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Principal Scientist, Molecular Biology Cell Therapy at (BMS) Bristol-Myers Squibb in Summit, New Jersey

Posted in General Business 30+ days ago.

This job brought to you by eQuest

Type: Full-Time





Job Description:

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. 

Responsibilities:


  • 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.