Celgene

Celgene Berkeley Heights, NJ, USA
Jul 18, 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 Summit, NJ, USA
Jul 18, 2019
Full time
Req #: Location: Summit, New Jersey, United States Job Category: Sales and Marketing Work Location: 86 Morris Avenue 07901 Organization: Channel Marketing Employee Status: Full-time Job Type: Regular Come Join Celgene's Organized Customer Marketing team! In this role, you will drive development and implementation of Celgene access strategies to support inline and launch performance across targeted Payer, PBM, & Provider System entities. This position will oversee the assessment, research, creation, and implementation of a strategy to establish a position for Celgene within these critical customer segments to ensure patient access across the portfolio. This position will work closely with the Head of Organized Customers, Access & Value Marketing, and Brand Marketing to develop and implement objectives tied to brand strategy and revenue forecasts. Responsibilities: Collaborate with Access & Value Marketing across Hematology/Oncology and Inflammation & Immunology to develop Payer, PBM, & Provider System strategies Identify key customer segments within Payer, PBM, & Provider Systems and pinpoint high-level customer needs to inform product value proposition development Identify impact and implications of organized customer trends including risks and mitigation strategies across in-line and launch products Communicate organized customer channel strategies and provide channel insights and expertise to inform contract strategy and brand planning across the portfolio Support implementation and continued assessment of strategy to drive inline and launch performance across internal & 3rd party pathways. Partner with the field on customer insight generation and supplement with external information and data to become expert in the organized customer groups Build trusting partnerships with account management and key Market Access leaders Establish key business metrics to measure success and execution Leverage customer insights to drive and guide the development of new platforms & customer partnerships Stakeholder Relationships Reports to Director, Organized Customer Marketing (Celgene Access Marketing) Interacts internally with team representatives from Brand Marketing, Health Economics and Outcomes Research, Market Research, Field Sales, Account Management, Analytics Ensures strong collaboration across functions to strengthen patient and organized customer value story and provides timely communication of insights to all relevant partners Direct working relationship with sales and analytics to create pull through strategy, messaging, and KPIs External relationships include interactions with managed markets customers across the Payer, PBM, & Provider System segments Required Skills/Experience: A bachelor's degree in related field. A minimum of 5 years of experience in any of the following areas: pricing, contracting, managed markets strategy, or value communication within payer and/or provider system marketing, national account management, consulting, and/ or market access strategy A minimum of three (3) years of experience in the pharmaceutical industry Strong understanding of the US payer environment, Payer, PBM, and Provider System market dynamics, payer marketing principles and how market access organizations and at-risk networks make decisions across private & public channels Strong interpersonal; communication; analytical and project management skills. Ability to access and influence various functional areas and motivate groups to action without direct line management responsibility Preferred Skills/Experience: MBA and/or advanced degree in scientific field (e.g., MPH, PharmD, PhD) highly preferred. Relevant experience may be substituted for advanced degree, when appropriate *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
Jul 17, 2019
Full time
Req #: Location: Seattle, Washington, United States Job Category: Research and Early Development Work Location: 400 Dexter Ave N. 98109 Organization: Translational Medicine Employee Status: Full-time Job Type: Regular Summary: Celgene is looking for a candidate to join the Protein Sciences team within the Immuno-Oncology and Cellular Therapy Department in Seattle. What great looks like in this role: Our ideal candidate will be an experienced and independent self-starter and is able to think outside of the box. You have a deep understanding of and experience with SPR (Biacore), basic biochemistry principles, protein structure, and extensive laboratory experience with development and implementation of assays analyzing protein-protein, as well as protein-cell interactions. In this role, you will be responsible for the deployment of kinetics instruments (Biacore and KinExA) to better understand Cellular Therapies developed at Celgene. In addition, you will independently evaluate new biophysical methods and technologies to deepen the understanding of CAR-T cell biology. This role provides a unique opportunity to combine basic protein biochemistry with advanced biophysical instrumentation to understand a new and exciting field of cancer therapy. Objective of this role Development of custom affinity assays and biochemical assays (ELISA, immune precipitation) Daily maintenance and operation of SPR (Biacore) and Kinetic Exclusion Assay (KinExA) instrumentation Delivery of high quality