Bristol Myers Squibb
NIGHT SHIFT: Specialist, Lead Manufacturing Associate, Cell Therapy in Devens, M
Bristol Myers Squibb, Harvard, Massachusetts, us, 01451
NIGHT SHIFT: Specialist, Lead Manufacturing Associate, Cell Therapy – Devens, MA
Posted 1 week ago. Be among the first 25 applicants.
About the Role This role focuses on supporting routine manufacturing operations for cell therapy, ensuring safety, quality, and compliance with cGMP. The position is essential to maintaining efficient production during the night shift and requires strong problem‑solving and teamwork skills.
Shift Details Night Shift (6pm – 6am). Rotational schedule including holidays and weekends, onsite.
Responsibilities
Execute operations described in standard operating procedures and batch records.
Demonstrate strong practical and theoretical knowledge in their work.
Complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
Solve complex problems; take new perspectives using existing solutions.
Perform tasks in a manner consistent with safety policies, quality systems, and GMP requirements. Complete training assignments to ensure necessary technical skills and knowledge.
Set up manufacturing areas and equipment/fixtures; perform facility and equipment commissioning activities.
Collaborate with support groups on recommendations and solving technical problems.
Help ensure the shift works effectively in a team‑based, cross‑functional environment to complete all production tasks required by the shift schedule.
Collaborate closely with Shift Managers to ensure seamless pass‑down and communication of operational status.
Support investigations.
Identify innovative solutions.
Support writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
Train others on SOPs and work instructions to successfully complete manufacturing operations.
Work with production planning and leadership to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts.
Work in a cleanroom environment and perform aseptic processing; maintain 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.
Knowledge and Skills
Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
Ability to work assigned shift (Day, Night, Weekends and/or Holidays).
Experience working in a cleanroom environment and performing aseptic processing.
Comfortable being exposed to human blood components.
Experience working in close proximity to strong magnets.
Experience in cell therapy manufacturing, including cell washing processes and automated equipment, cell separation techniques, cryopreservation processes and equipment.
Preferred: Aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human‑derived materials in BSL‑2 containment areas.
Experience with cell expansion using incubators and single‑use bioreactors.
Basic Requirements
4+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience.
Bachelor’s in a relevant science or engineering discipline, or equivalent work experience.
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.
Personal protective equipment (PPE) and cleanroom garments must be worn daily, including safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.
Compensation Overview Devens, MA – US: $43.84 – $53.12 per hour. Additional incentive cash and stock opportunities may be available. Final compensation is determined by experience.
Benefits
Health Coverage: Medical, pharmacy, dental, and vision care.
Well‑being Support: BMS Well‑Being Account, BMS Living Life Better, Employee Assistance Programs (EAP).
Financial Well‑being and Protection: 401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Paid Time Off: US Exempt employees – unlimited flexible time off (with manager approval) and 11 paid national holidays. Non‑exempt hourly employees – 160 hours annual paid vacation, 11 national holidays, and 3 optional holidays. Additional unpaid time off may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs. All eligible employees may participate in the Global Shutdown between Christmas and New Years’ Day.
EEO and Accessibility Statement BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support. Applicants can request accommodations prior to accepting a job offer. For accommodations, contact adastaffingsupport@bms.com. For a complete Equal Employment Opportunity statement, visit careers.bms.com/eeo‑accessibility.
Candidate Rights BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Data Protection BMS will never request payments, financial information, or social security numbers during the application or recruitment process. Learn more about protecting yourself at careers.bms.com/fraud‑protection. All data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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About the Role This role focuses on supporting routine manufacturing operations for cell therapy, ensuring safety, quality, and compliance with cGMP. The position is essential to maintaining efficient production during the night shift and requires strong problem‑solving and teamwork skills.
Shift Details Night Shift (6pm – 6am). Rotational schedule including holidays and weekends, onsite.
Responsibilities
Execute operations described in standard operating procedures and batch records.
Demonstrate strong practical and theoretical knowledge in their work.
Complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
Solve complex problems; take new perspectives using existing solutions.
Perform tasks in a manner consistent with safety policies, quality systems, and GMP requirements. Complete training assignments to ensure necessary technical skills and knowledge.
Set up manufacturing areas and equipment/fixtures; perform facility and equipment commissioning activities.
Collaborate with support groups on recommendations and solving technical problems.
Help ensure the shift works effectively in a team‑based, cross‑functional environment to complete all production tasks required by the shift schedule.
Collaborate closely with Shift Managers to ensure seamless pass‑down and communication of operational status.
Support investigations.
Identify innovative solutions.
Support writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
Train others on SOPs and work instructions to successfully complete manufacturing operations.
Work with production planning and leadership to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts.
Work in a cleanroom environment and perform aseptic processing; maintain 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.
Knowledge and Skills
Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
Ability to work assigned shift (Day, Night, Weekends and/or Holidays).
Experience working in a cleanroom environment and performing aseptic processing.
Comfortable being exposed to human blood components.
Experience working in close proximity to strong magnets.
Experience in cell therapy manufacturing, including cell washing processes and automated equipment, cell separation techniques, cryopreservation processes and equipment.
Preferred: Aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human‑derived materials in BSL‑2 containment areas.
Experience with cell expansion using incubators and single‑use bioreactors.
Basic Requirements
4+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience.
Bachelor’s in a relevant science or engineering discipline, or equivalent work experience.
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.
Personal protective equipment (PPE) and cleanroom garments must be worn daily, including safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.
Compensation Overview Devens, MA – US: $43.84 – $53.12 per hour. Additional incentive cash and stock opportunities may be available. Final compensation is determined by experience.
Benefits
Health Coverage: Medical, pharmacy, dental, and vision care.
Well‑being Support: BMS Well‑Being Account, BMS Living Life Better, Employee Assistance Programs (EAP).
Financial Well‑being and Protection: 401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Paid Time Off: US Exempt employees – unlimited flexible time off (with manager approval) and 11 paid national holidays. Non‑exempt hourly employees – 160 hours annual paid vacation, 11 national holidays, and 3 optional holidays. Additional unpaid time off may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs. All eligible employees may participate in the Global Shutdown between Christmas and New Years’ Day.
EEO and Accessibility Statement BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support. Applicants can request accommodations prior to accepting a job offer. For accommodations, contact adastaffingsupport@bms.com. For a complete Equal Employment Opportunity statement, visit careers.bms.com/eeo‑accessibility.
Candidate Rights BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Data Protection BMS will never request payments, financial information, or social security numbers during the application or recruitment process. Learn more about protecting yourself at careers.bms.com/fraud‑protection. All data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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