Project Manager External CMC Development

Description

• Scientific leadership and coordination for the development and optimization of production processes for new Active Pharmaceutical Ingredients (APIs).
• Perform assessment of chemical routes, CMC packages, COGS calculation and manufacturing & supply concepts.
• Ensure smooth implementation of processes in manufacturing plants ("scale up")
• Provide chemical expertise, consultancy, and propose quick solutions in troubleshooting within the internal and external manufacturing network
• Support development of concise control strategies for IND/IMPD filings
• Manage complex projects at suppliers with a high degree of independence
• Collaborate closely in and/or manage interdisciplinary project teams. Ensure appropriate alliance management in our network of external partners.
• Ensure compliance with external and internal rules and regulations for assigned supplier activities. Navigate within an interdisciplinary community of External CMC managers, project leads, the API network group as well as a network of project teams
• Support CMC assessment of in-licensing opportunities

Qualifications

• Ph.D. in Chemistry
• Strong background in synthetic chemistry and chemical process development
• Experiences with peptides would be an advantage
• Several years of experience in the pharmaceutical industry in Chemical Process Research & Development and optimization of API production processes, incl. understanding of regulatory requirements and quality standards
• Experience in managing external partners or working at a CDMOs
• Strong communication and project management skills
• High assertiveness, service orientation and enjoy working in a cross-functional team
• High ability to solve problems and to structure and simplify complex tasks
• Ability to effectively challenge the status quo and underlying assumptions to uncover fresh innovations and drive ideas into results
• Fluency in English, fluency in German would be an asset, willingness to learn German mandatory