Technical Project & Product Lead – Drug Product (Oral Dosage) – 5752 ADA

 

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a Technical Project & Product Lead – Drug Product (Oral Dosage Form) for a 12-month contract (with high possibility of extension) in Basel, Switzerland.

 

This role is in the Drug Product / Combination Products Development & Manufacturing team of the client. You will be required to support and lead the drug product development of various oral products entering their clinical pipeline more especially for late-stage development and commercial oral dosage forms.

 

Main Responsibilities:

  • 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, scale-up, 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:

  • Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required.
  • Pharmacist or Equivalent with PhD Minimum of 15 years job relevant working experience in the pharmaceutical industry, especially with late-stage development (Phase 3) and/or Registration/process Validation/launch phase
  • Minimum of 10 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)

 

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