Formulation Project Manager 100%

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.
Formulation Project Manager 100% (f/m/d)
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 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
Your motivation
Are you looking for new challenges in a highly competitive environment? And you want to tackle them creatively and on your own responsibility? Do you prefer a "get-it-done" culture and think in terms of solutions rather than problems? What are you waiting for? We would be happy to explain our corporate benefits in a personal conversation!
If you have any questions, please contact the local HR Departement: jidb42523fa jit0416a jiy26a