Associate I, Cell Therapy Manufacturing

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

Key Responsibilities
- Perform manufacturing procedures in a clean room following 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 (cGMP/SOP).
- Maintain inspection-ready controlled areas; sanitize clean room equipment.
- Record equipment/facility metrology data and report out-of-specification readings.
- Work independently; organize, plan, and manage time effectively; receive feedback.
- Collaborate in a team environment and follow safety procedures.
- Assist in reviewing/revising production documents (SOPs/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).

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.
- Microsoft Office suite experience.

Preferred Qualifications
- Biotechnology certificate with hands-on laboratory courses.
- Experience in small-scale tissue culture processing.
- Regulated-environment experience (e.g., FDA/ISO audits).