Sr. Manager Viral Vectors - Global Product Quality

Profile

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.

The Cellular Therapies Development and Operations (CTDO) organization is seeking a Sr. Manager who will be responsible for the lifecycle management of Viral Vector methods at contract service providers. Reporting into the Global Product Quality group, this role is accountable for QC operations at contract testing sites, including coordination of method transfer and validation activities.

Responsibilities:


Responsible for viral vector testing at contract testing labs across a multi-product portfolio.

Manage a team of individual contributors who coordinate testing, including material management, test tracking, and CoA generation.

Liaise with internal technical experts and external labs to coordinate the transfer of methods to external testing labs.

Coordinate method validation activities at contract test sites.

Function as the Quality liaison with contract test labs during QC investigations.

Coordinate the implementation of method lifecycle and method maintenance programs to support viral vector methods used in the release of lentiviral and AAV vectors.

Represent the Global Product Quality department on cross-functional viral vector teams.


Qualifications and Education Requirements


BS/MS in relevant scientific discipline and 7 years (or equivalent combination) experience within a regulated (GMP) biopharmaceutical, cellular therapy, or gene therapy organization. Experience in management of external contract testing is preferred.

Strong knowledge of analytical method lifecycle, including assay qualification, transfer, validation and maintenance. Experience with implementing release methods in a commercial QC facility is preferred.

Experience in cGMP regulations and application within the Quality Control environment. Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of viral vectors, vaccines and/or biological products.





Demonstrated excellence in managing, mentoring, and developing staff of varying levels from Associate to Senior Scientist.





Strong technical writing experience (general QC lifecycle management procedures) is required. Excellent verbal and written communication skills and the ability to work effectively at a fast pace will be an asset.

Must possess effective time management skills, demonstrate initiative, resourcefulness and flexibility to work independently and as part of a team.


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.

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, disability or protected veteran status.

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