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.)
