Senior Analytical Scientist, Drug Development & Regulatory

Elanco; Indianapolis (IN); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Multiple relocation packages

Two weeklong shutdowns (mid-summer and

8-week parental leave

9 Employee Resource Groups

Annual bonus offering

Flexible work arrangements

Up to 6% 401K matching

Job summary

Elanco Tiergesundheit AG in Indianapolis, IN, is seeking a Senior Research Scientist in Analytical Development to advance analytical and dissolution strategies for small molecule programs. You will support a diverse drug development pipeline and ensure global regulatory compliance.

Responsibilities include method development, data interpretation, technical leadership, and authoring regulatory submissions. The role requires strong leadership, collaboration across international teams, and

Qualifications

• PhD in Analytical Chemistry, Pharmacy, Pharmaceutical Sciences, or related field with minimum 5 years of pharma development experience.
• Experience with chromatographic (HPLC/UPLC), UV/VIS, and dissolution method development.
• Strong knowledge of quality and regulatory requirements for new drug products.
• Proven interactions with regulatory agencies (FDA/CVM, EMA) on analytical topics.

Responsibilities

• Develop, validate, and deliver robust analytical and dissolution methods and specifications.
• Interpret complex data, draw conclusions, and report results to internal teams and external conferences.
• Author and support international registration documents and submissions to global health authorities.
• Mentor and coach technical staff within analytical development.
• Ensure activities comply with GxP, SOPs, and HSE.

Skills

HPLC/UPLC

UV/VIS

Dissolution Methods

Regulatory Knowledge

FDA/EMA Interactions

Education

PhD in Analytical Chemistry

MS in related field

BS in related field

Tools

Mass Spectrometry (MS)

Job description

Elanco Tiergesundheit AG in Indianapolis, IN, is seeking a Senior Research Scientist in Analytical Development to advance analytical and dissolution strategies for small molecule programs. You will support a diverse drug development pipeline and ensure global regulatory compliance.

Responsibilities include method development, data interpretation, technical leadership, and authoring regulatory submissions. The role requires strong leadership, collaboration across international teams, and