Expert In Drug Product Formulation And Processing For Synthetic Molecule Parenterals (cmc Advisor)

Roche UK

Basel, Switzerland
Peptide parenteral formulations
Synthetic molecule parenterals
Formulation and manufacturing process development
The Pharmaceutical Development DP SM Parenterals group is responsible for the development of parenteral drug products Synthetic molecules from Phase 1 through Launch

Job Summary

  • The Pharmaceutical Development DP SM Parenterals group is responsible for the development of parenteral drug products Synthetic molecules from Phase 1 through Launch.
  • Develop the technical roadmap defining activities for industrialization readiness for the peptides portfolio through strategic collaboration with global stakeholders.
  • Advise and coach the CMC teams for the development of robust formulations and manufacturing processes managing risks and mitigations for parenteral DP synthetic molecules portfolio ensuring timely delivery of technical activities.

Matching Summary

The Pharmaceutical Development DP SM Parenterals group is responsible for the development of parenteral drug products Synthetic molecules from Phase 1 through Launch.

Skills & Requirements

Must-have

  • peptide parenteral formulations
  • synthetic molecule parenterals
  • formulation and manufacturing process development
  • industrialization readiness
  • regulatory and quality requirements
  • scientific strategies and decision-making

Nice-to-have

  • personal expression and open dialogue
  • genuine connections and respect
  • thrive personally and professionally
  • passion for innovation

Key Requirements

  • Ph.D. or master’s degree
  • minimum of 6 years of industry experience
  • authoring Drug Product (DP) sections of an NDA
  • developing and launching peptide combination products
  • Experience in peptide analytical techniques
  • aseptic manufacturing processes, scale-up, technology transfers
  • writing and reviewing regulatory CMC source and submission documents

Work Rights

Not specified

Tailored Resume

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