Bristol Myers Squibb Company

Principal Scientist - Global Product Quality

Location
Seattle, WA, United States
Posted
Sep 07, 2020
Ref
R1526257
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 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 OR strong scientific in biologics/large molecule . 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.


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.