Manufacturing Associate, CAR-T
Bristol Myers Squibb
6 days ago
On-site
Summit, NJ
Operations
Shift Available:
- Sunday–Wednesday (e/o Wednesday off); Onsite Day shift, 5:00 a.m.–5:30 p.m.
Responsibilities:
- Execute CAR-T manufacturing operations per Source Governing Documents (SOPs, work instructions, batch records, forms).
- Use electronic systems and follow business continuity processes.
- Follow safety, GMP, and quality requirements (including ALCOA+); report safety events within 24 hours and immediately escalate compliance/safety issues.
- Complete contemporaneous required documentation.
- Complete training before due dates; verify training completion prior to any GxP tasks.
- Perform aseptic processing in a controlled cleanroom environment (as assigned).
- Maintain environmental conditions via required area disinfection.
- Execute daily unit operations schedule (people/product/material flow).
- Improve manufacturing process techniques to reduce operational times.
- Author/maintain manufacturing operating procedures compliant with cGMP.
Knowledge & Skills:
- Knowledge of cGMP/FDA-regulated industry; general understanding of cGMPs.
- Basic math; technical writing; MS Office.
- Inventory control/management.
- Background understanding of biology, chemistry, medical/clinical practices.
Basic Requirements:
- Minimum high school diploma/equivalent; associate/bachelor’s in related field preferred.
- 0–1 year experience in cGMP cell therapy manufacturing/bioprocessing (or relevant education/experience).
Compensation Overview:
- Summit West (NJ): $27.83–$33.72 per hour (additional incentives/benefits may be available based on eligibility).
- Sunday–Wednesday (e/o Wednesday off); Onsite Day shift, 5:00 a.m.–5:30 p.m.
Responsibilities:
- Execute CAR-T manufacturing operations per Source Governing Documents (SOPs, work instructions, batch records, forms).
- Use electronic systems and follow business continuity processes.
- Follow safety, GMP, and quality requirements (including ALCOA+); report safety events within 24 hours and immediately escalate compliance/safety issues.
- Complete contemporaneous required documentation.
- Complete training before due dates; verify training completion prior to any GxP tasks.
- Perform aseptic processing in a controlled cleanroom environment (as assigned).
- Maintain environmental conditions via required area disinfection.
- Execute daily unit operations schedule (people/product/material flow).
- Improve manufacturing process techniques to reduce operational times.
- Author/maintain manufacturing operating procedures compliant with cGMP.
Knowledge & Skills:
- Knowledge of cGMP/FDA-regulated industry; general understanding of cGMPs.
- Basic math; technical writing; MS Office.
- Inventory control/management.
- Background understanding of biology, chemistry, medical/clinical practices.
Basic Requirements:
- Minimum high school diploma/equivalent; associate/bachelor’s in related field preferred.
- 0–1 year experience in cGMP cell therapy manufacturing/bioprocessing (or relevant education/experience).
Compensation Overview:
- Summit West (NJ): $27.83–$33.72 per hour (additional incentives/benefits may be available based on eligibility).