CMC Lead
3 days ago
Hlx is currently conducting an exclusive CMC search for one of our gene therapy biotech partners in the US. If you are seeking your next challenge in CMC gene therapy, this opportunity could be the one for you Please see further details below.
Title: CMC Lead, Gene Therapies
Reporting to: SVP Technical Operations
Location: East Coast, up to 25% travel
The Role:
Our partner is expanding its CMC team to support commercial readiness for a late-stage product and to advance an early-stage candidate into clinical trials. They are seeking an experienced CMC leader to drive these transformative programs forward, with the ideal candidate having demonstrated experience in late-stage development through submission and launch, preferably in gene therapies. We will also consider applicants with a strong background in vaccines/biologics.
Duties and Responsibilities
- Lead CMC strategy and execution from pre-clinical development through commercialisation.
- Collaborate with Program Management to align CMC activities with overall objectives.
- Oversee cross-functional CMC activities, including process/analytical development and technology transfer.
- Ensure alignment with regulatory expectations and GMP standards.
- Manage CMC budgets and timelines, ensuring milestones are met.
- Partner with CDMOs to secure clinical and commercial supply readiness.
- Lead critical activities like process characterisation and PPQ campaigns.
Role Requirements
- Advanced degree in a relevant field (e.g., Biotechnology, Biochemistry, Chemistry).
- 6–8+ years of experience in CMC management (gene therapies preferred; biologics or vaccines considered).
- Proven expertise in late-stage development, regulatory submissions, and product launch.
- Strong leadership, problem-solving, and cross-functional collaboration skills.
- Familiarity with GMP regulations and biopharmaceutical manufacturing processes.
- Excellent communication and ability to work effectively in a global environment.
Please apply directly to find out more
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