Director Drug Product

Darum lohnt es sich

This role will work closely with internal cross functional teams and external manufacturing partners to ensure successful clinical supply, regulatory filings and commercial launch activities.

This role will work closely with internal cross functional teams and external manufacturing partners to ensure successful clinical supply, regulatory filings and commercial launch activities.

Responsibilities Lead drug product development and manufacturing activities from clinical stages through commercialisation Develop and execute technical development plans, including formulation, process development and primary packaging strategies Drive process validation activities and establish validation strategies with external manufacturing partners Ensure uninterrupted clinical and commercial drug product supply Manage CDMOs and other external partners, including selection, contracting, performance management and business reviews Support regulatory submissions and filing strategies across global markets, including the US, EU and APAC regions Author technical reports and contribute to CMC documentation for regulatory filings Act as the subject matter expert for Manufacturing Science & Technology activities Support product quality reviews, lifecycle management and secondary packaging activities Evaluate and implement emerging technologies where appropriate Lead drug product project teams and coordinate cross functional technical activities Manage budgets, forecast spend and monitor financial commitments related to drug product activities Requirements PhD in Pharmaceutics, Pharmacy or a related scientific discipline 10+ years of experience within pharmaceutical development and/or GMP manufacturing environments Strong experience across the full drug product lifecycle, particularly late stage development, validation and commercialisation Expertise in oral solid dosage forms and/or sterile injectable products Deep understanding of formulation development, manufacturing processes and scale up activities Experience working with a broad range of dosage forms and associated analytical methodologies Strong knowledge of Quality by Design (QbD) and Quality Risk Management principles Proven track record managing CDMOs and external development/manufacturing partnerships Strong understanding of global regulatory requirements, including CTA and NDA submissions Experience supporting regulatory agency interactions Hybrid, Zug l Full-time l Permanent contract An innovative biopharmaceutical company is seeking a Drug Product Lead to oversee the development, validation, regulatory strategy and commercial manufacturing of drug products across the full lifecycle.

Director Drug Product An innovative biopharmaceutical company is seeking a Drug Product Lead to oversee the development, validation, regulatory strategy and commercial manufacturing of drug products across the full lifecycle.