Specialist, QC Analytical, Cell Therapy

Bristol Myers Squibb • Summit, NJ

4d • $35 - $42

About The Position

Responsible for supporting quality control testing for in-process, final product, and stability samples, including data review and verification. The Specialist may assist with method transfer, documentation, deviations, investigations, and continuous improvement efforts. The position works Wednesday through Saturday, 1:30 p.m. to 11:30 p.m.

Requirements

• Ability to accurately and completely understand, follow, interpret, and apply global regulatory and cGMP requirements.
• Problem-solving ability and a technically adept, logical approach.
• Ability to communicate effectively with peers, department management, and cross-functional peers.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Bachelor's degree or equivalent required, preferably in science.
• At least 2 years of relevant analytical testing or QC experience, or an equivalent combination of education and experience; experience in a regulated environment is preferred.
• Demonstrated experience with cell and molecular biology techniques, such as cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique.
• Ability to lift up to 20 lbs (9 kg) at floor and waist height and up to 10 lbs (4.5 kg) overhead, and to push or maneuver carts.
• Ability to perform frequent pipetting and related laboratory tasks within a biological safety cabinet, including extended periods of seated work.
• Ability to independently don, doff, and wear required personal protective equipment for prolonged periods while performing laboratory work.
• Ability to safely handle chemical disinfectants, flammable materials, and hazardous chemicals; work may involve dry ice, liquid nitrogen, and cryogenically cooled materials.
• Ability to use step stools while reaching and handling materials and to work in a Biosafety Level 2 (BSL-2) environment.
• Must perform work safely in accordance with EHSS procedures, including risk control, proper PPE use, safe handling of chemicals and biological agents, compliance with waste and emergency procedures, and participation in training and safety programs.

Nice To Haves

• Knowledge of LIMS, ELN, and laboratory data analysis systems.
• Experience writing technical documents.
• Relevant analytical testing or QC experience in a regulated environment.

Responsibilities

• Perform routine testing of in-process, final product, and stability samples.
• Perform testing for method transfer, validation, and verification.
• Perform data verification and data review, and review GMP documentation for general methods.
• May perform document revisions and tasks related to projects, CAPA, deviations, investigations, and continuous improvement.
• Train analysts on general job duties.
• Perform other tasks as assigned.

Benefits

• Comprehensive benefits, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings.
• Non-exempt employees are offered 160 hours of paid vacation annually for new hires, subject to manager approval, 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, additional time-off benefits may include paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leave for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Additional discretionary incentive cash and stock opportunities may be available.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level