The Director, Analytical Technology, MSAT Onc/Neuro Products will lead a team of subject matter experts in analytical oversight of raw materials to APIs and OSD Oncology and Neurology drug products.
Requirements
- Ph.D. in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or a related field with a minimum of 7 years of experience in the pharmaceutical industry or M.S. in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences with a minimum of 10 years of experience in the pharmaceutical industry preferred.
- B.S. in Chemistry or a related field with a minimum of 12 years of experience in the pharmaceutical industry required.
- Demonstrated ability to coach and develop direct reports
- Consistently demonstrating growth mindset, adapting to and championing change, with a passion for building capabilities, to help shape the future of MSAT within a transforming organization.
- Experience in relationship management of Contract Research Organizations and contract laboratories.
- Extensive experience in the analysis of solid dosage forms, including HPLC, GC, KF, IC, LC-MS, UV-Vis, XRPD, DSC, FT-IR, SEM, optical microscopy, and microbial analysis.
- Proficient in solid-state analysis, physical characterization, and drug product dissolution.
- Experience in method development, validation, and routine analysis for Nitrosamine impurities in drug product test samples.
- Strong background in analytical control strategy development and execution.
- Previous experience in drafting and reviewing analytical sections of regulatory submissions, including new submissions (e.g., NDA/MAA) and post-approval Variations, as well as responding to health authority queries.
- Strong strategic thinking capabilities with a forward-looking perspective and demonstrated learning agility with a drive to solve problems.
- Excellent organizational, program management, and planning skills; adaptive learning, critical thinking, and the ability to work well in a team environment.
- Ability to work in a team-oriented environment that embraces change, risk, and flexibility.
- Excellent English communication skills – written and verbal, with strong presentation skills to create and deliver summaries and reports as needed.
- High proficiency in Word, Excel, PowerPoint, SmartSheet and statistical software (JMP, Prism).
Benefits
- Medical
- Dental
- Vision
- Flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off)
- 401(k)
- Life and disability insurance
- Recognition programs
