Formulation Project Leader

Reference Number: 896196-W
Type of placement: Contract, 24 Months
Location: CH, NW

Introduction:

As a Scientific Technical Leader II / Formulation Project Leader , you will be responsible for creating and driving scientific & technological excellence for the formulation development and manufacturing work in your assigned project (such as formulation- and process-design, control strategy, quality risk management, authoring of development documents and manufacturing instructions for technical and GMP manufacture incl. handling of deviation) in close collaboration with operations, analytics, particle engeeniring and biopharmaceutical experts among other stakeholders .

Main Responsibilities:

  • Accountable for all formulation and manufacturing process deliverables incl. scientific documentation;
  • Create, own and update formulation project plans aligned with the control strategy being in line with the overall DP and TRD project plan, Development Manuals, SOPs and PHAD strategy;
  • Drive DP development and supply activities with scientific and technological excellence;
  • Represent formulation development in the Drug Product subteam;
  • Closely collaborate with your Drug Product subteam team members understand, identify and manage with them together critical aspects around DS, DP, packaging and analytics;
  • Drive regular exchange with Biopharmaceutics Experts to understand critical factors for absorption and DP-performance and build this understanding into your development strategy;
  • Drive regular exchange with internal SMEs such as the Technology Focus Groups covering pharmaceutical unit operations of your Drug Product and build their guidance into your development strategy;
  • Author Create documents (such as CSF, FMI development reports) and Supply documents (MIs, PHAD application sheets) to allow timely start of development trials, process transfers and supply activities;
  • Contribute to the generation of filing dossiers, answer DP related questions in inspections and support Health Authority requests;
  • Support the DPPL during the EP/LP project review process (CheckPoints) and at relevant governance boards;
  • Take diligently accountability for handling timely Change Requests and for deviation handling via AQWA & TQW, and support the creation of SAP-information systems;
  • Take accountability for the preparation and representation of project/product-related aspects during internal and health authority inspections (e.g. batch production records, project/product-related change requests and deviations, etc.

Qualifications and Experience:

  • Education minimum: Advanced degree in scientific or relevant discipline Ph.D. in scientific or relevant discipline or equivalent;
  • 5 - 10 years of successful industry experience in the development of pharmaceutical formulations. (ideally oral solid dosage forms), solid understanding of QbD and biopharmaceutics);
  • Interdisciplinary thinking and interest in collaboration with other functions;
  • Excellent knowledge of laboratory and/or technical tools (e.g. QbD, statistical software, PAT);
  • Broad and profound understanding of formulation development activities;
  • Strong knowledge of relevant GLP, GMP regulations and policies;
  • Strong presentation skills and scientific/technical writing skills;
  • Good communication skills, organizational, planning and negotiation skills
  • Fluency in English; German and/or French desired;
  • Relevant working/residency permit or Swiss/EU-Citizenship required.

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