kinetics data and epitope binning data using a wide range of protein/cellular reagents Key Responsibilities: Design, and implementation of kinetic assays using cells and recombinant proteins Routine buffer and sample preparation of reagents used in kinetics assays Record experimental details and maintain laboratory notebook in accurate and timely manner Cultivate positive and productive working relationships with colleagues Prepare and present work at group meetings Participate in maintenance of routine laboratory instrumentation and supplies Minimum Qualifications: Bachelor's degree in Biochemistry (or relevant discipline) and minimum of 8+ years of pharmaceutical laboratory experience required; or Master's degree and minimum of 6+ years of pharmaceutical laboratory experience required; In depth knowledge of and demonstrated expertise operating SPR (Biacore) instrumentation Deep understanding of principles of chemistry, biochemistry, as well SPR and kinetic exclusion assay experimental design Thorough understanding of affinity, avidity, and kinetics concepts Demonstrated ability to develop novel kinetics assays using traditional and non-traditional protein reagents (mAb, scFv, Fc-Fusion, bi-specific antibodies, recombinant receptors, crude serum, VLPs). Experience with epitope binning of antibody and antibody like molecules Ability to multitask, independently organize time and plan specifics of work Excellent communication and interpersonal skills demonstrated in a team environment A strong team player that brings people along through a supportive, engaged and creative way of working Excellent communication and presentation skills. Preferred Qualifications: Experience handling cells is highly preferred Ability to perform protein purification and modification is highly preferred Hands on experience operating kinetic exclusion assay (KinExA) instrumentation Ability to work independently but also in a collaborative manner with local and cross-site teams Strong understanding of protein folding and structure 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
Jul 15, 2019
Full time
Req #: Location: Summit, New Jersey, United States Job Category: Market Access Work Location: 86 Morris Avenue 07901 Organization: Market Access/Pricing Employee Status: Full-time Job Type: Regular Come join Celgene's Global Pricing & Market Access organization! In this Health Economics and Outcomes Research (HEOR) role, you will support Celgene's Myeloid and Lymphoma products through developing and executing HEOR strategy for products across lifecycles. You will work closely in partnership with Myeloid and Lymphoma Market Access Leads to support the market access & pricing strategy. This role will also require collaboration internally with clinical development, medical affairs and other cross functional colleagues as well as externally with HEOR experts to build an integrated evidence generation plan for Celgene's Myeloid portfolio to achieve business objectives. Responsibilities will include, but are not limited to, the following: Develop and execute health economic & outcomes research strategy for Celgene's Myeloid and Lymphoma assets across early development to post launch lifecycle Lead the execution of HEOR studies and data dissemination, including but not limited to systematic literature reviews, burden of illness, real-world studies, economic modeling, patient-reported outcomes, comparative effectiveness studies, etc. Work in partnership with Global Market Access Leads to support Market Access & Pricing strategy and to ensure full alignment in evidence generation plan for Market Access objectives Engage local team and external experts for global HEOR strategy development and research execution to address local market access needs, and support evidence needs for local HTA/payer submission Collaborate with cross-functional teams, e.g. clinical development, medical affairs, regulatory, biostatistics to integrate HEOR plan in overall evidence generation plan Develop and manage Myeloid & Lymphoma HEOR budgetary plan to ensure optimal allocation and prioritization of HEOR resources to support business objectives Skills/Knowledge/Experience Required : 8+ years' experience in healthcare or bio-pharmaceutical with in-depth understanding of regulatory and payer system in key global markets, evolving Market Access environment and the implications to the evidence needs by external stakeholders Proficient in leading and conducting HEOR projects with hands-on experience in SLR, burden of illness study, retrospective database/registry/chart review real-world studies, cost-effectiveness & budget impact model development, comparative effectiveness methodologies and patient-reported outcomes strategy. Hands-on experience in supporting product launch and achieving reimbursement in hematology/oncology disease states Strong awareness and knowledge of the latest HEOR methodologies and approaches in the marketplace and how they can be employed to advance product value propositions Solid scientific knowledge and ability to evaluate clinical programs and identify evidence gaps Significant knowledge & experience in creating product value proposition and value messages with supporting evidences Can effectively liaise with cross-functional franchise and disease teams as well as Celgene's global, local and regional teams with an efficient and collaborative working style Skills/Knowledge/Experience