Your Role:
As a Senior Research Scientist in Analytical Development, you will lead analytical and dissolution control strategies for a small-molecule portfolio, supporting the drug development pipeline with analytical activities to meet global quality and regulatory standards.
Responsibilities:
- Develop, validate, and deliver analytical and dissolution methods and specifications; evaluate and implement new technologies to advance drug development.
- Interpret complex scientific data; report and present technical results to internal teams and external scientific conferences.
- Author/support international registration documents with manufacturing and regulatory colleagues for commercialization and global health authority technical submissions.
- Mentor and coach emerging technical talent; foster scientific excellence.
- Ensure compliance with internal/external quality standards and guidelines, including GxP, SOPs, and HSE.
Minimum Qualifications:
- PhD (Analytical Chemistry/Pharmacy/Pharmaceutical Sciences or related) + 5 years pharmaceutical development; or MS + 10 years; or BS + 15 years.
- Expertise in chromatographic (HPLC/UPLC), spectroscopic (UV/VIS), and dissolution method development (USP Apparatus II and IV).
- Strong knowledge of quality/regulatory requirements and a track record of successful regulatory interactions (e.g., FDA/CVM, EMA) on analytical topics.
Preferred Qualifications:
- Significant dissolution development and regulatory submission experience.
- Mass spectrometry (MS) and other analytical method development experience.
- Scientific leadership; strong problem-solving and creative thinking.
- Collaboration across interdisciplinary and international teams.
- Regulated environment experience (e.g., GMP).
Additional Information:
- Travel: 10%
- Location: Indianapolis, IN (Hybrid)
Benefits and Perks:
- Multiple relocation packages; two weeklong shutdowns; 8-week parental leave; annual bonus offering; flexible work arrangements; up to 6% 401K matching.