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.
Bristol Myers Squibb is seeking a Scientist for the Cellular Therapies Development and Operations (CTDO) organization who will support the quality oversight of NAT-based methods within the Cellular Therapy organization. This position will report into the Global Product Quality group. Successful candidates will have a strong foundation in molecular biology and demonstrated experience working in a cGMP environment.
Responsible for the stewardship of late-phase molecular biology methods in the Quality organization.
Implement method lifecycle and method maintenance programs to support molecular biology methods used in the release of cell therapy drug products and viral vector.
Responsible for transfer and validation of methods from Development to Quality Control (QC) laboratories in compliance with global regulatory requirements.
Support the authoring of relevant analytical sections of submissions, responding to health authority questions and representing the QC function during inspections.
Function as the molecular biology technical expert for QC labs during internal QC investigations and as the Quality liaison with contract test labs during QC investigations.
Partner with development organizations in the design of development and qualification studies, selection and characterization of reagents, and method optimization initiatives. Represent the QC department on cross-functional project development teams.
Qualifications and Education Requirements
BS/MS in relevant scientific discipline and 10+ years (or equivalent combination) experience in the development of molecular biology techniques.
Strong scientific background in standard molecular biology techniques (PCR/ddPCR/qPCR based methods, cloning, Western blotting) is required. Experience with viral vector characterization methods is required. Familiarity with NGS and Sanger sequencing is preferred.
Experience in analytical method lifecycle, including method transfer, validation and maintenance. Experience providing training in method execution as well as instrument operation. Experience with implementing molecular biology methods in a commercial QC facility is preferred.
Demonstrated ability to independently trouble-shoot molecular biology methods is required.
Experience in cGMP regulations and application within the Quality Control environment. Familiarity with FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of 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.