Formulation Project Manager

for our Site in Sisseln, Switzerland

The Aenova Group is one of the leading companies in the pharmaceutical and healthcare industry. With high quality standards, innovative technologies and a clear future orientation, Aenova has become Europe's market leader for the development and production of all common dosage forms and product groups in the business-to-business sector. The company which has its headquarters near Munich (Germany), operates 15 production sites and several sales offices in ten countries throughout the world. More than 4.300 employees contribute to the group’s success.
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.

Have we inspired your curiosity?

For any questions please contact the human resources department at +41 62 866 41 56.