About this role
At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits.
This is work that transforms the lives of patients, and the careers of those who do it.
Position Summary
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.
Duties/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.
Qualifications
Specific Knowledge, Skills, Abilities
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. Education/Experience/ Licenses/Certifications:
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.
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview
Devens - MA - US: $124,590 - $150,977