Preferred: Experience in local reimbursement submission and payer negotiations preferred Competencies Required : Displays excellent business acumen, creative and strategic thinking, problem-solving and decision-making abilities Has excellent written, verbal and interpersonal communication skills, with the ability to communicate complex or technical content in a convincing way to non-technical audiences. Has strong influencing/negotiation skills and the ability to work at peer-level with experienced clinical, regulatory and commercial experts Is comfortable working in a rapidly evolving scientific and competitive landscape with a high degree of ambiguity. Ability in prioritizing and managing multiple projects simultaneously and delivering results in a timely manner. *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
Jul 14, 2019
Full time
Req #: Location: Seattle, Washington, United States Job Category: Technical Development Work Location: 400 Dexter Ave N. 98109 Organization: Supply Chain Employee Status: Full-time Job Type: Regular Other Locations: United States-Indiana-Indianapolis, United States-Ohio-Cleveland, United States-Ohio-Columbus Patient Operations specializes in the supply chain functions that are unique to managing cellular therapy products. Our focus is on delivering timely, accurate and customer focused service to our customers. Our Patient Operations department has an opportunity for a Support Specialist to join the team supporting operations functions for the Ohio Valley region. Ideally, this position will be based in Seattle, however highly qualified remote candidates will be considered. Job Summary: The primary focus of the Apheresis Support Specialist role is to assist with the qualification, training, and management of the cell collection network. The Specialist will also be involved in site evaluations and on-going assessments of collection centers and Juno requirements. This is a critical role within the Patient Experience organization that requires someone with demonstrated experience working in a regulated environment, exceptional communication and organizations skills, as well as the flexibility to travel up to 50%. Job Description: Work with internal and external business partners to ensure cell collection centers successfully complete all qualification activities and are prepared to perform collections for Juno within the required timelines. Track qualification activities for assigned sites and communicate timeline delays to team. Work with manager to develop and execute mitigation plans for delayed timelines. Provide Quality Systems support by participating in deviation/change management activities and impact/investigation assessments for cell collection centers. Work with Quality Assurance and other internal business partners to monitor and assess vendor performance and capacity after site launch. Represent the department on cross-functional project teams, as requested. Comply with applicable SOP's and FDA regulations. Minimum Qualifications for Specialist, Apheresis Operations Support: Bachelor's degree; ideally in Life Sciences 3+ years of experience working in a regulated environment (e.g. GMP, GCP, GTP, Joint Commission, FACT, AABB) Ability to enjoy a high paced environment, meet deadlines, and prioritize work from multiple projects Ability to build effective relationships across company teams, and with external partners Strong teamwork skills and excellent customer service skills Accurate, responsive, and thorough communicator (both oral and written) Minimum Qualifications for Senior Specialist, Apheresis Operations Support: Bachelor's degree; ideally in Life Sciences 6+ years of experience working in a regulated environment (e.g. GMP, GCP, GTP, Joint Commission, FACT, AABB) Ability to enjoy a high paced environment, meet deadlines, and prioritize work from multiple projects Ability to build effective relationships across company teams, and with external partners Strong teamwork skills and excellent customer service skills Accurate, responsive, and thorough communicator (both oral and written) Preferred Qualifications: Knowledge of Apheresis and Good Tissue Practices Experience working in Cellular Therapy or Stem Cell Transplant programs Experience working with critical raw material suppliers or contract manufacturing organizations Experience in project coordination or management Experience with adult learning principles 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
Jul 14, 2019
Full time
Req #: Location: Seattle, Washington, United States Job Category: Technical Development Work Location: 400 Dexter Ave N. 98109 Organization: Supply Chain Employee Status: Full-time Job Type: Regular Other Locations: United States-Florida-Miami, United States-Florida-Orlando, United States-Florida-Tampa, United States-Georgia-Atlanta, United States-North Carolina-Raleigh Patient Operations specializes in the supply chain functions that are unique to managing cellular therapy products. Our focus is on delivering timely, accurate and customer focused service to our customers. Our Patient Operations department has an opportunity for a Support Specialist to join the team supporting operations functions for the US Southeast region. Ideally, this position will be based in Seattle, however highly qualified remote candidates will be considered. Job Summary: The primary focus of the Apheresis Support Specialist role is to assist with