Principal Scientist, Analytical Science and Technology (ASAT), Cell Therapy

Bristol Myers Squibb • Devens, MA

6d • $124,590 - $155,211 • Hybrid

About The Position

The Principal Scientist is a highly experienced subject matter expert responsible for leading method optimization, transfer, and validation in support of Cell Therapy analytical portfolio. Conceptualize and lead complex projects, provides strategic scientific and technical input to the programs and projects. Apply technical knowledge, regulatory requirements, and scientific principles to independently perform complex troubleshooting and problem solving. The Principal Scientist balances deep hands-on laboratory involvement with cross-functional leadership, mentoring, and external scientific engagement.

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 matrix environment, meet deadlines, and prioritize work from multiple projects.
• Track record of scientific productivity as evidenced by publications, presentations, or equivalent internal contributions.
• Advanced ability to communicate and collaborate effectively with peers, senior management and cross-functional peers about task status, roadblocks and needs, locally and globally.
• Strong hands-on laboratory skill set, including execution, and interpretation of complex, high-impact scientific, multi-dimensional data in support of commercial QC analytical methods.
• Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills.
• Strong scientific background and expertise with various analytical methodologies including those related to lentiviral, AAV vectors and other gene delivery platforms.
• Ability to travel to support projects as needed.
• Bachelor’s/Master’s degree preferably in (bioanalytical) science.
• 10+ years of relevant experience in regulated cellular therapy or gene therapy, 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 lifecycle.
• Experience providing training in method execution as well as instrument operation and standardization.
• 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 viral vectors, cell therapies, vaccines and/or biological products.

Nice To Haves

• Advanced degree preferred.

Responsibilities

• Subject matter expert in Cell Biology and/or Molecular Biology, leads method technical investigation, method optimization/remediations, method transfer and method validation in compliance with regulatory requirements.
• Independently develop, write, and execute methods, protocols, reports, and other related documents aligned with regulatory and corporate guidelines.
• Conceptualize and independently lead complex projects, investigations, corrective actions and continuous improvement efforts. This includes the design and hands-on executions of laboratory experiments, evaluation of experimental data, identification of risks and impact.
• Represent the department in product review boards, regulatory inspections (internal and external audits).
• Own and author relevant analytical sections of regulatory submission and responses to health authority questions and requests.
• Implement method lifecycle and method maintenance programs to support methods in support of viral vector and cell therapy drug products.
• Partner with development organizations in the design of development and qualification studies, selection and characterization of reagents, and method optimization initiatives.
• Represent ASAT 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 non-routine 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
• Education Level: Associate degree