Senior Specialist, Quality Control

Bristol Myers Squibb•Cambridge, MA

6d•$106,810 - $129,430•Onsite

About The Position

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.

Requirements

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 with 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.

Responsibilities

Serve as a Subject Matter Expert (SME) in the quality control group and work along with the analytical development team on method transfers from internal analytical team to external CDMO QC group.
Provide technical GMP lead for oversight of external release and stability testing, method transfer troubleshooting, assisting in critical reagent management, and execution of technical protocols.
Oversee method qualification and validation at CDMO QC laboratories.
Support stability data analysis and 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 the 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.

Benefits

Medical, pharmacy, dental, and vision care.
BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
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.
Flexible time off (unlimited, with manager approval) for US Exempt Employees.
11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees).
160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays for Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees.
Unlimited paid sick time (based on eligibility).
Up to 2 paid volunteer days per year (based on eligibility).
Summer hours flexibility (based on eligibility).
Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs.
Annual Global Shutdown between Christmas and New Years Day.