Senior Scientist - Principal Scientist Viral Vector Product amp Analytical Lead

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Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Senior Scientist - Principal Scientist, Viral Vector Product & Analytical Lead

Bristol Myers Squibb 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.

The Product & Analytical Development (P&AD) leadership seeks applicants for the Product and Analytical Lead role to drive strategy, knowledge, and deliverables related to lentiviral , AAV vector analytics development that are required for CMC program milestone achievement. The ideal candidate has a proven track record in matrix team leadership, CMC strategy, relationship-building with contract manufacturing organizations (CMOs) and contract test laboratories (CTLs), and a demonstrated skill set/knowledge of analytical development. This is a highly visible role that will serve as the P&AD single point of contact for program vector analytics strategy, for CMOs/CTLs, and across our partner organizations (Process Sciences & Technology, Quality, Regulatory, Program teams). The incumbent will be accountable for the analytical strategy that supports QC release, characterization, and in-process testing of vector used for CART /TCR gene delivery. The incumbent will lead a cross-functional team to deliver vector characterization and QC release assays, successfully transfer methods to CMOs and CTLs, and coordinate the qualification and validation thereof.

This position requires CMC strategy experience, project and cross-functional leadership skills, attention to scientific detail and ability to multitask in high-paced environment. If you have a passion for taking on new challenges in a fast-paced and dynamic environment, are dedicated to excellence and want to make a difference, we're excited to hear from you!

Job Description:


Lead the development of vector control strategy within a cross-functional team in support of engineered T cell programs. Establish phase appropriate analytical development, characterization, and release strategies related to LVV/AAV vector that is aligned across cellular therapeutics programs.
Manage CMO/CTL relationships to ensure development and qualification of appropriate analytical methods to enable vector process development, release and stability testing at CMOs/CTLs
Work with P&AD departments and cross functional partners to build vector process and product understanding that serves as the foundation of the analytical strategy including establishing and iterating QTPP, CQAs, and specifications throughout development.
Establish a flexible and agile matrixed P&AD team that supports both line function and program deliverables. Lead this team to ensure on-time CMC deliverables. Summarize and present data in cross-functional team meetings
Partner with process development partners and provide vector technical expertise required to support vector and drug product process development.
Contribute to regulatory submissions
Accountable for CMC analytical data- type, documentation, integrity, organization, and integration of datasets with cross functional partners
Champion for development needs and resource allocations. Develop and implement planning tools required for timely communication, efficient prioritization, and resource allocation.
Identify the opportunities for, and drive alignment of best practices in policy and strategy across P&AD departments areas to streamline practices and increase efficiencies


Basic Qualifications:


Principal Scientist: Ph.D. degree in virology, analytical sciences, or related field with 8 years of experience with CMC strategy and/or drug development
Senior Scientist: Ph.D. degree in virology, analytical sciences, or related field with 4 years of experience with CMC strategy and/or drug development
CMC team experience. Demonstrated knowledge of and analytical development and control strategy for CMC programs
Experience interfacing with GMP contract test laboratories and contract manufacturing organizations
Demonstrated experience in cross-functional and functional leadership roles. Demonstrated collaboration skills working cross functionally, maintain strong stakeholder relationships, influencing direction, voicing opinion, and communicating effectively.
Demonstrated method development experience in techniques such as viral safety and potency assays, viral titer assays, quantitative PCR (qPCR), ELISA, etc.
Experience authoring technical and regulatory documents. Experience in drafting, reviewing, approving, and supporting regulatory filings, including IND amendments, BLAs, and regulatory responses
Proficient in ICH, FDA, EMA, and JP regulations and guidance. Expertise in USP, EP, JP, etc. regulations and guidance

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.


PreferredQualifications:


Knowledge and experience with lentiviral and AAV biology
Experience with engineered T cells using viral modalities.
Track record of successful internal and external scientific collaborations.


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 the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1522801_EN

Updated: 2020-03-10 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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