Sr. Specialist, QC Microbiology (PCR, endotoxin and sterility)

Bristol Myers Squibb; Harvard (MA); On-site; USD 60,000 - 73,000; Full time

Job summary

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 products.

This role interfaces with multiple groups and requires independent task execution, interpretation of results, and troubleshooting.

Qualifications

• Bachelor’s degree required, preferably in Science.
• 4+ years of relevant work experience, preferably in a regulated environment.
• Experience in 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 understand and apply Global Regulatory and cGMP requirements.
• Strong technical writing skills and cross-functional communication.
• Working knowledge of LIMS and data analysis systems is desirable.

Responsibilities

• 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 proper laboratory equipment usage (Sterility, Bioburden, Endotoxin, Environmental monitoring).
• Anticipate and troubleshoot problems.
• Train new analysts and become a qualified trainer on assigned assays.
• Deliver training to analysts and document training per cGMP requirements.
• Support document revision, CAPA, investigations/deviation tasks.
• Perform tasks within CAPA, deviation, or project scopes.
• May lead projects and continuous improvement efforts.
• Other duties as assigned and may include shift coverage.

Skills

Strong written communication

Technical writing

Problem solving

Cross-functional collaboration

Detail oriented

Education

Bachelor’s degree

Tools

LIMS

Data analysis systems

PCR

Endotoxin testing

Sterility testing

Job description

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.

Job Summary

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.

Shift/Days/Hours

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

Job Responsibilities

• 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.

Qualifications And Education Requirements

• 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.

Compensation Overview

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.

Benefits

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time‑off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site‑essential, site‑by‑design, field‑based and remote‑by‑design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways‑of‑working.

Supporting People With Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud‑protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] the Job Title and Requisition number. Do not send application‑related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1605728 : Sr. Specialist, QC Microbiology (PCR, endotoxin and sterility)