Bioprocess Specialist - CONTRACT

GeneFab • Alameda, CA

77d • $40 - $50

About The Position

The Bioprocess Specialist II supports cell and gene therapy manufacturing at GeneFab by executing upstream and downstream processes in a GMP-compliant cleanroom environment. The role includes troubleshooting, deviation management, staff training, and participation in 5S and other improvement initiatives to support on-time delivery and right-first-time manufacturing batches. The specialist collaborates with Operations, MSAT, Quality, and Facilities teams to promote consistent production outcomes.

Requirements

• High school diploma or equivalent experience required.
• At least 3 years of experience in biotech or pharmaceutical manufacturing; 3–4 years is stated as the minimum experience range.
• Familiarity with cGMP standards and a basic understanding of Good Documentation Practices.
• Proficiency working in cGMP cleanrooms and with aseptic techniques.
• Advanced understanding of pipetting and micropipetting.
• Ability to work flexible hours, including nights and weekends, as schedules may shift.
• Ability to stand for extended periods and lift up to 20 pounds.
• Strong communication and teamwork skills, with a willingness to learn.

Nice To Haves

• Associate degree or higher in Biology, Life Science, or Engineering.
• Biotech or pharmaceutical manufacturing experience in a cleanroom environment.

Responsibilities

• Execute upstream and downstream manufacturing processes using aseptic techniques and manufacturing equipment in open and closed systems.
• Organize, coordinate, and lead production activities while ensuring processes are executed in accordance with cGMP standards.
• Complete batch records, forms, and other documentation accurately in line with Good Documentation Practices.
• Work as part of a team to support daily GMP manufacturing activities.
• Train staff in processing methods, aseptic technique, and cGMP cleanroom operations.
• Review batch production records for completeness, accuracy, and compliance with cGMPs and Good Documentation Practices.
• Initiate and support the closure of Deviation Reports and CAPAs.
• Contribute to 5S and other improvement initiatives, including identifying, challenging, and implementing potential improvements to work procedures.
• Perform other duties as assigned by management.

What This Job Offers

• Career Level: Mid Level
• Education Level: High school or GED