CMC AAV Director

COMPANY:

Our client is a clinical stage biotechnology company working on undertreated rare diseases through the development and commercialization of curative first-in-class gene therapies

LOCATION:

Cranbury, NJ

TITLE:

CMC AAV Director

ROLE RESPONSIBILITIES:

• Lead a small but growing team to support AAV pipeline
• Manage external contract manufacturing organizations (CMOs) and contract testing organizations (CTOs) for the manufacturing and timely release of AAV drug product
• Monitor the conformance of AAV drug product manufacturing to active batch records and regulatory filings
• Proactively manage conformance issues identified during and after GMP AAV drug product manufacturing

CANDIDATE REQUIREMENTS:

• A minimum of 7-8 years of AAV manufacturing experience or other similar viral vector platforms in the biopharmaceutical industry plus an advanced scientific degree (PhD, PharmD, or MS)
• Strong management experience (3-5 years)
• Previous experience with and expert knowledge of cGMP guidelines is essential

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.