CMC Expert Analytical Development – Parenterals & Devices

You will take on a leading scientific role in the analytical development of parenteral dosage forms and combination products with devices and advise project teams on CMC issues.

Tasks

• Provide scientific advice and strategic input for project teams and executives
• Participate as an experienced mentor in the creation of regulatory documents
• Solve complex CMC problems and lead root cause analyses
• Act as an interface between different teams and address scientific challenges
• Analyze risks across the portfolio and develop portfolio-wide solutions
• Drive strategic cross-functional projects to improve operational effectiveness
• Train, mentor, and guide scientific personnel

Profile

• Advanced academic degree, preferably a doctorate, in Pharmaceutical Sciences, Chemistry or a related field
• Extensive experience in pharmaceutical research and development
• In-depth knowledge in the analytical development of parenterals and combination products with devices
• Experience with synthetic molecule modalities such as oligonucleotides, peptides or classical small molecules is an advantage
• Proven success in the preparation of regulatory dossiers (NDA) and the transfer to commercial manufacturing
• Strong analytical skills and pronounced communication skills

Company

Pharma- und Biotechentwicklung

Application: online via Try&Hire, with your profile — https://tryandhire.io/ch-de/einsaetze/e/cmc-expertin-experte-analytische-entwicklung-parenteralia-devices-tah-fbhyg/