Downstream Process Development Contractor

LOCATION:

Greater Boston Area

TITLE:

Downstream Process Development Contractor

ROLE RESPONSIBILITIES:

• Act as the subject matter expert for AAV downstream process development
• Collaborate with CMO to support downstream activities during process development, preclinical, clinical and potentially commercial manufacturing
• Design chromatographic, centrifugation, filtration studies for AAV downstream process development, characterization and performance qualification and define downstream process control strategies, comparability studies (if needed)
• Lead downstream 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 purification processes

CANDIDATE REQUIREMENTS:

• Good understanding of scaling up and scaling down considerations for downstream processes
• In depth understanding and hand on experience in one or more of the following area is required: column and membrane chromatography (e.g. affinity, ion exchange), membrane filtration (NFF, TFF, viral filtration), centrifugation, viral clearance study, continuous processing, process modeling
• Demonstrated downstream subject matter expertise and hands-on downstream laboratory experience (e.g. AKTA chromatography and filtration systems)

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.