The Senior/Principal Scientist will join the Analytical Development team to play a hands-on role in the development of analytical methods for drug product process development and manufacturing. This person will also aid in the validation of these processes and transfering to the QC teams.
- Take on leadership responsibility by mentoring junior staff members and acting as SME for the analytical team.
- Comply with GMP and FDA guidelines for drug product development and design.
- Manage projects and KPIs to ensure objectives meet timelines.
- Developing methods from scratch and product characterization
- Author and review technical reports, regulatory submissions, SOPs, validation protocols, and other cGMP documents.
Requirements & Skills:
- BS in Chemistry or Pharmaceuticals with 10+ years of experience, MS with 7+ years, OR PhD with 5+ years of industry experience in analytical method development
- 5+ years of experience of work under FDA/ICH compliance in a GMP environment
- Expert in small molecule chemistry
- Understanding of analytical instruments like HPLC
- Experience with nasal spray drug product development is a bonus
This is an on-site position.