Manufacturing Technician - Pharma

Insight Global; Berkeley (CA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

HSA, FSA, and DCFSA accounts

401k retirement account with employer

Paid sick leave and/or PTO as provided

Job summary

Insight Global seeks a Clinical Manufacturing Specialist for monoclonal antibody drug substance production. You will own all aspects of clinical manufacturing from cell culture and expansion to filling, QC, and documentation in a GMP environment.

Collaborate with BD and MSAT for new product introductions, maintain batch records, SOPs, and logbooks, and ensure GDP-compliant documentation. This role involves 12-hour shifts and work in a Class B cleanroom environment; competitive benefits apply.

Qualifications

• Hands-on experience on a manufacturing floor with exposure to downstream development.
• Experience with GMP processes, familiarity with SAP, and ability to handle 12-hour shifts.
• Experience working in cleanrooms and fully gowning.
• Experience with Batch Production Records (BPRs), SOPs and log books in GDP-compliant documentation.

Responsibilities

• Responsible for all aspects of clinical manufacturing in areas: Cell Expansion, Cell Culture, Differentiation, Filling, Visual Inspection, Solution Preparation and Weigh/Dispense.
• Cell Culture Maintenance: prepare and maintain cell culture environments, media prep, cell counting, growth monitoring.
• Quality Control: perform quality checks following protocols to prevent contamination.
• Data Recording: accurately record data on cell growth and production metrics.
• Collaboration: work with QA and Production teams to meet production targets.

Skills

Manufacturing Experience

GMP and GDP

Experience with cleanrooms

Documentation

Tools

SAP

Job description

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.