Manufacturing Technician - Pharma

Insight Global; Berkeley (CA); In loco; USD 90.000 - 120.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical insurance

Dental insurance

Vision insurance

HSA/FSA accounts

401k employer matching

Paid time off

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Manufacturing Experience

GMP/GDP

SAP

12-hour shifts

Cleanrooms and gowning

Documentation (BPR/SOP/logbooks)

Strumenti

Batch Production Records (BPRs)

Descrizione del lavoro

Duration: 1 year contract with extensions and conversions

POSITION SUMMARY-

Responsible for clinical manufacturing of monoclonal antibodies (mAB) Drug substance. Collaborates closely with biological development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensure platform alignment.

Responsible for all aspects of clinical manufacturing in the following areas: Cell Expansion, Cell Culture, Differentiation, Filling, Visual Inspection, Solution Preparation and Weigh/Dispense.

• Cell Culture Maintenance: Prepare and maintain cell culture environments, including media prep, cell counting, and growth monitoring.
• Quality Control: Perform quality checks, following strict protocols for contamination prevention.
• Data Recording: Accurately record data on cell growth and production metrics to ensure reliability.
• Collaboration: Work with Quality Assurance and Production teams to meet production targets

Skillsets:

• Manufacturing Experience: Hands-on experience working on a manufacturing floor ideally with exposure to downstream development processes.
• GMP and GDP: Experience with GMP processes, familiarity with SAP, and capability to handle 12-hour shifts
• Experience working in cleanrooms and fully gowning
• Documentation: Experience with Batch Production Records (BPRs), SOPs, and log books, including:
• Experience with Batch Production Records (BPRs), SOPs, and log books.
• Experience preparing labels, filling out documentation, and reviewing logbooks accurately in a GDP-compliant manner.

Work Schedule

• Regular Hours: 9 a.m. to 5 p.m.
• Flexibility: Two weeks before each scheduled surgery, shift times may change to ensure timely delivery to the hospital. Flexibility to adjust hours within a 40-hour week is required.
• Class B Workspace: All activities occur in a Class B space with a Biological Safety Cabinet (BSC).

Exact compensation may vary based on several factors, including skills, experience, and education.

• Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching.
• Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.