Associate I, Cell Therapy Manufacturing

Position Summary
- Responsible for execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.

Key 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 operations in Electronic Batch Records and log sheets per cGMPs/SOPs.
- Maintain inspection-ready controlled areas; sanitize clean room equipment.
- Record equipment/facility metrology data; report out-of-spec readings.
- Work independently; organize, plan, and manage time; accept feedback.
- Collaborate in a team environment; follow safe work habits.
- Assist in reviewing/revising production documents (SOPs and electronic records).
- Identify/report deviations and contribute to deviation investigations.
- Cross-train and qualify in at least one core competency (e.g., 3T3, Media Prep, D365 ERP, TrackWise, Veeva).
- Other duties as assigned.

Basic Qualifications
- Bachelor’s degree (Life Sciences or related) with 0–2 years cGMP biotech/pharma experience OR HS diploma/GED with 2+ years cGMP experience.
- Excellent written and verbal communication.
- Experience with Microsoft Office suite.

Preferred Qualifications
- Biotechnology certificate with hands-on lab courses.
- Experience in small-scale tissue culture processing.
- Experience in regulated environments frequently audited (e.g., FDA, ISO).