the qualification, training, and management of the cell collection network. The Specialist will also be involved in site evaluations and on-going assessments of collection centers and Juno requirements. This is a critical role within the Patient Experience organization that requires someone with demonstrated experience working in a regulated environment, exceptional communication and organizations skills, as well as the flexibility to travel up to 50%. Job Description: Work with internal and external business partners to ensure cell collection centers successfully complete all qualification activities and are prepared to perform collections for Juno within the required timelines. Track qualification activities for assigned sites and communicate timeline delays to team. Work with manager to develop and execute mitigation plans for delayed timelines. Provide Quality Systems support by participating in deviation/change management activities and impact/investigation assessments for cell collection centers. Work with Quality Assurance and other internal business partners to monitor and assess vendor performance and capacity after site launch. Represent the department on cross-functional project teams, as requested. Comply with applicable SOP's and FDA regulations. Minimum Qualifications for Specialist, Apheresis Operations Support: Bachelor's degree; ideally in Life Sciences 3+ years of experience working in a regulated environment (e.g. GMP, GCP, GTP, Joint Commission, FACT, AABB) Ability to enjoy a high paced environment, meet deadlines, and prioritize work from multiple projects Ability to build effective relationships across company teams, and with external partners Strong teamwork skills and excellent customer service skills Accurate, responsive, and thorough communicator (both oral and written) Minimum Qualifications for Senior Specialist, Apheresis Operations Support: Bachelor's degree; ideally in Life Sciences 6+ years of experience working in a regulated environment (e.g. GMP, GCP, GTP, Joint Commission, FACT, AABB) Ability to enjoy a high paced environment, meet deadlines, and prioritize work from multiple projects Ability to build effective relationships across company teams, and with external partners Strong teamwork skills and excellent customer service skills Accurate, responsive, and thorough communicator (both oral and written) Preferred Qualifications: Knowledge of Apheresis and Good Tissue Practices Experience working in Cellular Therapy or Stem Cell Transplant programs Experience working with critical raw material suppliers or contract manufacturing organizations Experience in project coordination or management Experience with adult learning principles 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
Jul 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. Remaining current with required GMP training and qualifications. Apply cGMP principles by following internal standard operating procedures (SOPs), work practices (WPs), and regulatory requirements. 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. Implement strategic plans for the kilo lab area, including operational enhancements, new equipment/capability purchase and installation, capacity expansion, etc.. Assist in developing and managing 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. 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 related to project activities. 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 or higher degree in Chemistry, Chemical Engineering, or closely related discipline, or relevant experience in lieu of degree. Minimum of 8 years experience in the pharmaceutical industry in small molecule drug substance development and facility 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, GMP/non-GMP manufacturing, 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 Seattle, WA, USA
Jul 14, 2019
Full time
Req #: Location: Seattle, Washington, United States Job Category: Information Technology Work Location: 400 Dexter Ave N. 98109 Organization: Information Technology Employee Status: Full-time Job Type: Regular Other Locations: United States-California-San Francisco Juno, a Celgene company, is seeking a Business Analyst to support Cell Therapy Digital Platform in the analysis of digital systems and supporting technologies in preparation for commercial launch. Residing within the Patient Experience organization, the Cell Therapy Digital Platform group's goal is to create and operationalize a simple, accurate and streamlined global commercial experience for our externally-facing customers across their patient / provider CAR T journey with Celgene (referral to registry). This position will play a key supporting role in the analysis, development, and release of various technologies that will support Commercial Operations and Patient Operations and the systems they use including internal and external facing systems. The successful candidate will be responsible for mapping out business and system processes to align cross-functional and geographic teams on system requirements, and will also be involved in the planning and execution of digital systems outside of the US. Job Responsibilities: Learn and fully understand key business process and workflows that support the CAR T operations, including Commercial, Medical and Patient Operations teams, and be able to support and provide appropriate input and feedback for the development and enhancements