Senior Associate, Cell Therapy Manufacturing
Vericel Corporation
July 02, 2026
On-site
Burlington, MA
Operations
Position Summary: Responsible for executing process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.
Position Scope / Responsibilities:
- Perform manufacturing procedures in a clean room per SOPs, cGMPs, and safety regulations.
- Perform aseptic manipulations of cell culture operations.
- Make cell-culture decisions based on observations and written procedures.
- Document all operations in Electronic Batch Records and log sheets per cGMPs/SOPs.
- Maintain inspection-ready controlled areas; sanitize clean room equipment.
- Record equipment/facility metrology; report out-of-spec readings to production management.
- Organize small groups/teams to deliver initiatives/projects; manage time and collaborate to meet daily manufacturing tasks.
- Work with rapport, accept feedback/coaching, and support standardization; assist/lead Team Leads.
- Follow safe work habits and safety procedures.
- Assist in reviewing/revising production documents (SOPs and electronic records).
- Identify/report deviations; lead GEMBA interviews and contribute to deviation investigations.
- If qualified in MACI or Epicel, cross-train and qualify in at least 5 core competencies (e.g., 3T3, Media Prep, D365 ERP, TrackWise, Veeva).
- Achieve/maintain Qualified Trainer status for at least 3 Operations.
- Serve as a technical resource and investigate manufacturing issues.
- Collaborate with Production Planners; communicate patient lot status to Customer Care.
- Other duties as assigned.
Qualifications (Basic):
- Bachelor’s (Life Sciences or related) or equivalent: 3+ years Vericel operations, or 4+ years in a cGMP biotech/pharma environment.
- HS Diploma/GED: 4+ years Vericel operations, or 5+ years cGMP biotech/pharma environment.
- Excellent written/verbal communication.
- Microsoft Office suite.
Qualifications (Preferred):
- Biotechnology certificate with hands-on lab courses.
- Experience in small-scale tissue culture processing.
- Experience in frequently audited regulated environments (e.g., FDA/ISO).
Position Scope / Responsibilities:
- Perform manufacturing procedures in a clean room per SOPs, cGMPs, and safety regulations.
- Perform aseptic manipulations of cell culture operations.
- Make cell-culture decisions based on observations and written procedures.
- Document all operations in Electronic Batch Records and log sheets per cGMPs/SOPs.
- Maintain inspection-ready controlled areas; sanitize clean room equipment.
- Record equipment/facility metrology; report out-of-spec readings to production management.
- Organize small groups/teams to deliver initiatives/projects; manage time and collaborate to meet daily manufacturing tasks.
- Work with rapport, accept feedback/coaching, and support standardization; assist/lead Team Leads.
- Follow safe work habits and safety procedures.
- Assist in reviewing/revising production documents (SOPs and electronic records).
- Identify/report deviations; lead GEMBA interviews and contribute to deviation investigations.
- If qualified in MACI or Epicel, cross-train and qualify in at least 5 core competencies (e.g., 3T3, Media Prep, D365 ERP, TrackWise, Veeva).
- Achieve/maintain Qualified Trainer status for at least 3 Operations.
- Serve as a technical resource and investigate manufacturing issues.
- Collaborate with Production Planners; communicate patient lot status to Customer Care.
- Other duties as assigned.
Qualifications (Basic):
- Bachelor’s (Life Sciences or related) or equivalent: 3+ years Vericel operations, or 4+ years in a cGMP biotech/pharma environment.
- HS Diploma/GED: 4+ years Vericel operations, or 5+ years cGMP biotech/pharma environment.
- Excellent written/verbal communication.
- Microsoft Office suite.
Qualifications (Preferred):
- Biotechnology certificate with hands-on lab courses.
- Experience in small-scale tissue culture processing.
- Experience in frequently audited regulated environments (e.g., FDA/ISO).