Formulation Project Manager 100% (f/m/d)

for our Site in Sisseln Switzerland

Would you like to make a valuable contribution to the health of patients And do something really meaningful on your own responsibility Then we look forward to hearing from you! Excellence beyond manufacturing - thats what we stand for as Aenova one of the worlds leading contract manufacturers and developers for the pharmaceutical industry with 4000 employees at 15 sites. Our site in Sisseln is a competence center for complex and innovative solids.

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 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 andregulations 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

Your motivation

If you have any questions please contact the local HR Departement: