Principal Research Scientist - Analytical Development Synthetic Technical Development
Elanco
August 17, 2026
Remote friendly (Indianapolis, IN)
United States
Clinical Research and Development
Principal Research Scientist, Analytical Development (SynTD)
Your Responsibilities:
- Develop and deliver analytical and dissolution methods and specifications, ensuring compliance with industrial (GxP) and regulatory requirements (VICH/ICH).
- Interpret results, evaluate data, and draw relevant conclusions.
- Report and present scientific/technical results internally, create external publications, and present at scientific conferences.
- Write or support international registration documents and interact with global health authorities.
- Partner with manufacturing and regulatory representatives to support commercialization activities and technical submissions.
- Evaluate and implement new technologies in dissolution and analytical development.
- Mentor and coach emerging technical talent.
- Ensure compliance with external and internal quality standards (e.g., SOPs, GxP, HSE, Animal Welfare).
What You Need to Succeed (Minimum Qualifications):
- PhD in Analytical Chemistry/Pharmacy/Pharmaceutical Sciences (7+ years pharmaceutical development) OR MS (12+ years) OR BS (16+ years).
- Strong expertise in HPLC/UPLC and UV/VIS method development; recognized dissolution expertise (USP Apparatus II and IV).
- Extensive knowledge of quality and regulatory requirements for new drug products.
- Demonstrated experience interacting with regulatory agencies (e.g., FDA/CVM, EMA) on analytical topics.
Preferred Qualifications:
- Dissolution development and regulatory submission experience.
- Regulated environment experience (e.g., GMP).
- Scientific leadership; strong collaborator; strong problem-solving.
- Analytical method development experience outside dissolution.
Additional Information:
- Travel: ~10%
- Location: Indianapolis, IN (Hybrid)
Benefits (highlights):
- Multiple relocation packages; two weeklong shutdowns (mid-summer/year-end) + PTO; 8-week parental leave; 9 Employee Resource Groups; annual bonus; flexible work arrangements; up to 6% 401K matching.
Your Responsibilities:
- Develop and deliver analytical and dissolution methods and specifications, ensuring compliance with industrial (GxP) and regulatory requirements (VICH/ICH).
- Interpret results, evaluate data, and draw relevant conclusions.
- Report and present scientific/technical results internally, create external publications, and present at scientific conferences.
- Write or support international registration documents and interact with global health authorities.
- Partner with manufacturing and regulatory representatives to support commercialization activities and technical submissions.
- Evaluate and implement new technologies in dissolution and analytical development.
- Mentor and coach emerging technical talent.
- Ensure compliance with external and internal quality standards (e.g., SOPs, GxP, HSE, Animal Welfare).
What You Need to Succeed (Minimum Qualifications):
- PhD in Analytical Chemistry/Pharmacy/Pharmaceutical Sciences (7+ years pharmaceutical development) OR MS (12+ years) OR BS (16+ years).
- Strong expertise in HPLC/UPLC and UV/VIS method development; recognized dissolution expertise (USP Apparatus II and IV).
- Extensive knowledge of quality and regulatory requirements for new drug products.
- Demonstrated experience interacting with regulatory agencies (e.g., FDA/CVM, EMA) on analytical topics.
Preferred Qualifications:
- Dissolution development and regulatory submission experience.
- Regulated environment experience (e.g., GMP).
- Scientific leadership; strong collaborator; strong problem-solving.
- Analytical method development experience outside dissolution.
Additional Information:
- Travel: ~10%
- Location: Indianapolis, IN (Hybrid)
Benefits (highlights):
- Multiple relocation packages; two weeklong shutdowns (mid-summer/year-end) + PTO; 8-week parental leave; 9 Employee Resource Groups; annual bonus; flexible work arrangements; up to 6% 401K matching.