As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals’ lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco’s promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
Provide technical and scientific expertise for downstream process development for monoclonal antibodies and therapeutic proteins. Support the development, commercialization, and launch of new drug products for large molecules at both internal and external manufacturing sites. The role is focused on process development in lab and pilot scale, successful scale up and transfer to manufacturing, to ensure the supply meets market demand. Beyond the technical requirements, this position will require organizational management, collaboration, and excellent communication skills. It is expected that the person in this role will be an experienced scientist who has the potential to lead a group.
Functions, Duties, Tasks
- Provide technical leadership for downstream process development of early and late-stage large molecule (monoclonal antibodies, therapeutic proteins) R&D projects, ensuring phase- appropriate technical development, owning, and driving stage gate review processes.
- Ensure manufacturing concerns are addressed at phase-appropriate points of development; effectively apply principles of QbD with a thorough understanding of statistical approaches to experimental design. Mentor and train newer scientists on QbD and DOE design and analysis.
- Support the successful commercialization of new products, strategically and tactically, by partnering with R&D, TS/MS, supply chain, launch leaders, QA, and manufacturing sites throughout the development process with a focus on late-stage development.
- Lead and/or contribute to phase appropriate risk assessments for early and late-stage development.
- Author and review documents supporting regulatory submissions; respond to CMC questions from regulatory agencies.
- Support technical transfers, process implementation, and material delivery activities for pilot and pivotal Investigational Veterinary Product (IVP or CT) supply, registration, and validation batches.
- Apply technical expertise to scientific problems to support Biopharma Technical Development, TS/MS and manufacturing activities: understand the commercial scale operations to effectively develop scalable laboratory models, able to apply historical experience to current studies, and able to work in cross-functional atmosphere.
- Enable successful launch of R&D projects by ensuring robust control strategies are established.
- Participate in the evaluation of new business opportunities through due diligence, product reviews, and cost modeling.
- Support the identification, selection, and approval of contract manufacturers.
- Serve as a technical resource to Biopharma Technical Development, TS/MS, CMOs, and internal manufacturing sites.
- MS or PhD in chemistry, pharmaceutical sciences, biotechnology, or chemical engineering; relevant experience supporting manufacturing and commercialization activities, or equivalent experience in a science field additional to minimum experience listed below.
- 10 years (PhD) or 15 years (MS) of relevant experience in early-stage downstream purification process development (preferably for mammalian cell culture-based products) and late-stage commercialization activities for pharmaceutical and biological products, preferably in animal health.
- Demonstrated success in the development and commercialization of new pharmaceutical or vaccine technologies (e.g., API, drug product)
- Experience in regulated environments (e.g., FDA, EMA, EPA, USDA) and working under Good Manufacturing Practices.
- Strong interpersonal skills with proven ability to collaborate with and influence teams.
- Ability to manage multiple priorities and deal with ambiguity.
- Strong presentation skills and scientific/technical writing skills.
- Ability to work in interdisciplinary teams, influence diverse groups and effectively manage relationships.
- Demonstrated ability to work well independently, as well as in teams.
- Potential to lead a group of laboratory scientists.
- Fluent spoken and written English essential
- Design and execute research plan to develop a robust control strategy
- Up to 10-20% travel required
- Onsite in Greenfield, IN (New campus opening in Indianapolis, IN soon)
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 legally protected status