Bristol Myers Squibb Company

Sr. Manager, Global Product Quality

Location
Seattle, WA, United States
Posted
Sep 05, 2020
Ref
R1526221
Required Education
Bachelors Degree
Position Type
Full time
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.

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.
  • Strong scientific background in Viral Vector OR in biologics/large molecule
  • 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.


BMSCART

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.