Tech Transfer Lead
Full-time
Technical Source
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 CDMOs
- Provide 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's
- 3–5+ 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*
Vacancy posted 9 hours ago
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