Senior Specialist, Quality Control

Position Summary

Bristol Myers Squibb at Kendall Square in Cambridge, MA is seeking a skilled QC specialist with GMP experience to join the Quality Control team to support the testing of novel RNA therapeutics. The successful candidate will help oversee external QC activities, assist with tech transfer to internal QC laboratories, and analyze internal routine testing samples.

• The person will serve as a subject matter expert (SME) in the quality control group and will work along with analytical development team on method transfers from internal analytical team to external CDMO QC group.
• Work streams include technical GMP lead for oversight of external release and stability testing, method transfer troubleshooting, assisting in critical reagent management, execution of technical protocols.
• Oversight of method qualification, validation at CDMO QC laboratories.
• Support stability data analysis along with stability document reviews.
• Maintain stability sample inventory and perform stability sample shipments to external contract laboratories and/or sample storage vendors, if needed.
• Work with QA group on datasheet review, QC investigation, out of specification (OOS), CAPA, Change Controls, and/or Deviation reports.
• Independently develop, author, revise, and execute SOPs, protocols, reports, and other related documents.
• Perform internal stability testing for RNA related testing samples and formulated drug product samples, including compendial methods along with biophysical testing such as particle size, LNP encapsulation, etc.
• Support routine analytical testing for research program needs, such as with chromatography‑based methods (HPLC) and/or biochemical assays such as ELISA assay.
• Prepare the data packet for review and peer‑review the data.

• Bachelor's degree required, preferably in a chemistry, life science, or related discipline with 5+ years relevant experience.
• Past experience with quality control, preferably with focus on stability.
• Hands‑on experience with at least one of the following analyses: mRNA, LNP, Potency assay, Flow Cytometry, PCR, ELISA, and/or HPLC is required.
• Good understanding of cGMP, GDP and GLP regulations and guidelines.
• General experience in data analysis and statistical evaluation/data trending.
• Scientific knowledge and direct experience with analytical method transfer processes.
• Advanced technical writing skills and problem‑solving ability.
• Ability to work independently in a high‑paced team environment, meet deadlines, and prioritize work from multiple projects.
• Communicate effectively with peers, and demonstrate collaboration across different functional groups.
• Detail‑oriented in assay execution and documentation.

Cambridge – MA – US: $106,810 – $129,430 (Full‑time employee). Additional incentive cash and stock opportunities may be available. Final compensation will be based on demonstrated experience.

• Health Coverage
  :
  Medical, pharmacy, dental and vision care.
• Well‑being Support
  :
  Programs such as BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs.
• 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.
• Paid Time Off:
  Flexible time off (unlimited), 11 paid national holidays, optional additional holidays for certain locations. Unlimited paid sick time and volunteer days, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and a global shutdown between Christmas and New Year’s Day.

Senior Specialist, Quality Control – BMS

Requisition Number: R1603884

Location:

Cambridge, MA

Bristol Myers Squibb is an equal‑opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.