New Manager, Drug substance, Commercial Manufacturing Operations

Responsibilities:

• Management of commercial API CMOs and RSM suppliers from raw material ordering oversight to manufacturing and release of API
• Oversees investigations related to deviations and complaints, with proper evaluation of impact to product and processes
• Identifies and leads key process problem resolution activities and process improvement initiatives, resolves issues

Who You Are:

• Ph.D. (ideally organic chemistry) with 2+ years relevant experience, or BS/MS with 5+ years relevant experience or process chemistry experience
• Familiarity with FDA and ICH guidelines, with focus in ICH Q7 and thorough understanding of cGMP, quality and regulatory requirements
• Self-motivated individual with strong attention to detail and time management skills with excellent oral and written communication skills

Rewarding Those Who Make the Mission Possible:

• Market leading compensation
• Hybrid work model - we value your flexibility in how you work, but encourage time in the office to strengthen our culture, collaboration, and sense of community
• We provide career development through regular feedback, continuous education and professional development programs