Senior Scientist, Drug Product

Job Title: Senior Scientist, Drug Product

Skills: NDA, Drug Product, Analytical Chemistry

Join a forward-thinking leader in the pharmaceutical manufacturing sector dedicated to delivering innovative drug products that improve patients’ lives. This role offers the chance to lead analytical development and product characterization efforts across the drug development pipeline, collaborating with cross-functional teams and external partners to bring new therapeutics to market.

• Lead analytical method development, transfer, validation, release, and stability testing for drug product portfolios, including oversight at CDMOs and CROs.
• Design and conduct experiments, interpret data, and present findings to senior leadership and project stakeholders.
• Develop and execute strategic project plans from discovery through clinical and commercial stages, ensuring timely delivery of product requirements.
• Author and review technical reports, data packages, and regulatory filings such as INDs, NDAs, and annual reports.
• Manage project budgets, coordinate contracts and invoices, and maintain high-quality deliverables on schedule.

• Ph.D. or equivalent in analytical chemistry with 3+ years of relevant experience.
• Extensive hands‑on experience with UHPLC, GC, LC‑MS, GC‑MS, SFC, dissolution, DSC, TGA, XRPD, and related analytical techniques.
• Proficiency in method validation, product specifications, and analytical reporting.
• Strong understanding of ICH guidelines, GLP, and cGMP laboratory practices.
• Ability to work independently and collaboratively with CROs, CDMOs, and cross-functional teams.

• Knowledge of DMPK, toxicology, and clinical development processes.
• Experience with regulatory interactions and health authority submissions.
• Demonstrated scientific leadership through publications and conference presentations.
• Familiarity with budget planning and contract management.
• Experience in innovative analytical technologies such as SFC or advanced spectroscopic methods.