Director Drug Product

About the role

An innovative biopharmaceutical company is looking for a Drug Product Lead (Director Drug Product) to oversee the development, validation, regulatory strategy and commercial manufacturing of drug products across their full lifecycle. The role works closely with internal cross-functional teams and external manufacturing partners to ensure successful clinical supply, regulatory filings and commercial launch. It is a hybrid position based in Zug, full-time and permanent.

Key responsibilities

• Lead drug product development and manufacturing from clinical stages through commercialisation
• Develop and execute technical development plans, including formulation, process development and primary packaging strategies
• Drive process validation and set 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 the US, EU and APAC regions
• Author technical reports and contribute to CMC documentation for regulatory filings
• Act as 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

Required profile

• PhD in Pharmaceutics, Pharmacy or a related scientific discipline
• 10+ years of experience in pharmaceutical development and/or GMP manufacturing environments
• Strong experience across the full drug product lifecycle, especially late-stage development, validation and commercialisation
• Expertise in oral solid dosage forms and/or sterile injectable products
• Proven track record managing CDMOs and external development/manufacturing partnerships
• Eligible to work in Switzerland and the EU

Required skills

• Formulation development, manufacturing processes and scale-up activities
• Dosage forms and associated analytical methodologies
• Quality by Design (QbD) and Quality Risk Management
• Global regulatory requirements, including CTA and NDA submissions, and regulatory agency interactions