statistical software. Preferred Qualifications • 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. • Method trending, automation, method transfers, establishing critical reagent strategies, and method lifecycle management. 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. • Facilitate the establishment of best practices for method development, transfers, and lifecycle management of analytical methods. • Collaborate with discovery research, process development, product sciences, QC, and other departments and stakeholders to facilitate the identification of new functional characterization methods to develop. • Proficient 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 Bothell, WA, USA
Sep 12, 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 . 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
Sep 10, 2019
Full time
Req #: Location: Berkeley Heights, New Jersey, United States Job Category: Information Technology Work Location: 300 Connell Dr 07922 Organization: Clinical Programming Employee Status: Full-time Job Type: Regular Job Description Responsibilities will include, but are not limited to, the following: Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells. Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs. Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results. Ensure consistency and adherence to standards within their therapeutic area. Provide input to the design of the clinical trial database for proper data capture and to ensure data quality. Create Data Definition Tables (DDT) and converting TFLs to the required format for eSubmission. Convert, verify and integrate multiple sources of incoming data for the creation of analysis datasets. Provide programming support for the preparation of integrated reports, submissions and post-submission activities. Serve as the lead programmer in support of NDAs, sNDAs. Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros. Provide training on departmental SOPs/WPs and standard programs. Contribute to the creation of naming conventions and standards for the programming environment. Routinely interface with cross-functional team members. Influences other functions and represents as DOP technical expertise. Represent as internal team leader who decides best course of action. Coach and advise junior programmers to identify problems and solutions. Oversee the services provided by CROs. Skills/Knowledge Required: Bachelor's degree in life science, statistics, mathematics, computer science, or related field is required; Master's degree is preferred. 9 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with a Bachelor's degree; or 8 plus years experience with a MS/MA degree. Demonstrated proficiency in using SAS to produce derived analysis datasets and produce TFLs. Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats. Demonstrated skills in using additional software tools and applications (e.g. MS office, XML). Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM. Demonstrated expertise in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission. In-depth understanding of regulatory, industry, and technology standards and requirements. Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs. Demonstrated ability to work in a team environment with clinical team members. Excellent planning and project management skills. Good interpersonal, communication, writing and organizational skills. Keep abreast of evolving regulatory, industry, and technology changes and demands, e.g., CDISC, SDTM, ADaM, eDC. #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 Seattle, WA, USA
Sep 09, 2019
Full time
Req #: Location: Seattle, Washington, United States Job Category: Clinical Operations Work Location: 400 Dexter Ave N. 98109 Organization: Biostatistics Employee Status: Full-time Job Type: Regular As our Principal Statistician (Cell Therapy CMC) you are responsible for providing statistical support to the Cell Therapy CMC teams. Serves as primary Biostatistician on multiple analytical and manufacturing process related activities. Participates in the development of protocols and statistical analysis plans. Performs statistical analysis, interprets statistical results, and participates in the preparation of study reports. Oversees the work of others 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; Experience with the statistical aspects of Analytical method development, qualification, validation, transfer, comparability and troubleshooting. Experience with the statistical aspects of Process development, characterization, comparability, PPQ and troubleshooting. Experience with the statistical aspects of translational development, stability analysis & shelf life determination and specification setting. Review programming and analysis specifications; Write statistical analysis plans; Perform statistical analyses of CMC data using JMP / SAS and other statistical software packages as necessary. Oversee the work of scientists / engineers that are performing statistical analyses of CMC 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 CMC drug-development environment; Experience or training with a wide-range of skills including JMP/ SAS programming and other relevant statistical software such as Minitab and / or R, 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.