Vice President of CMC
New
L
Lindus HealthBiopharmaceuticals
This is a fully remote US or UK-based role.Full-TimeVp
SalaryCompetitive salary, plus meaningful stock options
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Job Details
- Experience
- 10+ years in CMC or pharmaceutical development
Requirements
- 10+ years in CMC or pharmaceutical development, with at least the last 3-4 in a role owning CMC for one or more programs.
- Personally managed 3+ CDMOs or external manufacturing partners through clinical development-stage work, including tech transfer, scale-up, and supply of drug substance and drug product for clinical trials.
- Owned the CMC content of regulatory submissions: authored or led the CMC sections (Module 3) for multiple INDs.
- Experience at Phase I and II clinical stages.
- CMC experience across more than one modality (small molecule and biologics preferred).
- Experience picking up assets from third parties and diagnosing the state, gaps, and risks of an inherited CMC package.
- Ability to manage scope and delivery entirely through external consultants, CDMOs, and KOLs.
- High agency and a bias for action.
Responsibilities
- Own CMC oversight across every active asset: drug substance and drug product, analytics, stability, comparability, supply, quality, GMP ownership, QP release, and the CMC sections of regulatory filings.
- Keep every program on time and on budget, and feed CMC realities into clinical development planning.
- Select, contract, and manage CDMOs, testing labs, and other suppliers, holding them to timelines, quality, and cost.
- Scope and de-risk the CMC of inherited and in-licensing candidate assets.
- Identify where formulation choices create protectable IP value.
- Build and manage a network of CMC KOLs and consultants.
- Support regulatory and clinical colleagues on CMC content for FDA and other agency interactions.
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