Scientist, QC Microbiology, Cell Therapy

Biopharma Careers; Harvard (MA); On-site; USD 99,000 - 120,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible time off

Vacation and holidays

Job summary

Bristol Myers Squibb in Devens, MA is seeking a Scientist for QC Microbiology in Cell Therapy. You will expertly support method transfer/verification, perform routine testing of in-process and final products, and lead deviations/investigations with CAPA.

You will mentor staff and ensure GMP compliance across multiple methods and products. The role demands 6+ years of microbiology QC experience and strong technical writing, with opportunities for career growth in a collaborative, patient-focused

Qualifications

• Bachelor’s degree or equivalent required, preferably in science. Advanced degree preferred.
• 6+ years of relevant microbiological testing or QC experience or equivalent.
• Demonstrated experience with microbiological techniques.
• Ability to follow Global Regulatory and cGMP requirements.
• Demonstrated technical writing skills.
• Strong problem-solving ability and logical thinking.
• Excellent communication with peers and management.
• Ability to work in a fast-paced team and prioritize multiple projects.
• Knowledge of LIMS, ELN and lab data analysis systems is a plus.
• Strong mentoring and interpersonal skills.

Responsibilities

• Subject matter expert supporting method transfer/verification/validation and routine testing of in-process, final product, and stability samples.
• Review testing data packets, final lot files, COA reviews.
• Perform complex troubleshooting and independent problem solving.
• Review GMP documentation for multiple methods/products.
• Own CAPA and deviation/investigation tasks and continuous improvement.
• May represent the department in regulatory inspections.
• Train and mentor others on QC test methods and procedures.
• Cross-train on multiple complex microbiology methods and products.
• Write and revise technical documents such as test methods and SOPs.
• Perform other tasks as assigned.

Skills

Microbiology techniques

Technical writing

Communication

Problem solving

Education

Bachelor's degree or equivalent

Advanced degree preferred

Tools

LIMS

ELN

Laboratory data analysis

Job description

R1604513 : Scientist, QC Microbiology, Cell Therapy

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.

Position Summary

Subject matter expert supporting method transfer/validation and routine testing of in-process, final product, and stability samples. Perform data review/verification, complex troubleshooting, and method training. Own project, document revisions, deviations/investigations/CAPA, and continuous improvement efforts

Key Responsibilities

• Subject matter expert supporting method transfer/verification/ validation and routine testing of in-process, final product, and stability samples.


• Perform review of testing data (e.g., data packets, final lot file, COA review).


• Anticipate and perform complex troubleshooting and problem solving independently.


• Perform data verification, data review and review of GMP documentation for multiple methods (general and complex) and/or products.


• Own project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.


• May represent the department in regulatory inspections (internal and external audits).


• Train and mentor others on multiple QC test methods, processes and procedures.


• Cross trained on multiple complex microbiology methods and/or multiple products.


• Author and review/ revise technical documents such as test methods, SOPs, specifications, trend reports and/or sample plans as appropriate.


• Perform other tasks as assigned.

Qualifications & Experience

• Bachelor’s degree or equivalent required, preferably in science. Advanced degree preferred.


• 6+ years of relevant microbiological testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.


• Demonstrated experience with microbiological techniques.


• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.


• Demonstrated technical writing skills.


• High problem-solving ability/mentality, technically adept and logical.


• Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.


• Advanced ability to work in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects.


• Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred.


• Strong mentoring, coaching, influencing, negotiating and personnel interaction skills.

Compensation Overview:

Devens - MA - US: $99,380 - $120,428

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.

For roles based in Los Angeles County only:

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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] with 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.