Principal Scientist, Molecular Biology, Analytical Sciences & Technology (CTQ)

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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Position Summary:

BMS is seeking a Principal Scientist for the Cellular Therapies Development and Operations (CTDO) organization who will be responsible for the Quality oversight of Molecular Biology analytics in support of the Cellular Therapy product portfolio.  This position will report into the Analytical Science & Technology group. Successful candidates will have a strong foundation in molecular biology methods as well as a demonstrated experience working in a cGMP environment. 

Responsibilities:

• Responsible for the life-cycle management of commercial molecular biology assays in the Quality organization.

• Responsible for transfer and validation of methods in the commercial environment in compliance with global regulatory requirements.

• Implement method lifecycle and method maintenance programs to support molecular biology methods used in the release cell therapy drug products.

• Responsible for authoring 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 critical reagents, and method optimization initiatives. Represent the commercial QC function on cross-functional project development teams.

Qualifications & Experience:

• BS/MS in relevant scientific discipline and 7+ years experience designing and leading molecular biology method validations and method transfers is required. Experience in cellular therapies is preferred.

• Strong scientific background and expertise with molecular biology methods (relevant control strategies, extraction chemistries, qPCR, digital PCR, NGS) in the gene and/or cell therapy industry.

• Experience optimizing methods as required per commercial lifecycle management (method robustness, increased throughput, etc.).

• Must be able to function independently as the lead investigator and lead analytical investigations.

• Experience with implementing molecular biology methods in a commercial QC facility is required. Demonstrated experience in method lifecycle management in a commercial environment is desired. Experience training QC analysts in method execution and instrument operation and strong technical writing experience (SOPs, Method Validation Protocols and Reports) is required. Experience with implementation of automated platforms 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 biological products is required.

• 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.

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The starting compensation for this job is a range from $127,000-$159,000, plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. 

Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific ben