NIGHT SHIFT: Senior Manufacturing Associate, Cell Therapy in Devens, MA

Scorpion Therapeutics

Harvard (MA)

On-site

USD 46,000 - 56,000

Full time

11 days ago

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Benefits offered by this job

Health coverage
Wellbeing support
401(k)
Disability and life insurance
Paid time off
Additional leave options

Job summary

Scorpion Therapeutics in Devens, MA is seeking a dedicated bioprocess operator to join our GMP manufacturing team. You will perform aseptic operations, operate cleanrooms, and document batch records following SOPs to support cell therapy manufacturing.

This role requires 3+ years in cGMP bioprocessing, willingness to work 6pm–6am rotating shifts, holidays and weekends, and comfort with handling human blood components. On-site with comprehensive health coverage and retirement benefits.

Qualifications

  • High school diploma and 3+ years’ cGMP bioprocessing/manufacturing or cell therapy manufacturing/relevant experience.
  • Bachelor’s in relevant science/engineering strongly preferred.

Responsibilities

  • Execute operations per SOPs and batch records; complete required documentation (SOPs, batch records, validation/process transfer protocols)
  • Perform tasks consistent with safety policies, quality systems, and GMP/cGMP requirements
  • Complete training assignments; train others on SOPs and work instructions
  • Support investigations; solve simple problems using existing solutions; identify innovative solutions
  • Assist in setting up manufacturing areas/equipment/fixtures; perform facility/equipment commissioning activities
  • Write technically sound manufacturing operating procedures complying with cGMP
  • Work with production planning to execute daily unit operations schedule across shifts
  • Perform aseptic processing in a cleanroom; maintain environmental conditions via area disinfection to meet global Health Authority requirements

Skills

cGMP knowledge
Aseptic processing
Biologics/cell therapy manufacturing
Cleanroom work
Shift flexibility

Education

High school diploma
Bachelor’s in relevant science/engineering

Job description

Shifts Available
  • 6pm - 6am, rotating shift including holidays and weekends, onsite
Responsibilities
  • Execute operations per SOPs and batch records; complete required documentation (SOPs, batch records, validation/process transfer protocols)
  • Perform tasks consistent with safety policies, quality systems, and GMP/cGMP requirements
  • Complete training assignments; train others on SOPs and work instructions
  • Support investigations; solve simple problems using existing solutions; identify innovative solutions
  • Assist in setting up manufacturing areas/equipment/fixtures; perform facility/equipment commissioning activities
  • Write technically sound manufacturing operating procedures complying with cGMP
  • Work with production planning to execute daily unit operations schedule across shifts
  • Perform aseptic processing in a cleanroom; maintain environmental conditions via area disinfection to meet global Health Authority requirements
Knowledge & Skills (Required/Preferred)
  • Knowledge of cGMP regulations and FDA guidance for biologics/cell therapy manufacturing
  • Ability to work assigned shift (day/night/weekends/holidays)
  • Ability to work in cleanroom and perform aseptic processing; comfort with exposure to human blood components; close proximity to strong magnets
  • Experience in cell therapy manufacturing: cell washing/sep, cryopreservation (processes/equipment); preferred: ISO 5 aseptic processing in biosafety cabinets; BSL-2 universal precautions; cell expansion using incubators and single-use bioreactors
Basic Requirements
  • High school diploma and 3+ years’ cGMP bioprocessing/manufacturing or cell therapy manufacturing/relevant experience
  • Bachelor’s in relevant science/engineering strongly preferred
Compensation/Benefits (if applicable per posting)
  • Devens, MA: $33.51–$40.61/hour
  • Health coverage; wellbeing support; 401(k); disability and life insurance; paid time off; additional leave options (eligibility-based)
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