Position Summary
Responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.
Key Responsibilities
- Perform manufacturing procedures inside a clean room in accordance with 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 and SOPs.
- Maintain manufacturing-controlled areas in an inspection-ready state; perform clean room equipment sanitization.
- Record equipment and facility metrology data; report out-of-spec readings to production management.
- Work independently; organize, plan, and manage time to complete daily tasks; seek and apply feedback.
- Practice safe work habits and follow safety procedures.
- Assist in reviewing and revising production documents (SOPs and electronic records).
- Other duties as assigned.
Basic Qualifications
- Associateβs degree, or HS diploma/GED (or equivalent) with 0β1 years of experience in a cGMP biotech/pharmaceutical environment.
- Excellent written and verbal communication.
- Experience with Microsoft Office suite.
Preferred Qualifications
- Biotechnology certificate with hands-on laboratory coursework.
- Experience in small-scale tissue culture processing.
- Experience working in a regulated environment audited by agencies such as FDA and ISO.
Working Conditions & Physical Demands
- May sit for long periods; lift/carry/push/pull up to 50 lbs.
- Work one weekend day per week; rotating holiday coverage.
- Ability to gown and gain entry to manufacturing areas.