Leads strategy and execution for drug substance/product development, manufacturing (internal and external), supply chain and CMC-sections of regulatory filings, from early-clinical development through commercialization, ensuring quality and GMP compliance while managing teams, timelines, and external partners for reliable supply of R&D, clinical and commercial materials.
Key Responsibilities:
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Strategy & Leadership: Develop and implement overall CMC strategies, providing operational oversight, and guiding teams; translate R&D projects to manufacturing strategies.
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Manufacturing & Supply: Oversee (external) drug substance (API) and drug product manufacturing, scale-up and supply chain management, often with external partners.
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Regulatory Affairs: Lead the preparation and submission of CMC-sections for regulatory documents and interact with agencies.
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Quality & Compliance: Ensure all activities meet GMP quality standards and regulatory guidelines (FDA, EMA).
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Project Management: Manage CMC timelines, budgets, risks, and resources, ensuring timely delivery of R&D, clinical and commercial materials.
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Cross-functional Collaboration: Work closely with Research, Clinical, Regulatory, Quality, and Program and Project Management teams.
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Stakeholder Communication: Report progress and strategies to senior management and external partners.
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Technology Transfer: Supervises transfer of technology to commercial partners and suppliers.
Core Skills & Experience:
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Industry experience in CMC, GMP, and regulatory environments, preferentially with inhaled products.
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Leadership, negotiation, communication (written/verbal), and planning skills.
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Experience in process development, formulation, analytical methods, pharmaceutical development and stability studies.
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Experience in managing Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs).