Principal Scientist, QC Analytical, Cell Therapy

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. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

Subject matter expert in bioanalytical techniques leading method
transfer/validation and routine testing of in-process, final product, and
stability samples. Conceptualize and lead complex projects, CAPAs,
deviations, and continuous improvement efforts. Represent department
in product review boards, regulatory inspections, and author responses
to regulatory requests. Apply technical knowledge, regulatory
requirements, and scientific principles to independently perform
complex troubleshooting and problem solving.

Work Schedule:

Monday through Friday with weekend and holiday support if required but not routinely expected

Duties and responsibilities:

• Subject matter expert in bioanalytical techniques (e.g., cell-based assays, ELISA, qPCR, flow cytometry) leading method transfer/validation and routine testing of in-process, final product, and stability samples.

• SME for training and mentoring team on multiple complex QC test methods, processes, and procedures.

• Independently develop, write, and execute methods, protocols, reports, and other related documents aligned with regulatory and corporate guidelines. Represent the department in product review boards, regulatory inspections (internal and external audits).

• Own and author responses to regulatory requests.

• Review and approve laboratory investigations.

• Champion and foster a positive and successful collaborative quality culture. Conceptualize and lead complex projects, CAPAs, deviations, and continuous improvement efforts.

• Own sections of APQR.

• Represent QC interest on cross functional/ cross-site teams and communicate and collaborate effectively.

• Apply technical knowledge, regulatory requirements, and scientific principles to perform troubleshooting and problem solving for nonroutine complex issues. Perform other tasks as assigned

Education and Experience:

• Bachelor’s degree or equivalent required, preferably in science. Advanced degree preferred. Netherlands: PhD in (bioanalytical) science preferred. Bachelor's degree in (bioanalytical) science with equivalent combination of work experience may be considered.

• 10+ years of relevant analytical testing, including 2+ years of QC experience, or an equivalent combination of education and experience.

• Expert scientific knowledge with a broad range of bioanalytical techniques (cell-based assays, ELISA, qPCR, flow cytometry) and deep expertise with the characterization, validation, and transfer of bioanalytical methods.

Required Knowledge and skills:

• Advanced ability to accurately and completely understand, follow, interpret and apply global regulatory and cGMP requirements.

• Demonstrated advanced technical writing skills.

• Advanced strategic thinking and problem-solving ability/mentality, technically adept and logical.

• Ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects.

• Advanced ability to communicate and collaborate effectively with peers, senior management and cross-functional peers about task status, roadblocks and needs, locally and globally.

• Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills.

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview:

Devens - MA - US: $124,590 - $150