Formulation Project Manager 100% (f/m/d)
📋 Détails de l'offre
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.
Your key responsibilities
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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
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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
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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
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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
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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
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Monitoring experiments (e.g. process development, implementation of new formulation techniques) and ensuring complex data are interpreted in a scientifically correct way
Your profile
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Degree in pharmacy and/or technology
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In-depth knowledge of pharmaceutical technology, pharmaceutical process requirements and product development, Tech Transfers / MS&T
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Experience with solid dosage forms in a GMP regulated environment is an advantage
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Knowledge of pharmaceutical excipients and regulations and monographs of the European/United States and Japanese Pharmacopoeia and other relevant pharmaceutical regulation
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Deep understanding of relevant regulations such as ICH guidelines, AMWHV, EU-GMP guidelines and other official guidelines of the EMA and FDA
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Solution-oriented, analytical way of thinking
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Good coordination and organizational skills
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Entrepreneurial thinking, flexibility, innovative spirit
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Systematic, structured and conscientious way of working as well as open to new ideas
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Excellent communication skills in German (mother tongue) and English
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Strong ability to work in a team
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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: +41 62 866 42 42
Saisissez cette opportunite et postulez des aujourd'hui.
🏢 À propos de l'entreprise
Entreprise dans le secteur Services en général