Senior Clinical Manufacturing Associate, Cell Therapy Manufacturing

Bristol Myers Squibb; Harvard (MA); On-site; USD 46,000 - 56,000; Full time

Job summary

Bristol Myers Squibb, located in Devens, MA, seeks a Senior Clinical Manufacturing Associate to support clinical cell therapy manufacturing operations within a start-up facility. The role emphasizes GMP, quality systems, and collaboration to deliver innovative therapies.

The Senior Associate must be goal-oriented, flexible, and adept at aseptic processing in cleanrooms, with awareness of regulatory expectations and safety requirements. The position offers a dynamic, growth-oriented environment.

Qualifications

• High school diploma and 3+ years of cGMP bioprocessing or cell therapy experience.
• Bachelor's degree in science or engineering strongly preferred.
• GMP compliance knowledge, Data Integrity/ALCOA+ principles.
• Experience with aseptic processing in ISO 5 biosafety cabinets; handling human materials preferred.

Responsibilities

• Perform clinical patient process unit operations per SOPs and batch records.
• Document tasks per transfer protocols, validation protocols, and batch records.
• Maintain safety, quality systems and cGMP compliance in all operations.
• Assist in setting up manufacturing areas and equipment/fixtures; support commissioning.
• Support development of SOPs and daily production planning across shifts.
• Contribute to quality event investigations and continuous improvement.

Skills

Cell Therapy Operations

Shift flexibility

Cleanroom work

cGMP knowledge

Education

Bachelor's degree in science/engineering

High school diploma

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.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The Senior Clinical Manufacturing Associate brings enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The Senior Associate must be goal-oriented, flexible, and able to work efficiently with safety and quality in mind. The Senior Associate must be enthusiastic, and innovative individuals with a good understanding of good manufacturing practices to support Clinical Manufacturing Start Up activities, and direct manufacturing operations for Clinical Cell Therapy.

Shifts Available

6am – 6pm, rotating schedule including holidays and weekends

Responsibilities will include, but are not limited to the following:

• Performing Clinical patient process unit operations and supporting operations described in standard operating procedures and batch records.
• Demonstrating strong practical and theoretical knowledge of work
• Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
• Solving simple problems; taking new perspectives using existing solutions
• Identifying innovative solutions
• Performing tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
• Completing training assignments to ensure the necessary technical skills and knowledge.
• Working in a cleanroom environment and performing aseptic processing; maintaining manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.
• Referencing Batch Records, Standard Operating Procedures and Work Instructions to successfully complete manufacturing operations.
• Assisting in setting up manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities.
• Supporting development of manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
• Supporting production planning to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts.
• Supporting quality event investigations
• Any related tasks as required to contribute to a new startup facility.

Knowledge, Skills & Abilities

• Driven and motivated individual to learn and execute Cell Therapy Manufacturing operations.
• Must have the ability to work assigned shift (Day, Night, Weekends and/or Holidays).
• Must be able to work in a cleanroom environment and perform aseptic processing
• Must be comfortable working with human blood components.
• Must be able to be in close proximity to strong magnets.
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.
• Must be able to travel to train and develop at other BMS Sites. Travel durations typically a week or less.

Minimum Requirements

• High school diploma and 3+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience
• Bachelors in relevant science or engineering discipline is strongly preferred
• GMP Compliance experience, knowledge of Data Integrity and ALCOA+ principles, and direct application of them.
• Experience in cell therapy manufacturing, including cell washing processes, cell separation processes, cryopreservation processes, cell expansion processes using incubators and bioreactors, and automated equipment.
• Experience with aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human derived materials in BSL-2 containment areas is preferred.

Working Conditions

• Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time, throughout the day.
• Carrying weight, Pushing, Pulling Lifting - Required to carry, lift, push, and/or pull up to 50 pounds several times a day while handling production equipment and/or materials.
• Climb - Required to climb (use of stepladders in production areas, or stairwells) several times a day.
• Bend and Kneel - Required to bend or kneel several times a day.
• Overhead work - Required to perform overhead reaching during handling of production materials/files/supplies up to 25 pounds several times a day, throughout the day.
• Moving Head and Neck – Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day, throughout the day.
• Twisting - Required movement of twisting waist while setting up equipment several times a day, throughout the day.
• Repetitive Use - Required repetitive use of arms/wrists/hands while setting up equipment and processing several times a day, throughout the day.
• Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.

BMSCART

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview

Devens - MA - US: $33.51 - $40.61 per 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.

R1608353 : Senior Clinical Manufacturing Associate, Cell Therapy Manufacturing