Senior Director, Formulation & Drug Product Development
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De functie
Lead formulation strategy and execution across multiple small-molecule programs from preclinical to late-stage, ensuring scalable, high-quality drug products.
Define specifications, control strategies, and robust manufacturing processes in alignment with global regulatory and quality expectations.
Drive pre-formulation, formulation and process development, optimization, scale-up, clinical manufacturing, and technology transfer to CDMOs.
Partner with Drug Substance, analytical development, regulatory, and QA teams to support validation, PPQ readiness, and regulatory filings.
Provide CMC input for global regulatory submissions and health authority interactions; facilitate transition to commercial-scale operations.
Lead, mentor, and develop a high-performing team; manage global vendors and oversee travel up to 35%.
Define specifications, control strategies, and robust manufacturing processes in alignment with global regulatory and quality expectations.
Drive pre-formulation, formulation and process development, optimization, scale-up, clinical manufacturing, and technology transfer to CDMOs.
Partner with Drug Substance, analytical development, regulatory, and QA teams to support validation, PPQ readiness, and regulatory filings.
Provide CMC input for global regulatory submissions and health authority interactions; facilitate transition to commercial-scale operations.
Lead, mentor, and develop a high-performing team; manage global vendors and oversee travel up to 35%.
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