Scientist/Manager Analytical Operations

Profile

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Juno Therapeutics, a **MEMBERS ONLY**SIGN UP NOW***., is developing clinical-stage, 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. The Cell Therapy Development Operations Department aims to drive operational innovation & excellence with assay / data automation solutions, critical material supply, equipment management, and quality & timely data to enable best-in-class and FAST to IND cell therapy development. We are looking for a strong team player and leader to join us to help achieve our goals.

Primary Responsibilities


Planning and overseeing critical reagent and critical raw material management program in support of P&AD activities across the entire portfolio. This may include inventory management, key stakeholder collaboration, strategic planning, and coordination between multiple sites and functions.
Serve as SME in the area of Bioassay and provide troubleshooting for junior scientist, leads method bridging and tech transfer effort.
Support the development of complete suite analytical method documentation such as protocols, development and qualification reports, standard operating procedures, QC test methods, and analytical sampling plans.
Lead and coordinate method and knowledge transfer activities across P&AD teams, streamlining the effort from method developers to Analytical Operations and Clinical QC groups. This will include close collaboration with multiple departments across sites.
Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of biotherapeutic products.
Enable automation for increased robustness and reproducibility of assays used to assess critical attributes of the process/product
Maintain accurate and detailed laboratory notebook and documentation.
Author technical and regulatory documents.


Basic Qualifications


M.S. or Ph.D. in a biological science discipline with 6 years of CMC development, Quality, and/or manufacturing experience.
Direct experience with analytical method development in the area of potency assay, process development, or product characterization.
In-depth knowledge of Operational Excellence and Lean Production Systems.
Familiarity with various assay development stages. Experience with assay qualification, method transfer, assay validation, new technology implementation, and lifecycle management.
Experience in QC and/or GMP manufacturing is a plus.
Experience in assay automation is desirable.
A strong team player with leadership skills. Experience with managing research associates as well as establishing/maintaining cross-department and/or external collaborations.
Exhibits Servant Leadership tendencies and nurtures the development and motivation of employees.
Strong time management skills with the capacity to meet deadlines and prioritize work from multiple projects.
Detail-orientated, organized, working knowledge of electronic notebook.
Experienced in good documentation practices including chain of custody, Laboratory Inventory Management Systems (LIMS), and Electronic Document Management Systems.
Excellent oral and written technical communication skills.
Strong sense of responsibility, accountability, passion, and integrity.


Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1527036_EN

Updated: 2020-07-14 00:00:00.000 UTC

Location: Seattle,Washington

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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