GMP Bioprocess Specialist - Cleanroom Manufacturing

GeneFab; Alameda (CA); On-site; USD 55,104 - 68,880; Full time

Job summary

GeneFab's Bioprocess Specialist II plays a critical role in cell and gene therapy manufacturing, performing upstream and downstream steps in a GMP cleanroom. You will troubleshoot, manage deviations, train staff, and contribute to 5S and other improvement initiatives to ensure on-time delivery and right-first-time execution of batches.

You will collaborate with Operations, MSAT, Quality, and Facilities teams to ensure consistent production outcomes.

Qualifications

• Minimum high school diploma or equivalent; Associate or higher in Biology/Life Science/Engineering preferred.
• 3–4 years in biotech/pharma manufacturing, preferably in a cleanroom.
• Familiarity with cGMP and Good Documentation Practices.
• Proficient in aseptic techniques and pipetting.

Responsibilities

• Execute upstream and downstream manufacturing in a GMP cleanroom.
• Complete batch records and documentation per GDP.
• Lead production activities and ensure cGMP adherence.
• Train staff in processing methods and aseptic technique.
• Support deviation management and CAPA closures.
• Collaborate with Operations, MSAT, Quality, and Facilities.

Skills

Aseptic techniques

GMP compliance

Documentation practices

Teamwork and communication

Education

Associate or higher degree in Biology, Life Science, or Engineering

High School diploma

Job description

GeneFab's Bioprocess Specialist II plays a critical role in cell and gene therapy manufacturing, performing upstream and downstream steps in a GMP cleanroom. You will troubleshoot, manage deviations, train staff, and contribute to 5S and other improvement initiatives to ensure on-time delivery and right-first-time execution of batches.

You will collaborate with Operations, MSAT, Quality, and Facilities teams to ensure consistent production outcomes.