Your Role: Principal Research Scientist, Analytical Development (SynTD)As the Principal Research Scientist, Analytical Development, you will support Elanco's Technical Development (TD) organization. This position is broadly responsible for analytical development activities of animal health products with a concentrated expertise in dissolution control strategy and synthetic molecule analytical development. As part of technical development teams, the role is expected to support drug development with a diverse range of responsibilities.
Your Responsibilities:- Develop and deliver relevant 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 the generation of international registration documents and interact with global health authorities.
- Partner with manufacturing and regulatory representatives to drive drug product commercialization activities and technical submissions to global health authorities.
- Drive the evaluation and implementation of new technologies in dissolution and analytical development, applying the latest scientific thinking to help bring new drug products to market.
- Mentor and coach emerging technical talent within the function.
- Ensure compliance with external and internal guidelines/quality standards (e.g., SOPs, GxP, HSE, and Animal Welfare).
What You Need to Succeed (minimum qualifications):- Education: PhD in Analytical Chemistry, Pharmacy, Pharmaceutical Sciences, or a related field, with a minimum of 7 years of experience in pharmaceutical development; experience specifically in analytical development is highly preferred, ideally with experience in various dosage forms. M.S. in a related field with a minimum of 12 years of experience in the pharmaceutical industry, or B.S. in a related field with a minimum of 16 years of experience in the pharmaceutical industry.
- Experience: Strong expertise in chromatographic (HPLC/UPLC) and spectroscopic (UV/VIS) method development, and recognized expertise in dissolution, particularly with USP Apparatus II (Paddles) and IV (Flow Cell).
- Top 2 skills:
- Extensive knowledge of current quality and regulatory requirements for new drug products.
- Demonstrated track record of interacting with regulatory agencies (e.g., FDA/CVM, EMA) on analytical topics.
What will give you a competitive edge (preferred qualifications):- Significant experience with dissolution development and preparing regulatory submissions.
- Experience working in regulated environments (e.g., GMP).
- Proven scientific leadership skills.
- Strong collaborator with the ability to positively impact interdisciplinary and international teams.
- Strong problem-solving skills, including strategic and creative thinking.
- Experience in analytical method development in areas outside of dissolution.
Additional Information:- Travel: Approximately 10% travel required.
- Location: Indianapolis, IN - Hybrid Work Environment
Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
- Multiple relocation packages
- Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
- 8-week parental leave
- 9 Employee Resource Groups
- Annual bonus offering
- Flexible work arrangements
- Up to 6% 401K matching
