VP Of CMC

TL;DR

VP Of CMC (CMC): Own Chemistry, Manufacturing and Controls across the entire in-licensed biopharma portfolio, ensuring CMC oversight for drug substance and drug product through regulatory submission timelines. Focus on supplier/CDMO management, diligence and asset selection de-risking, and building expert KOL/consultant support for FDA and other agency interactions.

Location: Fully remote US or UK-based role

Company

Builds next-generation biopharma by in-licensing clinical-stage therapeutic assets and developing them using integrated, technology-first clinical trial infrastructure.

What you will do

• Own CMC oversight for every active asset (drug substance and drug product, analytics, stability, comparability, supply, quality, GMP ownership, QP release, and CMC sections of regulatory filings) to keep programs on time and on budget.
• Select, contract, and manage CDMOs, testing labs, and other suppliers against timelines, quality, and cost.
• Perform CMC diligence for inherited and in-licensed candidate assets: diagnose maturity, identify gaps/risks, and flag manufacturing complexity or cost that could impact asset economics.
• Build and manage a network of CMC KOLs and consultants and support clinical/regulatory colleagues on CMC content for FDA and other agency interactions.

Requirements

• 10+ years in CMC or pharmaceutical development, including the last 3–4 years owning CMC for one or more programs.
• Hands-on experience personally managing 3+ CDMOs/external manufacturing partners through clinical development-stage work (tech transfer, scale-up, and supply of drug substance and drug product for clinical trials), including selecting and contracting new CDMOs.
• Authored or led CMC sections (Module 3) for multiple INDs; ideally contributed to at least one NDA/BLA or major amendment.
• Experience prioritized at Phase I/II; small molecule and biologics experience preferred (covering both drug substance and drug product).
• Ability to operate without a direct-report team, delivering scope through external consultants, CDMOs, and KOLs.
• US or UK-based for a fully remote role.

Culture & Benefits

• Flexible engagement: full-time permanent or contract/fractional (minimum 2 days/week, with time varying around key submissions and deliverables).
• Competitive salary plus meaningful stock options; health insurance via PEO Trinet.
• 27 days annual leave plus 11 National Holidays; enhanced parental leave (16 weeks primary caregiver, 6 weeks secondary caregiver at full pay).
• $40 monthly wellness allowance and $2,000 annual learning & development allowance.
• Remote-team support including monthly lunch voucher and access to gym/retail discounts via benefits platform Happl.

Hiring process

• Initial conversation with Talent (45 minutes).
• Interview with CEO (30 minutes) and technical interview with Development team member (60 minutes).
• Values interview (30 minutes); contract candidates may have references earlier.