Clinical Manufacturing Associate II, Cell Therapy in Devens, MA

Bristol Myers Squibb; Harvard (MA); On-site; USD 41,000 - 50,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible work options

On-site at Devens MA

Job summary

Bristol Myers Squibb in Devens, MA is seeking a Clinical Manufacturing Associate II, Cell Therapy to perform unit operations within cGMP guidelines and support startup activities for a new facility.

The role requires experience in cell therapy manufacturing, cleanroom operations, aseptic processing, and the ability to work day, night, weekends, and holidays. You will document batch records, follow SOPs, and collaborate across teams across multiple shifts.

Qualifications

• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.
• Willingness to work Day/Night/Weekends/Holidays as needed.
• Ability to work in a cleanroom and perform aseptic processing.
• Comfortable handling human blood components.
• Must travel to train and develop at other BMS sites.

Responsibilities

• Perform clinical patient process unit operations per SOPs and batch records.
• Maintain knowledge of process transfer protocols and QC requirements.
• Complete documentation per SOPs and batch records.
• Identify and implement innovative solutions to improve operations.
• Work in a cleanroom and maintain controlled environmental conditions.
• Assist in startup facility setup and equipment commissioning.
• Collaborate with support groups to solve technical and operational issues.

Skills

cGMP knowledge

Cell Therapy

Aseptic processing

Cleanroom

Documentation

Shift flexibility

Education

High school diploma

Bachelor's degree preferred

GMP compliance experience

Cell therapy manufacturing experience

Tools

ISO 5 biosafety cabinets

Bioreactors

Cryopreservation equipment

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 Clinical Manufacturing Associate II, Cell Therapy brings enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The Associate must be goal-oriented, flexible, and able to work efficiently with safety and quality in mind. The 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:

TBD

Responsibilities:

• Performing Clinical patient process unit operations and supporting operations described in standard operating procedures and batch records.
• Demonstrates 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
• Identifies 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.
• Referencing Batch Records, Standard Operating Procedures and Work Instructions to successfully complete manufacturing operations.
• Executing daily unit operations schedule that includes people, product, and material flow across multiple shifts.
• 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.
• Collaborating with support groups on recommendations and solving technical and operational problems.
• Assisting in setting up manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities.
• Any related tasks as required to contribute to a new startup facility.

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.

Knowledge and Skills:

• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.

• 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.

• Must be able to travel to train and develop at other BMS Sites. Travel durations typically a week or less.
  

Education and Experience:

• High school diploma and 2+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience
• Bachelors in relevant science or engineering discipline is 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.

BMSCART

#LI-ONSITE

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: $29.83 - $36.15per 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 workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries [e-mail]. Visitcareers.bms.com/eeo-accessibilityto 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.

R1606413 : Clinical Manufacturing Associate II, Cell Therapy in Devens, MA