We are supporting a search for a Principal Analytical Scientist to support CMC efforts at a mid-sized pharmaceutical company in the RTP area.

Responsibilities

• Serve as the Analytical CMC lead for the development of new drugs, guiding projects from Phase I to commercialization.
• Develop and provide phase-appropriate analytical strategies to ensure seamless drug development, meeting milestones and deliverables in a timely manner.
• Manage analytical support for drug substance development, product formulation/process development, and process validation.
• Direct a small team of scientists (BS and Master levels), providing leadership, coaching, and professional development to direct reports.
• Review and author regulatory documents such as IMPD, IND, NDA, etc.
• Prepare responses to questions from health authorities regarding analytical aspects of drug development.
• Contribute as an analytical subject matter expert (SME) in due diligence activities.
• Prepare and review quality documents, SOPs, guidelines, protocols, reports, etc.

Qualifications

• PhD in Analytical Chemistry or a related field with 5 years of industry experience
• Experience independently developing analytical methods using HPLC, GC, and MS
• Excellent communication and interpersonal skills
• Experience collaborating with cross-functional teams (QC, Regulatory, Clinical, etc.)