of current and future technology needs Assist in the launch of solutions or systems to enable the launch of CAR T products and help maximize the positive impact on the organization Assure quality customer service to all internal Juno customers, promote positive service relationships and contribute to supportive and cooperative work environment Advocate for the technology needs of the business functions but also bring balance when necessary to achieve broader enterprise benefits Oversee and serve as primary point of contact and escalation for 3rd party cloud vendors and service providers Provide technical system input to the lifecycle management of systems, including any validation and ongoing change control Assist in writing and updating relevant documentation such as Standard Operating Procedures and Work Instructions Understand agile methodology and assist project teams with effective use of JIRA Required Qualifications: Bachelor's Degree in an IT, Business or Science discipline with at least 5+ years of experience working in the technology/healthcare area, preferably as a systems or business analyst Exposure to the development and launch of major e-systems Passionate about learning new technologies. Experience in writing and executing test scripts Excellent problem solving and process implementation skills Demonstrate ability to solve problems involving several options in situations. Requires intermediate analytical and quantitative skills. Experience in Agile software development Demonstrate excellent written and verbal communication Demonstrated success working in a high-performing, results-driven matrixed environment. Preferred Qualifications: Experience in Commercial Operations systems implementation Expertise with customer facing digital applications Prior experience implementing global systems Exposure to Salesforce.com platform 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
Jul 14, 2019
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 #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
Jul 13, 2019
Req #: Location: Summit, New Jersey, United States Job Category: Sales and Marketing Work Location: 86 Morris Avenue 07901 Organization: Channel Marketing Employee Status: Full-time Job Type: Regular Come Join Celgene's Organized Customer Marketing team! In this role, you will drive development and implementation of Celgene access strategies to support inline and launch performance across targeted Payer, PBM, & Provider System entities. This position will oversee the assessment, research, creation, and implementation of a strategy to establish a position for Celgene within these critical customer segments to ensure patient access across the portfolio. This position will work closely with the Head of Organized Customers, Access & Value Marketing, and Brand Marketing to develop and implement objectives tied to brand strategy and revenue forecasts. Responsibilities: Collaborate with Access & Value Marketing across Hematology/Oncology and Inflammation & Immunology to develop Payer, PBM, & Provider System strategies Identify key customer segments within Payer, PBM, & Provider Systems and pinpoint high-level customer needs to inform product value proposition development Identify impact and implications of organized customer trends including risks and mitigation strategies across in-line and launch products Communicate organized customer channel strategies and provide channel insights and expertise to inform contract strategy and brand planning across the portfolio Support implementation and continued assessment of strategy to drive inline and launch performance across internal & 3rd party pathways. Partner with the field on customer insight generation and supplement with external information and data to become expert in the organized customer groups Build trusting partnerships with account management and key Market Access leaders Establish key business metrics to measure success and execution Leverage customer insights to drive and guide the development of new platforms & customer partnerships Stakeholder Relationships Reports to Director, Organized Customer Marketing (Celgene Access Marketing) Interacts internally with team representatives from Brand Marketing, Health Economics and Outcomes Research, Market Research, Field Sales, Account Management, Analytics Ensures strong collaboration across functions to strengthen patient and organized customer value story and provides timely communication of insights to all relevant partners Direct working relationship with sales and analytics to create pull through strategy, messaging, and KPIs External relationships include interactions with managed markets customers across the Payer, PBM, & Provider System segments Required Skills/Experience: A bachelor's degree in related field. A minimum of 5 years of experience in any of the following areas: pricing, contracting, managed markets strategy, or value communication within payer and/or provider system marketing, national account management, consulting, and/ or market access strategy A minimum of three (3) years of experience in the pharmaceutical industry Strong understanding of the US payer environment, Payer, PBM, and Provider System market dynamics, payer marketing principles and how market access organizations and at-risk networks make decisions across private & public channels Strong interpersonal; communication; analytical and project management skills. Ability to access and influence various functional areas and motivate groups to action without direct line management responsibility Preferred Skills/Experience: MBA and/or advanced degree in scientific field (e.g., MPH, PharmD, PhD) highly preferred. Relevant experience may be substituted for advanced degree, when appropriate *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
