Production Specialist, Cell Therapy

Production Specialist, Cell Therapy at Insight Global Production Specialist, Cell Therapy at Insight Global in Berkeley, California Posted in 5 days ago.

Type:

full-time

Job Description:

The Role:

We are seeking a highly motivated Drug Product Specialist to join our growing Cell Therapy Manufacturing team. This critical role supports aseptic operations and ensures strict compliance with Good Manufacturing Practice (GMP) standards for drug product filling and finishing. The ideal candidate brings hands-on experience in aseptic techniques and a deep commitment to maintaining a sterile manufacturing environment.

Core Responsibilities:

Environmental Monitoring (EM): Perform routine and critical environmental monitoring in classified cleanroom areas (ISO 5/Grade A through Grade C) to ensure site compliance.

Aseptic Processing:

Execute aseptic drug product filling, capping, and visual inspection of finished vials.

Manufacturing Support:

Prepare solutions and buffers; manage inventory to ensure readiness for production runs.

Documentation:

Maintain and complete Electronic Batch Records (eBR) with high accuracy and adherence to Data Integrity principles.

Quality & Training:

Participate in gowning qualifications, aseptic training sessions, and media fill simulations.

Technical Operations:

Assist in routine manufacturing operations and troubleshoot equipment or process issues within GMP guidelines.

Collaboration:

Work closely with Quality Control, Quality Assurance, and Cross-Functional teams to ensure seamless production flow. [1, 2, 3]

Qualifications:

Experience:

2-3 years of experience in a regulated manufacturing environment (Biotech, Pharma, or advanced high-tech manufacturing).

Aseptic Proficiency:

Strong foundation in aseptic qualifications or formal aseptic training.

Technical Background:

Direct experience in drug product filling, visual inspection, or pharmaceutical compounding. Candidates from high-precision industries like silicon chip manufacturing with cleanroom experience are also encouraged to apply.

GMP Knowledge:

Deep understanding of Current Good Manufacturing Practices (cGMP) and sterile cleanroom operations.