Downstream Process Associate

Client Job Title: Downstream Process Associate
Duration: 5 months
Location: San Diego, CA
Pay rate: $80-84/hr.

oin a growing Manufacturing team as a Downstream Pilot Plant Associate supporting the on-time delivery of quality gene therapy products. This role will participate in diverse activities including downstream process execution, maintaining GLP documentation, operating and maintaining process equipment, authoring records and procedures, and supporting continuous improvement efforts for viral vector gene therapy manufacturing.

• Perform downstream purification processes, including chromatography, ultrafiltration, tangential flow filtration, and depth filtration, at pilot and production scales.
• Operate and maintain standard bioprocessing equipment such as chromatography systems, ultracentrifuges, and tangential flow filtration (TFF) units.
• Adhere strictly to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in all activities.
• Prepare, review, and maintain batch records, SOPs, logbooks, raw material specifications, campaign summary reports, technology transfer documents, and presentations in compliance with regulatory requirements.
• Collaborate with cross-functional teams to support manufacturing investigations, root cause analysis, and process troubleshooting.
• Ensure compliance with SOPs, training requirements, and scale-up best practices.
• Maintain facility readiness and support regulatory inspections through vigilant oversight.
• Utilize Quality Systems and ERP platforms to document and track manufacturing activities.
• Drive process improvements through the change control process and other continuous improvement initiatives.
• Apply professional expertise to routine assignments; may supervise or serve as lead during on-floor activities.
• Provide process subject matter expertise and take ownership of assigned deliverables.
• Preferred: Experience conducting manufacturing investigations in biologics production.
• Demonstrate strong technical writing and communication skills.
• Maintain a safe working environment and stay current with all assigned training.

• Manufacturing support experience in bioprocessing required.
• Hands-on experience with chromatography, ultrafiltration, and depth filtration acquired through laboratory, pilot, or production-scale experience.
• Good Manufacturing Practices (GMP) experience required.
• Good Documentation Practices (GDP) experience required.
• Ability to effectively collaborate with team members and cross-functional partners.
• Experience with manufacturing investigations in biologics manufacturing.
• Familiarity with Quality Systems and Enterprise Resource Planning (ERP) systems.

Qualifications

• B.S. degree in Biology or a related field with 4-6 years of experience working in process development.