Job Description

Downstream Pilot Plant Associate

Contract: 6 months with potential of extension and conversion to full time

Location: San Diego, CA

Schedule: 40 hours, fully onsite

Downstream Pilot Plant Associate Qualifications:

• 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 company 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 or other 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.

Downstream Pilot Plant Associate Responsibilities:

• B.S. degree in biology or related area with 4-6 years of experience working in process development or
• Manufacturing support in bioprocessing required
• Hands on experience with Chromatography, ultrafiltration and depth filtration process acquired through lab, pilot or production scale experience.
• Good manufacturing practices required
• Good documentation practices required
• Ability to effectively collaborate with team members
• Experience with manufacturing investigations for biologics manufacturing.
• Familiarity with Quality systems and Enterprise Resource Planning etc.

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