Production Specialist - Pharma

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

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

HSA/FSA

DCFSA

401k

Paid Time Off

Job summary

Insight Global is seeking a candidate for a 1-year contract to lead clinical manufacturing of monoclonal antibodies in our Cell Culture Technology Center. You will oversee cell culture, bioreactor operations, filling, and QC while ensuring GDP and GMP standards are met.

You will record data, maintain BPRs and logbooks, and collaborate with QA and production teams to hit timelines. Flexibility for schedule changes around surgeries is required.

Qualifications

• Hands-on experience on a manufacturing floor.
• Experience with GMP processes and GDP standards.

Responsibilities

• Responsible for clinical manufacturing of monoclonal antibodies (mAB) drug substance.
• Maintain cell culture environments and manage bioreactors/fermenters.
• Perform quality checks and record production data.
• Collaborate with QA and Production to meet targets.

Skills

Manufacturing Experience

GMP/GDP

Bioreactors

Clinical mAB manufacturing

Documentation

Deviation Handling

Job description

Duration: 1 year contract with extensions/ conversion

POSITION SUMMARY-

Responsible for clinical manufacturing of monoclonal antibodies (mAB) Drug substance within the Cell Culture Technology Center (CCTC). 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.
• Manage Bioreactors/ Fermenters
• 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 with Bioreactors/ Fermenters
• Experience with clinical manufacturing of monoclonal antibodies (mAB)
• Documentation: Experience with Batch Production Records (BPRs), SOPs, and log books, including:
• Experience with Batch Production Records (BPRs), SOPs, and log books.
• Ensure candidates know that if procedures aren’t followed, they are required to initiate and document deviations according to GDP standards.
• 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).
• Environmental Monitoring: Includes testing and monitoring on equipment.
• Use of LM2 Freezers: Liquid nitrogen freezers are required for freezing products prior to shipping.

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.