Pharma Manufacturing Technician - GMP Cleanroom, 12h Shifts

Insight Global; Berkeley (CA); Sur place; USD 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

HSA/FSA accounts

401k employer matching

Paid time off

Résumé du poste

Insight Global in Berkeley, CA is seeking a contract-based specialist for clinical manufacturing of monoclonal antibody drug substance. You will collaborate with BD and MSAT to ensure platform alignment and lead manufacturing steps from cell expansion to filling and inspection.

Candidate must have hands-on manufacturing experience on a GMP/GDP floor, familiarity with SAP, and be comfortable working in cleanrooms with full gowning.

Qualifications

• Hands-on manufacturing experience on a production floor.
• Experience with GMP processes and GDP compliance.
• Familiarity with SAP systems and handling 12-hour shifts.
• Experience working in cleanrooms with full gowning.
• Documentation tasks including BPRs, SOPs, and logbooks.

Responsabilités

• Responsible for clinical manufacturing of monoclonal antibody drug substance.
• Collaborates with BD and MSAT for new product introductions and platform alignment.
• Oversee all aspects of manufacturing: cell expansion, culture, differentiation, filling, inspection, solutions preparation and weigh/dispense.
• Maintain records and ensure data integrity; collaborate with QA and Production to meet targets.

Connaissances

Manufacturing Experience

GMP/GDP

SAP

12-hour shifts

Cleanrooms and gowning

Documentation (BPR/SOP/logbooks)

Outils

Batch Production Records (BPRs)

Description du poste

Insight Global in Berkeley, CA is seeking a contract-based specialist for clinical manufacturing of monoclonal antibody drug substance. You will collaborate with BD and MSAT to ensure platform alignment and lead manufacturing steps from cell expansion to filling and inspection.

Candidate must have hands-on manufacturing experience on a GMP/GDP floor, familiarity with SAP, and be comfortable working in cleanrooms with full gowning.