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.
#J-18808-Ljbffr
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.
#J-18808-Ljbffr
