Barrington James · 9 hours ago
Vice President, CMC & Technical Operations
United States
Full-time
Remote
Director/Executive
12+ years expBarrington James is partnering with a Gene Therapy Biotech that is expanding its team in the US. They are seeking a hands-on VP CMC & Tech Ops to lead and execute all CMC and Technical Operations activities for its lead AAV gene therapy program entering IND-enabling development and first-in-human clinical trials.
Health CareRecruiting
Hiring Manager
Ryan Banton
Responsibilities
Develop and execute the overall CMC and Technical Operations strategy to support IND submission and Phase 1/2 clinical trials for AAV gene therapy programs
Serve as the company’s internal CMC subject matter expert, partnering closely with R&D, Clinical, Regulatory, and Executive Leadership
Build scalable CMC plans to support future pipeline expansion and later-stage development
Identify, select, and manage external CDMOs and vendors for viral vector manufacturing, testing, and fill/finish
Oversee tech transfer activities and ensure manufacturing execution aligns with regulatory and quality expectations
Manage timelines, budgets, and performance of all external partners
Own and author CMC sections of IND submissions, working closely with Regulatory Affairs
Ensure all CMC documentation meets FDA and global regulatory requirements
Partner with Quality to ensure GxP compliance across all CMC activities
Collaborate cross-functionally with Discovery, Translational, Clinical Ops, Regulatory, and Finance teams
Qualification
Required
Advanced degree in a relevant scientific discipline (Biology, Biochemistry, Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related field)
12+ years of experience in CMC and Technical Operations within biotech or pharma
Hands-on experience supporting IND-enabling development and early-stage clinical programs
Direct experience with AAV or viral vector gene therapy programs
Proven track record across the full CMC spectrum, including
Experience working in small, fast-paced startup or early-stage biotech environments
Demonstrated ability to operate both strategically and tactically (hands-on execution)
Strong decision-making ability with comfort owning outcomes and making executive-level technical calls
Experience managing multiple CDMOs and complex vendor networks
Exposure to global regulatory interactions (FDA, EMA)
Company
Barrington James
Barrington James has a true global reach, with its international HQ in London-Gatwick, continental hubs in Singapore.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Orangewood Partners
2022-10-05Private Equity
Recent News
2022-10-14
2022-10-06
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