Beschreibung

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 - that's what we stand for as Aenova, one of the world's leading contract manufacturers and developers for the pharmaceutical industry with 4,000 employees at 15 sites. Our site in Sisseln is a competence center for complex and innovative solids.

What can you expect?

• 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

What should you bring?

• 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
• Knowledge of 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
• Open to new ideas
• Excellent communication skills
• Strong ability to work in a team
• High customer centricity

What we offer:

• A growth-oriented, dynamic and international environment
• Challenging tasks across the sites but also corperate wide
• Further training and education opportunities
• The site Sisseln is characterized by the very familiar, supportive, friendly and respectful environment with its approximately 160 employees

If these tasks in a future-proof corporate group attract you, then we would like to get in touch with you.

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