Process Development Associate

Core Duties

• Plan, prepare for and perform human clinical materials biomanufacturing campaigns typically as a verifier.
• Prepare final formulated cellular products for clinical trials within production timelines and manufacturing schedules.
• Plan and perform components of process development and technology transfer for manufacturing of clinical materials, scale-up/scale-out and optimization activities in transitioning and translating pre-clinical, benchtop research into phase appropriate clinical trials.
• Perform upstream and downstream components of assigned cGMP project(s).
• Identify, document and report operating excursions and facility deficiencies; make recommendations for process improvements and documentation improvements including Standard Operating Procedures (SOP) and manufacturing Batch Records (BR).
• Contribute to detailed manufacturing budget; including sourcing, identifying and ensuring qualified and verified raw materials for manufacturing; outlining overall and per/patient costs for project materials and supplies.
• Devise and revise methods and/or processes for SOP and Manufacturing Batch Records.
• Independently track, verify and ensure cGMP grade raw materials for biomanufacturing.
• Identify and plan for supply chain and raw materials lead times for scheduled campaigns.
• May prepare and submit abstracts or papers for publication in peer-reviewed journals and/or presentation at scientific conferences.
• Present results during internal meetings.

Desired Qualifications

• Experience with CAR T, TCR, T cells, gene editing, and cell therapy process development/manufacturing desired.
• Aseptic technique experience and cell culture preferred.
• cGMP experience is preferred.
• Knowledge and following SOPs and batch records preferred.