Clinical mAb Manufacturing Specialist - 1-Year Contract

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

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.