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

SwissCo Services AG / Aenova Group

SwissCo Services AG / Aenova Group

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Key information

Would you like to make a valuable contribution to the health of patients? And do something really meaningful on your own responsibility?

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: +41 62 866 41 56

SwissCo Services AG • Member of the Aenova Group • Bahnhofstrasse • 4334 Sisseln, Switzerland

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