Manufacturing Associate, Liso-cel CAR-T, Manufacturing Operations
Bristol Myers Squibb
13 hours ago
On-site
Summit, NJ
Operations
Shift Available:
- Wednesday–Saturday (with every other Wednesday off), Onsite Overnight Shift, 5:00 p.m.–5:30 a.m.
- Start/end times may change based on business needs.
Responsibilities:
- Execute Cell Therapy Manufacturing operations compliantly (cGMP in controlled, cGMP cleanroom).
- Follow Source Governing Documents (SOPs, Work Instructions, Batch Records, Forms).
- Perform transactions/process in electronic systems; adhere to business continuity processes.
- Prioritize safety; report safety events within 24 hours; escalate issues impacting compliance/safety.
- Complete documentation contemporaneously; perform work consistent with safety policies, quality systems, GMP requirements (including ALCOA+).
- Complete required training; verify training completion before GxP tasks.
- Execute daily unit operations schedule (people/product/material flow across shifts).
- Perform aseptic processing procedures (as assigned) and maintain environmental conditions via area disinfection.
- Improve manufacturing process technique and author technically sound, cGMP-compliant operating procedures.
Knowledge & Skills (preferred/required):
- Team collaboration and results orientation.
- Computer proficiency (word processing, spreadsheets, web apps).
- Detail-oriented and accountable; strong interpersonal skills.
- Basic cGMP understanding and FDA guidance applicable to biologics/cell therapy preferred.
Minimum Requirements:
- High School Diploma required; bachelor’s/associate degree preferred.
- 0–1 years experience in cGMP cell therapy manufacturing/bioprocessing (or relevant experience).
Working Conditions:
- Extended standing/walking; cleanroom aseptic work in ISO 5 cabinets with PPE.
- Lift/carry up to 30 lb; push/pull up to 50 lb; BSL2/ML1 handling human blood components.
- May work around strong magnets and vapor phase liquid nitrogen; assigned shifts including nights/weekends/holidays.
- Wednesday–Saturday (with every other Wednesday off), Onsite Overnight Shift, 5:00 p.m.–5:30 a.m.
- Start/end times may change based on business needs.
Responsibilities:
- Execute Cell Therapy Manufacturing operations compliantly (cGMP in controlled, cGMP cleanroom).
- Follow Source Governing Documents (SOPs, Work Instructions, Batch Records, Forms).
- Perform transactions/process in electronic systems; adhere to business continuity processes.
- Prioritize safety; report safety events within 24 hours; escalate issues impacting compliance/safety.
- Complete documentation contemporaneously; perform work consistent with safety policies, quality systems, GMP requirements (including ALCOA+).
- Complete required training; verify training completion before GxP tasks.
- Execute daily unit operations schedule (people/product/material flow across shifts).
- Perform aseptic processing procedures (as assigned) and maintain environmental conditions via area disinfection.
- Improve manufacturing process technique and author technically sound, cGMP-compliant operating procedures.
Knowledge & Skills (preferred/required):
- Team collaboration and results orientation.
- Computer proficiency (word processing, spreadsheets, web apps).
- Detail-oriented and accountable; strong interpersonal skills.
- Basic cGMP understanding and FDA guidance applicable to biologics/cell therapy preferred.
Minimum Requirements:
- High School Diploma required; bachelor’s/associate degree preferred.
- 0–1 years experience in cGMP cell therapy manufacturing/bioprocessing (or relevant experience).
Working Conditions:
- Extended standing/walking; cleanroom aseptic work in ISO 5 cabinets with PPE.
- Lift/carry up to 30 lb; push/pull up to 50 lb; BSL2/ML1 handling human blood components.
- May work around strong magnets and vapor phase liquid nitrogen; assigned shifts including nights/weekends/holidays.