Senior Scientist, Clinical QC Bioanalytical

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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.

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.

Title: Senior Scientist, Clinical QC Bioanalytical

Location: Warren, NJ

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The Senior Scientist, Clinical QC Bioanalytical will be a subject matter expert supporting method transfer/validation and routine testing of in-process, final product, and stability samples. This individual will apply technical knowledge, regulatory requirements, and scientific principles to perform complex troubleshooting and problem solving. They will also be responsible for leading projects, document revisions, deviations/investigations/CAPA, and continuous improvement efforts.

Key Responsibilities:

• Subject matter expert supporting method transfer/validation and routine testing of in-process, final product, and stability samples.
• Apply technical knowledge, regulatory requirements, and scientific principles to perform troubleshooting and problem solving for nonroutine complex issues.
• Perform data verification, data review and review of GMP documentation for general and complex methods.
• Subject matter expert for training others on test methods and complex processes.
• 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). May author responses to regulatory requests.
• Lead project, CAPA and deviation/ investigation and/ or continuous improvement efforts.
• Train and mentor others on multiple complex QC test methods, processes, and procedures.
• Champion and foster a positive and successful collaborative quality culture.
• Perform other tasks as assigned.

Qualifications & Experience:

• Bachelor’s degree or equivalent required, preferably in science. Advanced degree preferred.
• 8+ years of relevant analytical testing, including 2+ years of QC experience, or an equivalent combination of education and experience.
• Advanced experience with various bioanalytical techniques (e.g., cell-based assays, ELISA, qPCR, flow cytometry) and scientific knowledge in the characterization, validation, and transfer of bioanalytical methods.

• Advanced ability to accurately and completely understand, follow, interpret and apply global regulatory and cGMP requirements.
• Demonstrated advanced technical writing skills.
• Advanced 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 complex projects.
• Advanced ability to communicate and collaborate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs, locally and globally.
• Demonstrated strategic thinking.
• Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills.

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