Senior Specialist, QC Analytical, Cell Therapy

About the Role

Responsible for supporting QC testing for in-process, final product, and stability samples, including data review/verification. Perform method troubleshooting, training, and transfer/validation. Execute document revisions, projects, deviations/investigations/CAPA, and continuous improvement efforts. This role is fully onsite with a schedule of Wednesday to Saturday, 1:30 PM to 11:30 PM ET.

Responsibilities

• Perform method transfer/validation and routine testing of in-process, final product, and stability samples.
• Anticipate and perform routine troubleshooting and problem solving with minimal guidance.
• Perform data verification, data review, and review of GMP documentation for general and complex methods.
• Perform document revision, project, CAPA, and deviation/investigation-related tasks and/or continuous improvement efforts.
• Train and mentor others on QC test methods, processes, and procedures.
• Perform other tasks as assigned.

Requirements

• Ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
• Demonstrated technical writing skills.
• High problem-solving ability/mentality, technically adept, and logical.
• Ability to communicate effectively with peers, department management, and cross-functional peers about task status, roadblocks, and needs.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Advanced knowledge of LIMS, ELN, and laboratory data analysis systems preferred.

Qualifications

• Bachelor's degree or equivalent required, preferably in science.
• 4+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
• Demonstrated experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique).

Benefits

Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs that provide employees with resources to pursue their goals, both at work and in their personal lives.

• 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:
  • 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).
  • 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.
  • Additional time off 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 Year’s Day.

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment.

Pay

Starting compensation range for this full-time role in Summit West, NJ, US: $40.97 - $49.64 per hour. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate considers required skills, job location, work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Schedule

Wednesday to Saturday, 1:30 PM to 11:30 PM ET.