Jul 11, 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. Remaining current with required GMP training and qualifications. Apply cGMP principles by following internal standard operating procedures (SOPs), work practices (WPs), and regulatory requirements. 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. Implement strategic plans for the kilo lab area, including operational enhancements, new equipment/capability purchase and installation, capacity expansion, etc.. Assist in developing and managing 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. 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 related to project activities. 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 or higher degree in Chemistry, Chemical Engineering, or closely related discipline, or relevant experience in lieu of degree. Minimum of 8 years experience in the pharmaceutical industry in small molecule drug substance development and facility 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, GMP/non-GMP manufacturing, 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
Jul 07, 2019
Full time
Req #: Location: Summit, New Jersey, United States Job Category: Market Access Work Location: 86 Morris Avenue 07901 Organization: Patient Support/Reimbursement Employee Status: Full-time Job Type: Regular The Associate Director, Patient Services Compliance will be responsible for overseeing day-to-day compliance-related issues for Patient Services, covering all brands at Celgene and coordinating with Celgene Legal and US Healthcare Compliance to provide strategic compliance guidance. This position will ensure that all areas of Patient Services operate compliantly within with U.S. federal and state laws and regulations related to the promotion, sale and marketing of Celgene's products and interactions with and payments to healthcare professionals; similar healthcare compliance requirements outside the United States; global anti-bribery/anti-corruption laws and Celgene policy. This leadership position within the Patient Services team will identify, collaborate on and implement creative solutions to Patient Support Compliance. This position oversees Compliance for all of Patient Services. Ideally, this position may have 1-3 direct reports. Responsibilities will include, but are not limited to, the following: Engaging with Legal and Healthcare Compliance Partners to identify risks and develop solutions and then lead the implementation of such solutions Remains informed of developments in applicable Compliance Rules and enforcement trends Strong subject matter expert and provides expertise and advice to business partners regarding Compliance issues Participates in and leads HCC Patient Support Audits/ inspections and/ or compliance projects and services with support from Legal and Compliance Drives planning, conduct, reporting, and follow-up with Patient Services Contributes to the development, implementation, and maintenance of Standard Operating Procedures Contributes information used in the development/approval of the annual risk assessment and audit plan Routinely suggests process improvements; questions norms and recommends change Skills/Knowledge Required: BS or BA required Strong business acumen, especially in the fields of PAP, Copay, Business Rules, ROE A minimum of 3+ years' experience in Patient Services or Compliance with a proven history of increasing responsibilities and accomplishment Broad knowledge of all relevant laws/regulations and deeper knowledge of relevant laws/ regulations in assigned disciplines Broad knowledge of all relevant Company policies/ procedures / standards with deeper knowledge of Company policies / procedures / standards in assigned disciplines Basic knowledge of assigned Celgene business units, processes, management systems, products services and technology Technically competent within job function Independent thinker Teamwork and collaboration skills, and ability to influence without authority Willingness and ability to identify and investigate areas of potential risk; healthy skepticism Demonstrate strong analytical competence Strong project management skills Exceptional oral presentation skills and written communication skills Strong organizational and multi-tasking skills Ability to use Microsoft Excel and PowerPoint Must be able to self-motivate and demonstrate leadership skills with the ability to perform effectively without supervision Key Internal/External Partners: Legal and Compliance Commercial Operations CPS External Hub Services vendors Sales Training & Market Access Training US Marketing Sales & Sales Leadership Market Access Senior Leadership All Relationships across US Market Access Pricing & Contracting Channel Marketing National Account Executives (Managed Care and Specialty) Finance Sales Operations All Patient Support/Reimbursement Vendors Celgene Leadership Competencies: Drive Innovation Shape Strategy Promotes Open Communication Demonstrate Adaptability Foster 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 Seattle, WA, USA
