Drug Product Lead

Role Overview

• Provide technical leadership to cross-functional teams during Drug Product development
• Lead and represent the Drug Product (DP) team for a late-stage development and/or a commercial product
• Drive Site Transfers to commercial DP manufacturing sites and process validation activities (Demo/PPQ)
• Represent manufacturing, CCS and Formulation aspects in the PDS&T CMC Team
• Develop, manage and drive execution of global initiatives to improve biologics CMC drug product development and commercial support strategies
• Create project level documents e.g. QTPP, Formulation Declaration, control strategy documentation
• Review and approve of GMP-compliant and regulatory documents (such as IMPD, IND, CTD for clinical trials, and BLA, NDA, PAS for market application submissions)
• Communicate actively project strategies, key issues, and risks to the PDS&T CMC
• Team, to functional management and SMEs

Requirements

• Pharmacist, Chemist, Biochemist, Biologist or comparable, preferably with PhD
• 8+ years of experience in relevant areas of parenteral Drug Product Development and/or commercial support
• Demonstrated track record of advancing complex parenteral drug product programs through late-stage development
• Strong experience leading technology transfer from R&D to Operations is highly desirable
• Extensive late-stage drug product development and commercial support experience is preferred
• Deep understanding of parenteral drug product development, including formulation, process development, manufacturability, and product lifecycle considerations
• Ability to lead multiple concurrent priorities in a fast-paced, collaborative environment
• Strong expertise in global CMC drug development, strategic planning, and project execution
• Experience supporting clinical and regulatory dossier preparation and market authorization submissions including IMPD, IND, CTD, BLA, NDA, and PAS
• Experience in a cGMP-regulated environment
• Solid knowledge of applicable international regulatory and quality requirements, particularly those in the US and EU
• Strong leadership capability with a proven ability to influence and collaborate effectively across direct and cross-functional teams in a matrix environment

Benefits

• flexible work models for a healthy work-life balance
• attractive salary
• intensive onboarding process with a mentor
• corporate health management offering comprehensive health and exercise programs
• company social benefits
• wide range of career opportunities in an international organization
• top-tier, attractive development opportunities
• strong international network