Freelance Consultant CMC Lead (m/w/d)

Key Responsibilities

• Responsible for drug substance, CMC development activities from late stage to product licensure
• Resource planning, project timelines and budget.
• Provide input to project feasibility and suggest changes to ensure successful completion of assigned projects.
• Interface with project governance committees (internal and external) as required

Qualifications

• 8 years plus experience in late stage development and GMP manufacturing of pharmaceutical products.
• Familiarity with regulatory guidance’s pertaining to the Chemistry, Manufacturing and Control of manufacture pharmaceutical products.
• Experience in project management of complex technical projects involving several internal and external stakeholders.
• Ability to think strategically, create innovative strategies, drive changes, manage ambiguity and able to anticipate future trends and consequences.
• Excellent verbal and written communication skills in English and German.