Jul 05, 2019
Full time
Req #: Location: Seattle, Washington, United States Job Category: Technical Development Work Location: 400 Dexter Ave N. 98109 Organization: Supply Chain Employee Status: Full-time Job Type: Regular Other Locations: United States-Florida-Miami, United States-Florida-Orlando, United States-Florida-Tampa, United States-Georgia-Atlanta, United States-North Carolina-Raleigh Patient Operations specializes in the supply chain functions that are unique to managing cellular therapy products. Our focus is on delivering timely, accurate and customer focused service to our customers. Our Patient Operations department has an opportunity for a Support Specialist to join the team supporting operations functions for the US Southeast region. Ideally, this position will be based in Seattle, however highly qualified remote candidates will be considered. Job Summary: The primary focus of the Apheresis Support Specialist role is to assist with the qualification, training, and management of the cell collection network. The Specialist will also be involved in site evaluations and on-going assessments of collection centers and Juno requirements. This is a critical role within the Patient Experience organization that requires someone with demonstrated experience working in a regulated environment, exceptional communication and organizations skills, as well as the flexibility to travel up to 50%. Job Description: Work with internal and external business partners to ensure cell collection centers successfully complete all qualification activities and are prepared to perform collections for Juno within the required timelines. Track qualification activities for assigned sites and communicate timeline delays to team. Work with manager to develop and execute mitigation plans for delayed timelines. Provide Quality Systems support by participating in deviation/change management activities and impact/investigation assessments for cell collection centers. Work with Quality Assurance and other internal business partners to monitor and assess vendor performance and capacity after site launch. Represent the department on cross-functional project teams, as requested. Comply with applicable SOP's and FDA regulations. Minimum Qualifications for Specialist, Apheresis Operations Support: Bachelor's degree; ideally in Life Sciences 3+ years of experience working in a regulated environment (e.g. GMP, GCP, GTP, Joint Commission, FACT, AABB) Ability to enjoy a high paced environment, meet deadlines, and prioritize work from multiple projects Ability to build effective relationships across company teams, and with external partners Strong teamwork skills and excellent customer service skills Accurate, responsive, and thorough communicator (both oral and written) Minimum Qualifications for Senior Specialist, Apheresis Operations Support: Bachelor's degree; ideally in Life Sciences 6+ years of experience working in a regulated environment (e.g. GMP, GCP, GTP, Joint Commission, FACT, AABB) Ability to enjoy a high paced environment, meet deadlines, and prioritize work from multiple projects Ability to build effective relationships across company teams, and with external partners Strong teamwork skills and excellent customer service skills Accurate, responsive, and thorough communicator (both oral and written) Preferred Qualifications: Knowledge of Apheresis and Good Tissue Practices Experience working in Cellular Therapy or Stem Cell Transplant programs Experience working with critical raw material suppliers or contract manufacturing organizations Experience in project coordination or management Experience with adult learning principles 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
Jul 05, 2019
Full time
Req #: Location: Seattle, Washington, United States Job Category: Technical Development Work Location: 400 Dexter Ave N. 98109 Organization: Supply Chain Employee Status: Full-time Job Type: Regular Other Locations: United States-Indiana-Indianapolis, United States-Ohio-Cleveland, United States-Ohio-Columbus Patient Operations specializes in the supply chain functions that are unique to managing cellular therapy products. Our focus is on delivering timely, accurate and customer focused service to our customers. Our Patient Operations department has an opportunity for a Support Specialist to join the team supporting operations functions for the Ohio Valley region. Ideally, this position will be based in Seattle, however highly qualified remote candidates will be considered. Job Summary: The primary focus of the Apheresis Support Specialist role is to assist with the qualification, training, and management of the cell collection network. The Specialist will also be involved in site evaluations and on-going assessments of collection centers and Juno requirements. This is a critical role within the Patient Experience organization that requires someone with demonstrated experience working in a regulated environment, exceptional communication and organizations skills, as well as the flexibility to travel up to 50%. Job Description: Work with internal and external business partners to ensure cell collection centers successfully complete all qualification activities and are prepared to perform collections for Juno within the required timelines. Track qualification activities for assigned sites and communicate timeline delays to team. Work with manager to develop and execute