Director Drug Product

headcount; Zug; Vor Ort; CHF 130.000 - 160.000; Vollzeit

Zusammenfassung

headcount is seeking a Director Drug Product in Zug to lead drug product development and oversee the entire lifecycle of drug products. The role involves managing external partners and ensuring compliance with global regulatory requirements. Candidates should have a PhD and over 10 years of relevant experience in pharmaceutical development.

This position offers a hybrid work model, allowing flexibility in the work environment while ensuring effective collaboration with cross-functional teams.

Qualifikationen

• PhD in Pharmaceutics, Pharmacy or a related scientific discipline.
• 10+ years of experience in pharmaceutical development and/or GMP manufacturing.
• Strong experience in drug product lifecycle, especially late stage development.

Aufgaben

• Lead drug product development and manufacturing from clinical to commercial.
• Develop technical development plans including formulation and primary packaging.
• Manage CDMOs and external partners, ensuring quality and timely supply.

Kenntnisse

Pharmaceutical development

GMP manufacturing

Formulation development

Project management

Regulatory submissions

CDMO management

Ausbildung

PhD in Pharmaceutics or related discipline

Jobbeschreibung

Director Drug Product

Hybrid, Zug Full-time 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. 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

Eligible to work in Switzerland and the EU.