About The Position
As a Drug Product Lead you will lead and represent the Drug Product (DP) team for a product and you will be responsible for defining and executing the activities of drug product development, lifecycle management, and the technical-scientific support of the commercial production according to the latest state of science and technology, while considering regulatory requirements for the manufacturing of pharmaceuticals in parenteral drug product development.
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, with recognized technical depth and scientific leadership
- 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, with 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
Responsibilities
- Provide technical leadership to cross-functional teams during Drug Product development, commercial launch or trouble shooting of established processes and site transfers/scale-ups
- 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 as well as present complex technical topics to the development team and management
Benefits
- attractive salary
- intensive onboarding process
- mentor at your side
- flexible work models for a healthy work-life balance
- corporate health management that offers 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
