Upstream Process Development Contractor

LOCATION:

Greater Boston Area

TITLE:

Upstream Process Development Contractor

ROLE RESPONSIBILITIES:

• Act as the subject matter expert for AAV upstream process development
• Collaborate with CMO to support upstream activities during process development, preclinical, clinical and potentially commercial manufacturing
• Responsible for cell banking for both host cell and plasmid
• Design bioreactor, shake flask, iCellis, cell culture vessel studies for AAV upstream process development, characterization and performance qualification and define upstream process control strategies, comparability studies (if needed)
• Lead upstream activity support for technology transfers, scale up and scale down, manufacturing operations and deviations / investigations by designing and executing appropriate studies at CMO
• Independently design and execute experiments (DOE) to generate optimum and robust upstream processes

CANDIDATE REQUIREMENTS:

• Good understanding of scaling up and scaling down considerations for upstream processes
• In depth understanding and hand on experience in one or more of the following area is required: cell banking, plasmid, bioreactor, iCellis, CellStack, HyperStack, process modeling
• Demonstrated upstream subject matter expertise and hands-on upstream laboratory experience
• Good understanding of biopharma operations, GxPs, ICH guidelines, process characterization, and technology transfer

If you meet the requirements above and would like to be considered for this position, apply on-line now for immediate consideration and to be contact with further details.