We are recruiting for a Formulation Scientist who will oversee formulation development projects and the related manufacturing duties. Experience in Solid Oral Dosage is a must. You will be responsible for 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.
* Accountable for all formulation and manufacturing process deliverables including scientific documentation and excipient qualification.
* Create, own and update formulation project plans aligned with the control strategy.
* Drive Drug Product development and supply activities with scientific and technological excellence.
* Closely collaborate with your Drug Product subteam team members understand, identify and manage with them together critical aspects around Drug Substance, Drug Product, packaging and analytics.
* Drive regular exchange with Biopharmaceutics Experts to understand critical factors for absorption and Drug Product 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 Drug Product related questions in inspections and support Health Authority requests.
* 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.
* Preferably educated to a PhD level in Scientific or relevant discipline.
* 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 scientific knowledge and skills
* 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.
* Good project management skills.
Kontakt: Luchele Mendes: +41 (0) 44 215 2051
Michael Bailey International is acting as an Employment Business in relation to this vacancy.