Drug Product Scientist (Temporary 8 months)

Switzerland
Posted 6 months ago

Key responsibilities

  • Lead all formulation, process and drug product development and supply aspects of projects for clinical and pre-clinical trials in coordination with the CMC and wider project teams in line with patients’ needs; define and implement Drug Product development and manufacturing strategies accordingly
  • Act as the main point of contact, manage, challenge and lead activities with external partners, including supplier selection, negotiating offers and contracts
  • Lead regulatory and control strategies for semi-finished products in line with Quality by Design principles, taking into consideration the status of the project, assessing technical risks, and ensuring their mitigation. Support the redaction of regulatory affairs documentation sections related to your area of expertise.
  • Propose and implement innovative formulation strategies based on a deep understanding of compound developability, drug delivery, innovative processes and technology providers
  • Establish and implement drug product development strategies (including Life Cycle Management)
  • Integrate, in the design of technical strategies, issues related to Intellectual Property and Freedom to Operate
  • Prepare and review key documents (development reports, protocols, batch records, etc.)

Your profile

  • Master’s degree in relevant scientific discipline (pharmaceutical engineering, etc), pharmacist or equivalent
  • At least 4 years industrial experience, working in hands-on formulation, drug product development roles in the pharmaceutical industry
  • Proven expertise in the field of pharmaceutical product development for oral solid dosages and, ideally, injectable products as well as supporting regulatory and quality guidelines.
  • Field experience in pharmaceutical product development and manufacturing at laboratory and pilot scales. Strong technical knowledge to design and manage process development and scale up studies.
  • Experience in process development with Quality by Design approach
  • Experience in managing contract development and manufacturing organizations (CDMOs)
  • Knowledge of radiopharmaceutical or biological drug development is a plus
  • Excellent knowledge of English
  • Good knowledge of standard IT tools
  • Ability to work as part of a team and effectively prioritise tasks
  • Highly motivated to deal with project challenges and lead innovation

Job Features

Job CategoryTECHNICAL R&D

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