mitigation plans for delayed timelines. Provide Quality Systems support by participating in deviation/change management activities and impact/investigation assessments for cell collection centers. Work with Quality Assurance and other internal business partners to monitor and assess vendor performance and capacity after site launch. Represent the department on cross-functional project teams, as requested. Comply with applicable SOP's and FDA regulations. Minimum Qualifications for Specialist, Apheresis Operations Support: Bachelor's degree; ideally in Life Sciences 3+ years of experience working in a regulated environment (e.g. GMP, GCP, GTP, Joint Commission, FACT, AABB) Ability to enjoy a high paced environment, meet deadlines, and prioritize work from multiple projects Ability to build effective relationships across company teams, and with external partners Strong teamwork skills and excellent customer service skills Accurate, responsive, and thorough communicator (both oral and written) Minimum Qualifications for Senior Specialist, Apheresis Operations Support: Bachelor's degree; ideally in Life Sciences 6+ years of experience working in a regulated environment (e.g. GMP, GCP, GTP, Joint Commission, FACT, AABB) Ability to enjoy a high paced environment, meet deadlines, and prioritize work from multiple projects Ability to build effective relationships across company teams, and with external partners Strong teamwork skills and excellent customer service skills Accurate, responsive, and thorough communicator (both oral and written) Preferred Qualifications: Knowledge of Apheresis and Good Tissue Practices Experience working in Cellular Therapy or Stem Cell Transplant programs Experience working with critical raw material suppliers or contract manufacturing organizations Experience in project coordination or management Experience with adult learning principles 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
Jul 04, 2019
Full time
Req #: Location: Seattle, Washington, United States Job Category: Information Technology Work Location: 400 Dexter Ave N. 98109 Organization: Information Technology Employee Status: Full-time Job Type: Regular Other Locations: United States-California-San Francisco Juno, a Celgene company, is seeking a Business Analyst to support Cell Therapy Digital Platform in the analysis of digital systems and supporting technologies in preparation for commercial launch. Residing within the Patient Experience organization, the Cell Therapy Digital Platform group's goal is to create and operationalize a simple, accurate and streamlined global commercial experience for our externally-facing customers across their patient / provider CAR T journey with Celgene (referral to registry). This position will play a key supporting role in the analysis, development, and release of various technologies that will support Commercial Operations and Patient Operations and the systems they use including internal and external facing systems. The successful candidate will be responsible for mapping out business and system processes to align cross-functional and geographic teams on system requirements, and will also be involved in the planning and execution of digital systems outside of the US. Job Responsibilities: Learn and fully understand key business process and workflows that support the CAR T operations, including Commercial, Medical and Patient Operations teams, and be able to support and provide appropriate input and feedback for the development and enhancements of current and future technology needs Assist in the launch of solutions or systems to enable the launch of CAR T products and help maximize the positive impact on the organization Assure quality customer service to all internal Juno customers, promote positive service relationships and contribute to supportive and cooperative work environment Advocate for the technology needs of the business functions but also bring balance when necessary to achieve broader enterprise benefits Oversee and serve as primary point of contact and escalation for 3rd party cloud vendors and service providers Provide technical system input to the lifecycle management of systems, including any validation and ongoing change control Assist in writing and updating relevant documentation such as Standard Operating Procedures and Work Instructions Understand agile methodology and assist project teams with effective use of JIRA Required Qualifications: Bachelor's Degree in an IT, Business or Science discipline with at least 5+ years of experience working in the technology/healthcare area, preferably as a systems or business analyst Exposure to the development and launch of major e-systems Passionate about learning new technologies. Experience in writing and executing test scripts Excellent problem solving and process implementation skills Demonstrate ability to solve problems involving several options in situations. Requires intermediate analytical and quantitative skills. Experience in Agile software development Demonstrate excellent written and verbal communication Demonstrated success working in a high-performing, results-driven matrixed environment. Preferred Qualifications: Experience in Commercial Operations systems implementation Expertise with customer facing digital applications Prior experience implementing global systems Exposure to Salesforce.com platform 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.