Responsibilities:
Develop, validate, and deliver robust analytical and dissolution methods and specifications, while driving the evaluation and implementation of new technologies to advance our drug development process.
Interpret complex scientific data, draw relevant conclusions, and effectively report and present technical results to internal teams and at external scientific conferences.
Author and support the generation of international registration documents, partnering with manufacturing and regulatory colleagues to drive drug product commercialization and technical submissions to global health authorities.
Mentor and coach emerging technical talent within the analytical development function, fostering a culture of scientific excellence.
Ensure all activities are compliant with internal and external quality standards and guidelines, including GxP, SOPs, and HSE.
What You Need to Succeed (minimum qualifications):
Education: PhD in Analytical Chemistry, Pharmacy, Pharmaceutical Sciences, or a related field with a minimum of 5 years of experience in pharmaceutical development; in a related field with a minimum of 10 years of experience; or in a related field with a minimum of 15 years of experience.
Experience: Strong expertise in chromatographic (HPLC/UPLC), spectroscopic (UV/VIS), and dissolution method development (specifically with USP Apparatus II and IV).
Top 2 skills: Extensive knowledge of current quality and regulatory requirements for new drug products and a demonstrated track record of successful interactions with regulatory agencies (, FDA/CVM, EMA) on analytical topics.
What will give you a competitive edge (preferred qualifications):
Significant experience in dissolution development and regulatory submissions.
Experience with mass spectrometry (MS) and other areas of analytical method development.
Proven scientific leadership skills combined with strong problem-solving and creative thinking abilities.
Demonstrated ability to collaborate and positively impact interdisciplinary and international teams.
Experience working in regulated environments (, GMP).
Additional Information:
Travel: 10%
Location: Global Elanco Headquarters - 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
Sr Research Scientist • Indianapolis, IN
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