Senior Director, CMC – Small Molecules - Boston - Genepool Networks

    Genepool Networks
    Genepool Networks Boston

    1 day ago

    Pharmaceutical / Bio-tech
    Description

    Overview

    We are seeking a Senior Director, CMC to lead end‑to‑end Chemistry, Manufacturing, and Controls strategy for a growing small‑molecule pipeline. This role will own CMC from development candidate selection through INDs and Phase 1 clinical supply, working in a highly cross‑functional and externally partnered environment.

    Key Responsibilities

    • Lead CMC strategy from development candidate (DC) selection through GMP clinical supply for early clinical programs.
    • Provide hands‑on leadership across drug substance, drug product, analytical development, stability, and clinical supply readiness.
    • Guide formulation development to achieve target exposures and toxicology margins; ensure phase‑appropriate control strategies.
    • Oversee analytical method development/validation, reference standards, and stability programs in alignment with ICH Q1.
    • Manage clinical packaging, labeling, and supply chain readiness to support Phase 1 execution.
    • Serve as the CMC lead on cross‑functional program teams, proactively identifying and managing technical and regulatory risk.
    • Lead selection and governance of external partners (CDMOs, CROs, labs), including SOWs, budgets, timelines, quality, and performance.
    • Author and review CMC sections of regulatory submissions, including INDs and amendments, and support health authority interactions.
    • Build and mentor CMC capabilities as the organization scales.

    Qualifications

    • PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field (MS/BS with significant relevant experience considered).
    • 10+ years of increasing responsibility leading CMC for small‑molecule programs, with multiple INDs filed.
    • Demonstrated leadership across DS/DP, analytical, stability, and GMP clinical supply.
    • Strong track record of vendor governance and scientific/regulatory writing.
    • Strategic, pragmatic, and comfortable operating in fast‑paced environments.

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