Description
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 ( 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:
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