Senior Director, CMC Lead Product Development
Scorpion Therapeutics
Responsibilities Represent CMC (DS, DP, Analytical) in governance forums; advocate for the CMC team; ensure transparent governance, bi-directional communication, cross-functional ownership, and proactive risk mitigation. Lead cross‑functional CMC product development team meetings; ensure information flow between CMC and program/portfolio governance forums. Critically evaluate and integrate raw materials, drug substance, and drug product inputs into development strategies aligned with corporate objectives. Lead and manage one or more CMC project teams; contribute to portfolio prioritization; negotiate for resources; influence timelines to ensure required activities are completed. Mentor functional representatives; provide feedback to functional managers; identify team members’ growth needs. Lead and execute fully integrated product development strategy supporting clinical trials and regulatory approval. Support and contribute to the GSC&TO Program Management framework, including continuous improvement of the CMC Development Roadmap and Governance. Serve as CMC Lead for high‑profile partnerships/collaborations and Joint Development Committee decision‑making. Communicate plans and risks to senior leadership through regular updates and periodic reviews in support of global filings and approvals. Lead and execute in alignment with ICH and applicable regulatory requirements. Qualifications Ph.D. in Chemistry/Pharmaceutical Sciences/Engineering or related field with 10+ years of development (drug substance, drug product, and/or analytical); or M.S. with 15+ years of relevant CMC experience. Skills/experience: small molecule API and formulation/analytical development; effective verbal communication; strong knowledge of technical regulatory requirements/trends (ICH/FDA/EMA/MHRA); project/program management, governance, and risk management. Preferred/desired: experience leading a CMC team through IND and NDA/MAA; strong scientific writing; CMC interdisciplinary expertise in oral solid, small molecule space; enterprise thinking; experience across various modalities. #J-18808-Ljbffr Scorpion Therapeutics
$157.59k - $203.94k
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