01Responsibilities
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
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 setting. 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 perks 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
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other .
