Downstream Pilot Plant Associate

✨ Now Hiring: Process Development – Senior Associate / Downstream Pilot Plant Associate

📍 San Diego, CA (Onsite)

📅 6 months | Possible Extension

Join a rapidly growing biopharma team advancing next-generation gene therapy programs. We are seeking a Process Development – Senior Associate / Downstream Pilot Plant Associate to support critical manufacturing activities and help deliver high-quality viral vector gene therapy products.

🔬 Role Overview

As a key contributor within the Manufacturing organization, you will perform hands-on downstream processing, ensure compliance with GMP standards, support investigations, and help maintain operational readiness. This is an excellent opportunity for someone who thrives in a fast-paced, highly collaborative pilot-scale environment.

⭐ Key Responsibilities

• Execute downstream purification processes including chromatography, ultrafiltration, TFF, and depth filtration at pilot and production scale.
• Operate and maintain essential bioprocess equipment (chromatography systems, ultracentrifuges, TFF units).
• Ensure full compliance with cGMP and GDP in all operations.
• Prepare, review, and maintain batch records, SOPs, logbooks, raw material specifications, tech transfer documents, and campaign summaries.
• Partner with cross-functional teams on manufacturing investigations, root cause analysis, and process troubleshooting.
• Support regulatory readiness, facility compliance, and equipment operation.
• Utilize Quality Systems and ERP platforms for documentation and tracking.
• Contribute to process improvements and support change control initiatives.
• Provide subject matter expertise and lead/supervise on-floor activities as needed.

🎓 Qualifications

• B.S. in Biology or related discipline with 4–6 years of experience in process development or bioprocess manufacturing.
• Strong hands-on experience with downstream purification techniques (chromatography, UF/DF, depth filtration).
• Solid understanding of GMP and Good Documentation Practices.
• Experience with manufacturing investigations in biologics is preferred.
• Familiarity with Quality Systems, ERP tools, and regulatory documentation.
• Excellent collaboration, communication, and technical writing skills.

🚀 Why This Opportunity?

You’ll work on meaningful gene therapy manufacturing processes, collaborate with experts across the organization, and directly impact the development of life-changing therapies.

📨 Interested?

Apply now or reach out to learn more!