Senior Scientist, QC Analytical, Cell Therapy

Bristol Myers Squibb • Summit, NJ

12h • Onsite

About The Position

Bristol Myers Squibb is seeking a Senior Scientist, QC Analytical, Cell Therapy. This role involves being a subject matter expert supporting method transfer/validation and routine testing of in-process, final product, and stability samples. The position requires applying technical knowledge, regulatory requirements, and scientific principles to perform complex troubleshooting and problem-solving. The Senior Scientist will also lead projects, document revisions, deviations/investigations/CAPA, and continuous improvement efforts. Bristol Myers Squibb offers a work environment that values balance and flexibility, with a wide variety of competitive benefits, services, and programs designed to support employees' goals both professionally and personally.

Requirements

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

Nice To Haves

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

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 non-routine 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.

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: Senior