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Head of GMP Manufacturing

Sanofi-Aventis

Frankfurt, Germany

Your responsibilities

  • Ensure GMP manufacturing of bulk products for clinical use for PDP, BDP and potential external cooperation and provide those in time to the SCP Clinical supplies for packaging. The internal as well as external manufacturing via outsourcing of all pharmaceutical dosage forms and modified comparators are in the scope of this task;
  • Support the global “parenteral platform” which coordinates the exchange on GMP Operations business of the Parenteral Pilot plants;
  • Facilitate smooth transfer of formulations and processes from local Product and Process Development or from R&D/GMP Manufacturing of a different site to GMP Manufacturing FF;
  • Ensure smooth scale-up and transfer of formulations and processes to Industrial Affairs in collaboration with Product and Process Development;
  • Ensure adequate GMP Manufacturing's contribution to regulatory dossiers;
  • Contribute to decisions on development strategies (NCEs and LCM), research programs and elaboration of scientific strategies by active participation in review meetings;
  • Serve as internal interface for collaborations involving multiple labs;
  • Participate and contribute to the CR Coordination Teams and Technology Transfer Teams (transfer to Industrial Affairs) representing GMP Manufacturing;
  • Define best ways of working practices and assure implementation in GMP manufacturing parenterals.

Your qualifications

  • Pharmacist, PhD in Pharmaceutical Technology or specialized in Pharmaceutical Engineering;
  • Minimum 5 years of expertise in pharmaceutical industry;
  • Broad knowledge and expertise in GMP compliance according to EU-GMP guidelines and CFR including calibration/qualification of premises and equipment, cleaning qualification, etc.);
  • Background in formulation development as well as process development/optimization and manufacture, regulatory requirements, material characteristics and industrialization;
  • Basic analytical skills (testing of dosage forms, intermediates and in-process controls);
  • Sense for strategy, flexibility, communication skills, teamwork, networking and customer orientation;
  • Fluent in English;
  • Basic knowledge of French.

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