Specialist, Lead Clinical Manufacturing Associate, Cell Therapy

Shift: Wednesday – Saturday, 7am – 5pm.

Responsibilities

• Perform clinical patient process unit operations and support operations described in standard operating procedures and batch records.

• Demonstrate strong practical and theoretical knowledge of work.

• Complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.

• Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.

• Complete training assignments to ensure the necessary technical skills and knowledge.

• Work in a cleanroom environment and perform aseptic processing; maintain manufacturing environmental conditions (non‑viable particulate and viable microbial levels per controlled area classification specifications) by performing area disinfection as required to meet global health authority requirements.

• Reference batch records, standard operating procedures, and work instructions to successfully complete manufacturing operations.

• Solving complex problems; taking new perspectives using existing solutions.

• Identify innovative solutions.

• Set up manufacturing areas and equipment/fixtures; perform facility and equipment commissioning activities.

• Work closely with Manufacturing Managers to ensure a seamless pass.

• Work with production planning to execute the daily unit operations schedule that includes people, product, and material flow across multiple shifts.

• Help ensure the shift works effectively in a team‑based, cross‑functional environment to complete all production tasks required by the shift schedule.

• Collaborate with support groups on recommendations and solve technical and operational problems.

• Support the development of manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.

• Support quality event investigations.

• Perform any related tasks required to contribute to a new start‑up facility.

Knowledge, Skills & Abilities

• Driven and motivated individual to learn and execute cell therapy manufacturing operations.

• Must be able to work the 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

• 4+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing, or relevant experience.

• Bachelor’s degree in a relevant science or engineering discipline, or equivalent work experience.

• 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 while operating manufacturing/computer equipment for several hours at a time.

• Carry, lift, push, and/or pull up to 50 pounds several times a day while handling production equipment and/or materials.

• Climb using stepladders or stairwells several times a day.

• Bend or kneel several times a day.

• Perform overhead reaching during handling of production materials/files/supplies up to 25 pounds several times a day.

• Move head/neck while using computer applications and handling production equipment and materials several times a day.

• Twist waist while setting up equipment several times a day.

• Use arms, wrists, and hands repetitively while setting up equipment and processing several times a day.

• Wear personal protective equipment and clean room garments daily, including safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.

Compensation Overview

Devens - MA - US: $40.05 - $48.53 per hour. The starting compensation range(s) for this role are listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. Final, individual compensation will be decided based on demonstrated experience.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.

• Well‑being Support: Programs such as BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).

• Financial Well‑being and Protection: 401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio).

• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non‑Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.

Legal and EEO Statements

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. For assistance, contact adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights – BMS will consider for employment 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.

Job Requisition: R1603315: Specialist, Lead Clinical Manufacturing Associate, Cell Therapy.