(Fractional) Head of CMC

Our client is an early-stage biotech developing a proprietary nanoparticle platform for intranasal delivery of peptide therapeutics, initially focused on metabolic disease. The company is pursuing a differentiated strategy spanning both near-term commercial pathways and longer-term regulatory development. This hire will lead the CMC and manufacturing strategy needed to move the platform from preclinical stage through clinical supply and beyond. Job Summary This is a foundational leadership hire responsible for building and owning the manufacturing backbone of a novel drug delivery platform—from formulation and peptide API strategy through clinical supply, device integration, and external manufacturing partnerships. This individual will play a critical role in advancing development timelines, enabling future clinical milestones, and shaping long-term CMC strategy. Build a first-in-class drug delivery platform at the intersection of metabolic therapeutics and advanced nanoparticle science Own the CMC function end-to-end with meaningful influence on platform and company trajectory Work alongside scientific founders tackling complex formulation and delivery challenges Shape the manufacturing strategy behind a potentially transformative therapeutic platform Responsibilities Lead CDMO evaluation, selection, contract negotiation, and external manufacturing oversight Own formulation and process development, including tech transfer, scale-up, and GMP readiness Source and qualify peptide APIs while building a robust supply strategy Evaluate and advance intranasal device strategy, including testing and product compatibility considerations Establish critical quality attributes and analytical methods for nanoparticle characterization Build and manage supply chain strategy across development and commercial channels Support CMC components of regulatory filings and oversee clinical supply manufacturing for early studies Required Qualifications M.S. or PhD in Chemical Engineering, Pharmaceutical Sciences, Materials Science, or related field 10+ years of pharmaceutical CMC experience with increasing responsibility Direct experience with nanoparticle, microsphere, or complex formulation manufacturing Peptide API sourcing and supply chain management experience Experience with nasal or inhaled drug delivery systems Strong CDMO management background, including tech transfer and quality agreements Preferred Qualifications Prior CMC leadership within nasal/inhaled delivery or advanced formulation settings Experience with microfluidics-based nanoparticle manufacturing at scale Familiarity with compounding or alternative supply chain models a plus Prior seed/Series A biotech experience and comfort operating in lean, fast-moving environments This is a high-ownership opportunity for a CMC leader looking to help build a platform company from an early inflection point through clinical translation and scale. #J-18808-Ljbffr