Principal Scientist, QC Analytical, Cell Therapy

Bristol Myers Squibb • Devens, MA

1d • Onsite

About The Position

Bristol Myers Squibb is seeking a Principal Scientist, QC Analytical, Cell Therapy. This role involves being a subject matter expert in bioanalytical techniques, leading method transfer/validation, and routine testing of samples. The scientist will conceptualize and lead complex projects, CAPAs, deviations, and continuous improvement efforts. They will also represent the department in product review boards, regulatory inspections, and author responses to regulatory requests, applying technical knowledge, regulatory requirements, and scientific principles to troubleshoot and solve complex problems. The work schedule is Monday through Friday with potential weekend and holiday support, though not routinely expected.

Requirements

• Bachelor’s degree or equivalent required, preferably in science.
• 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.
• 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.

Nice To Haves

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

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.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal