Sr. Specialist, QC Microbiology; PCR, endotoxin and sterility

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits.

This is work that transforms the lives of patients, and the careers of those who do it.

Bristol Myers Squibb is seeking a QC Senior Specialist for QC Microbiology at the Cell Therapy Facility (CTF) in Devens, MA. The QC Senior Specialist is responsible for supporting Quality Control microbiology testing for release of clinical and commercial cell therapy drug product. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot.

Additionally, the QC Senior Specialist will assist with training and assay transfer. The QC Senior Specialist role is stationed in Devens, MA.

The shift schedule for this position is Sunday to Wednesday 2:00 p.m. to 12:00 a.m.

• Perform compendial verification, method transfer/validation, and routine testing of in-process, final product, and stability samples.
• Use scientific principles to assist with microbiological testing methods and the proper use of laboratory equipment. ( Sterility, Bioburden, Endotoxin, Environmental monitoring)
• Anticipate and troubleshoot problems.
• Train new analysts to general job duties.
• Become a qualified trainer on assigned assays and deliver training to analysts, documenting training per procedural and cGMP requirements.
• Support document revision, project, CAPA, and investigation/deviation related tasks.
• Perform assigned tasks within a CAPA, deviation, or project.
• May lead projects and continuous improvement efforts.
• Other duties as assigned.
• Support for QC and manufacturing operations may include shift coverage consisting of on call, shift, and/or weekend coverage.

• Bachelor’s degree required, preferably in Science.
• 4+ years of relevant work experience, preferably in a regulated environment.
• An equivalent combination of education and experience may substitute.
• Experience working in a GMP laboratory, preferably with cell therapy products.
• Knowledge of aseptic technique within a laboratory environment.
• Hands on experience with various microbiology techniques including PCR, endotoxin and sterility testing.
• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Strong technical writing skills.
• Strong problem-solving ability/mentality, technically adept and logical.
• Ability to represent the interests of the group on cross-functional teams.
• Strong ability to communicate effectively with peers, department management and cross‑functional peers.
• Working knowledge of LIMS and data analysis systems is highly desirable.

Devens - MA - US: $43.84 - $53.12per hour

The starting pay range(s) listed above is for full‑time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws.

Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Subject to the…