Director, Process & Analytical Development - AAV

COMPANY:

Start-up, pre-clinical to clinical stage gene therapy company

LOCATION:

Cambridge, MA

RELOCATION ASSISTANCE:

Yes

TITLE:

Director, Process Development & Analytical Development - permanent, full-time

ROLE RESPONSIBILITIES:

This individual will oversee the gene therapy process development program and establish gene therapy manufacturing processes to support the company's pipeline. Other responsibilities include:

• Developing and mentoring the process and analytical development teams
• Design and execute strategy for developing the AAV manufacturing and analytical processes for gene therapy products
• Provide technical leadership and development of effective upstream and downstream processes and quality cGMP manufacturing
• Supporting regulatory strategy and activities, including authoring CMC documentation for regulatory filings

CANDIDATE REQUIREMENTS:

• MS or above required, PhD preferred with a minimum of 5 years of industry experience in gene therapy manufacturing with proven experience in AAV manufacturing and analytical development activities for both early and late stage development
• Good understanding of AAV development in a GMP environment
• Tech transfer experience
• Experience working and managing CMOs
• Understanding of analytical methods used to support process development and QC of viral vector products is required

If you meet the requirements above and would like to be considered for this position, apply on-line now to be contacted with further details. This is not a fully remote role.