Lilly Advisor-Elanco Alterntive Innovation in Greenfield, Indiana
Main Purpose of Position:
The CMC leader will be responsible for CMC-related activities across the portfolio including process chemistry and route development, chemical manufacturing, pre-formulation, formulation and manufacture and supply of clinical trial materials. The ideal candidate will be a highly motivated individual with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.
Overall responsibility for all drug substance and drug product activities from preclinical development through clinical supplies for Phase 3 registration studies
Identification, selection and management of Contract Manufacturing Organizations (CMOs) for process optimization, cGMP manufacture and supply of Drug Substance (API) and Drug Product (DP) in support of ongoing clinical programs
Develop and implement strategy and DOE (design of experimentation) for optimizing and controlling quality of bulk API and DP using CROs and CMOs
Delivery of robust, scalable and cost-effective manufacturing routes and drug product formulations that meet or exceed the target clinical profile
Projection of API and DP needs for preclinical and clinical programs (with clinical team), and associated budgets
Formulation design/development for clinical programs
Management of supply chain and logistics in support of clinical studies
Writing and reviewing documents for INDs / regulatory section submissions; represent the company as the CMC expert before U.S. and European regulatory authorities
Prepare technical reports, publications and oral presentations
Key Leadership Responsibilities:
Work effectively with all Elanco colleagues and external collaborators to achieve overall Elanco R&D deliverables
Align perspectives from multiple functions and leaders into one cohesive strategy and action plan
Provide and accept challenge to deliver innovative solutions and create an innovative culture
Demonstrate energy, drive and intellectual curiosity needed to improve the overall performance of Elanco R&D
Create positive work environment that is aligned with company objectives
Create an engaging culture with “Play to Win” mentality
Identify and utilize methods to deliver individual objectives in a high quality, timely, cost-effective manner
Networking of funding sources and research partners
Quality mindset with flexibility to work in a innovative environment
Domestic and international travel required (20%)
Lilly 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.
Director- CMC Alternative Innovation
PhD or MS in chemistry or related scientific discipline with 10 years of product development experience.
Qualified candidates must be legally authorized to be employed in the United States. Eli Lilly and Company does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 7,000 employees worldwide. Founded in 1954, Elanco is a division of Lilly. Our worldwide headquarters and research facilities are in Greenfield, Indiana.
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