Formulation Project Manager (m/f/d)

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 Tasks:

• 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

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