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Technical Project Leader Drug Product
vor 3 Monaten
Technical Project Leader - Drug Product (5175 ADA)
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a
Technical
Project Leader Drug Product to join their late-stage development and commercial oral dosage forms and lead the drug product development of various oral products entering their clinical pipeline.
12-month contract, with potential extension, based in
Basel.
Main Responsibilities:
- The Project Leader Drug Product will lead the technical development of several oral solid dosage form products, from late phase development activities (Phase 3) up to commercialization, including formulation development and production scale up with external partners
- Lead and manage development, analysis and production of solid dosage forms, including clinical and market forms
- Ensure sufficient and timely supplies for development projects based on input from the Global Supply Chain, CMC, Project and/or Life Cycle management functions
- Lead the collaboration with external development partners with special emphasis on cost efficiency, timelines and scientific quality
- Lead the technical drug product development activities: plan, organize and administer the different aspects of the technical activities required for development, scaleup, validation and manufacturing of a drug from development (late stage
- Phase 3) up to commercial supplies
- Support the development, communication and execution of the overall CMC strategy
- Ensure compliance with regulatory guidelines
Qualifications and Experience:
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Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
- Pharmacist or equivalent with PhD Minimum of 10 years job relevant working experience in the pharmaceutical industry, especially with latestage development (Phase 3) and / or Registration/process Validation/launch phase
- Minimum of 5 years of leading of an interdisciplinary drug product team
- Scientific expertise in small molecule formulation development
- Scientific expertise in oral solid dosage forms
- Profound knowledge of GMP, quality control and pharmaceutical development and/or production processes, based on current guidelines
- Profound knowledge in QbD, DOE and QRM
- Ability to negotiate, plan, and coordinate technical development and manufacturing activities
- Excellent interpersonal skills with the ability to adapt effectively to rapidly changing organization issues, structures and dynamics
- Excellent English knowledge (oral and written)
