Tech Transfer Lead

Technical Source is currently in search of a Tech Transfer Lead for a gene therapy client in the Raleigh-Durham-Chapel Hill Area. This is a 6-month contract position. The qualified candidate should have extensive experience leading technology transfers for Drug Substance and Drug Product manufacturing processes, including upstream, downstream, and fill-finish operations. Responsibilities of the Tech Transfer Lead include: Lead Technology Transfers for AAV Drug Substance and Drug Product Manufacturing Develop and Review Tech Transfer Protocols, Risk Assessments, and Reports Coordinate with Process Development, Quality, and External CDMOsProvide Technical Oversight During Manufacturing Campaigns Manage Project Timelines, Milestones, and Technical Risks Qualifications of the Tech Transfer Lead include: Bachelor's or Master's Degree in Engineering, Virology, Biology, or a Related Field 10+ Years of Industry Experience with a Bachelor's OR 8+ Years with a Master's3–5+ Years Leading Technology Transfers or CMC Project Teams Experience with Upstream/Downstream Biologics and Aseptic Fill-Finish Manufacturing Strong Knowledge of cGMP, ICH Guidelines, and Deviation/CAPA Management Experience Working with External CDMOs*No C2C or Sponsorship is available at this time**Compensation will scale based on experience and fit*