Principal Research Scientist - Product development

Your Role

As a Technical Project Leader, you will play a central role in developing and advancing innovative small molecule/synthetic products for farm animals and pets. In this role, you will be responsible for guiding cross-functional technical teams, managing the CMC (Chemistry, Manufacturing, and Controls) strategy, and ensuring project milestones are achieved in partnership with Technical Development, Manufacturing, Quality, and Regulatory colleagues.

Responsibilities

• Guide the cross-functional CMC (Chemistry, Manufacturing, and Controls) team, aligning technical objectives with the overall project strategy to ensure the timely delivery of clinical materials and key milestones.
• Define and steer a scientifically sound technical development strategy, incorporating risk assessments and business objectives to guide the project from late research to development through submission.
• Serve as the primary CMC representative on the core project team, ensuring seamless communication, influence, and alignment between technical functions, project coordination, and external partners.
• Oversee the delivery of critical technical documentation, including Development History Reports, and support the preparation of regulatory CMC submissions in partnership with functional experts.
• Foster a culture of innovation and accountability, promoting collaboration and effective communication to stakeholders and between technical experts to solve complex challenges and to accelerate project timelines.

What You Need to Succeed (Minimum Qualifications)

• Education: Bachelor's Degree in a relevant scientific or engineering field (e.g., Pharmaceutical Sciences, Biology, Chemistry), or an equivalent level of experience.
• Experience: A minimum of 7 years of experience in synthetic/small molecule technical development, CMC, or manufacturing.

Top Skills

• Strong scientific background combined with demonstrated cross-functional guidance, effective communication and project management skills.

What Will Give You a Competitive Edge (Preferred Qualifications)

• Advanced degree (MS or PhD) in a related scientific field.
• Direct experience with CMC regulatory submissions, preferably for veterinary products.
• Demonstrated ability to think strategically and influence cross-functional teams and stakeholders.
• Experience with technical transfers to manufacturing sites.
• Some experience in biologics as well.
• Proficiency with project management software (e.g., MS Project).

Additional Information

• Travel: Approximately 10%
• Location: Global Elanco Headquarters - Indianapolis, IN - Hybrid Work Environment