Location: Sisseln, Switzerland
Formulation Project Manager (f/m/d) – 100%
Your key responsibilities
* Supervision, organization, and coordination of the manufacture of preclinical trials as well as clinical investigational medicinal products (IMPs) in development projects in accordance with the applicable GMP guidelines
* Supervision, organization and coordination of pharmaceutical transfer projects with a focus on oral solids (such as tablets, film‑coated tablets, ODTs, capsules, pellets etc.) in accordance with applicable guidelines
* Development of suitable formulations and/or manufacturing processes for novel and new generic drugs, taking into account pharmaceutical‑technological knowledge and the specific properties of active ingredients and excipients
* Organization of development activities in cooperation with other departments; work closely together with the Lab Operators to guide them and in alignment with Local Project Management as well as QA/QC, Production and MS&T
* Creation of manufacturing documents including instructions for sampling and implementation of in‑process controls according to valid SOPs and in accordance with applicable guidelines to ensure the proper manufacture of medicinal products under development and clinical investigational medicinal products
* Monitoring experiments (e.g. process development, implementation of new formulation techniques) and ensuring complex data are interpreted in a scientifically correct way
Your profile
* Degree in pharmacy and/or technology
* In‑depth knowledge of pharmaceutical technology, pharmaceutical process requirements and product development, Tech Transfers / MS&T
* Experience with solid dosage forms in a GMP regulated environment is an advantage
* Knowledge of pharmaceutical excipients and regulations and monographs of the European/United States and Japanese Pharmacopoeia and other relevant pharmaceutical regulation
* Deep understanding of relevant regulations such as ICH guidelines, AMWHV, EU‑GMP guidelines and other official guidelines of the EMA and FDA
* Solution‑oriented, analytical way of thinking
* Good coordination and organizational skills
* Entrepreneurial thinking, flexibility, innovative spirit
* Systematic, structured and conscientious way of working as well as open to new ideas
* Excellent communication skills in German (mother tongue) and English
* Strong ability to work in a team
* High customer centricity
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