Peter Luetolf

Experience

• 

  Mepha

  Sept 1997 - Dec 2000

  Head Pharmaceutical Development

  Formulation and process development; support of market products; author of registration documents.

• 

  Roche Pharmaceuticals

  Jan 2001 - now

  Generate and drive the technical development strategy and technical plan for assigned early and late stage development projects. Full leadership responsibility to drive all related technical development activities towards successful filing and launch in key countries. Represent technical /CMC in core teams and create transparency and understanding of technical needs.Build and lead the technical development team.NDA/MAA filing of Cotellic.Member of the QbD Expert Team. Development of robust manufacturing processes for new drug products; Quality by Design; Filing and launch of ZELBORAF and TARCEVA; Transfer to commercial production and Validation; Clinical supply; Member of global technical project teams; part time Technical Development Leader for one project. Coordination of complaints; issue management; initiation of quality improvements.

  • Technical Development Leader

    Jan 2014 - now

  • Group Head Process Development Solid Dosage Forms

    Jul 2003 - Dec 2013

  • Quality Manager

    Jan 2001 - Jun 2003