Manager, Upstream Pilot Plant

Role: Manager, Upstream Pilot Plant in biopharmaceutical manufacturing, focusing on gene therapy product production. Responsibilities: execute upstream processes including cell culture, bioreactor operations (bench, pilot, and production scale), maintain GLP-compliant documentation, operate and support cell culture equipment, and contribute to process improvements. Ensure compliance with cGMP, GDP, and support facility readiness for inspections. Manage batch records, SOPs, and technology transfer documentation using Quality Systems and ERP tools. Provide process expertise and support investigations. Requirements: Bachelor’s in Biology, Chemical Engineering, or Biochemistry; 5+ years in upstream bioprocessing/manufacturing support; hands-on experience with mammalian or microbial cell culture, bioreactor operation, and media preparation. Knowledge of cGMP, GDP, and electronic documentation systems. Collaboration experience in cross-functional manufacturing or development teams. Preferred: Experience with biologics manufacturing investigations. High-Value: Focus on gene therapy (viral vectors), GMP manufacturing, cell culture processes, and process scale-up. Work setup: Full-time, in-person at San Diego, CA; minimal travel.