Principal Scientist 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 Principal Scientist to provide quality oversight of Viral Vector methods in support of the Cellular Therapy product portfolio. This position will report into the Global Product Quality group. Successful candidates will have a strong foundation in viral vector GMP release assays (safety, titer, potency, etc.), transfer, validation and life-cycle management of test methods in a cGMP environment.

Responsibilities:


Function as the technical expert for viral vector methods at contract QC labs.
Function as the technical expert for transfer of methods from Development to Quality Control (QC) laboratories (internal and/or external contract test labs) and method validation in compliance with global regulatory requirements.
Responsible for the stewardship of viral vector methods in the Quality organization.
Implement method lifecycle and method maintenance programs to support viral vector methods used in the release of lentiviral and AAV vectors in support of cell therapy drug products.
Responsible for authoring relevant analytical sections of submissions, responding to health authority questions and function as the technical quality expert during inspections.
Partner with development organizations in the design of development and qualification studies, selection and characterization of reagents, and method optimization initiatives. Represent the Global Product Quality department on cross-functional project development teams.


Qualifications and Education Requirements


BS/MS in relevant scientific discipline and 10 years (or equivalent combination) experience within a regulated (GMP) biopharmaceutical, cellular therapy, or gene therapy organization. Experience in cellular therapies is preferred.
Strong scientific background and expertise with multiple viral vector analytical methodologies including those related to lentiviral and AAV vectors and other gene delivery platforms. Experience with culture-based viral safety assays is strongly preferred.
Experience in analytical method lifecycle, including method transfer, validation and maintenance. Experience providing training in method execution as well as instrument operation and standardization. Experience with implementing viral vector 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, cell therapies, vaccines and/or biological products.
Must possess effective time management skills, demonstrate initiative, resourcefulness and flexibility to work independently and as part of a team.
Strong technical writing experience (SOPs, Method Validation Protocols and Reports)is required.


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: R1526257_EN

Updated: 2020-06-11 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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