We have an exciting opportunity for a talented analytical development scientist to be a key contributor to our Analytical Sciences department. If you want to be part of a dynamic CMC drug development organization that is dedicated to boldly advancing transformative new medicines,
you are encouraged to apply.
About the Role:
- Take responsibility of all analytical activities and provide leadership for assigned drug development programs.
- Lead and manage analytical development activities at CMOs and CROs for clinical candidates in our pipeline.
- Solve technical challenges in developing and validating analytical methods (HPLC, GC, solid state characterization, dissolution and compendial) using sound scientific principles and prior experience to move project deliverables along.
- Serve as Analytical Sciences project representative on cross-functional drug development teams.
- Devise phase-appropriate quality control strategies, specifications and stability studies for drug substance and drug product.
- Author and review test methods, validation and stability protocols and technical reports.
- Lead investigations at external sites related to OOS, deviations, and unexpected analytical results.
- Author analytical sections of regulatory filings.
- Effectively communicate data and recommendations with project team members and senior
- Ph.D. in Analytical Chemistry or related discipline with 5+ years of pharmaceutical industry experience or M.S. with 8+ years of experience.
- Strong knowledge of pharmaceutical analytical development for drug substance and drug product.
- Strong understanding of GMP requirements and regulations for clinical and commercial CMC drug development.
- Proven track record in phase-appropriate analytical method development and validation for drug substance and drug product.
- Experience in setting GMP specifications, control strategies, and stability studies for drug substance and drug product.
- Experience in authoring M3 analytical sections of regulatory filings (IND/IMPD and NDA/CTA).
- Prior experience with leading analytical activities in cross-functional R&D project teams.
- Experience in managing analytical development activities at CROs and CMOs.
- Ability to manage multiple priorities in fast-paced drug development teams.
- Good written and verbal communication skills.