This role contributes to the preclinical development of novel food and companion animal health products by planning, coordinating, and implementation of pilot formulation studies in compliance with good research practices (GRP) and guidelines. This includes authoring of study protocols, designing and conducting drug physicochemical characterization studies (e.g., stability, particle size, solubility, excipient interaction, dissolution) in-house or via CROs, and providing technical oversight preclinical formulation development activities conducted by CROs/CMOs and internal. This position will be responsible for preclinical, enabling formulation development activities based on knowledge of molecular properties of the active pharmaceutical ingredient (API), preformulation experiments, and will include implementing innovative approaches to support the preclinical development of novel products used in studies via premixes, injectables, suspensions, spray-dried coatings, and formulated material in capsule
Functions, Duties, Tasks:
Proactively search for solutions, challenge current default practices, and present effective alternatives for product design and development
Work effectively and flexibly within and across all Elanco R&D teams and collaborate with key research partners in efficacy, pharmacology, ADME, and toxicology
Represents research on core teams focused on the discovery and selection of compounds for clinical and commercial development.
Create a positive work environment that is aligned with company objectives.
Providing technical advice and guidance to other teams and business areas.
Defines the initial product concept and works with development colleagues to estimate the cost of production
Manage project timeline and budget deliverables to facilitate delivery of the Elanco pipeline.
Possess a strong background in formulation development, oral drug delivery, biopharmaceutics and organic and physical chemistry.
Leads the physicochemical and biopharmaceutical profiling and risk assessment of compounds advancing through the discovery flow schemes.
Develop enabling formulations to facilitate preclinical pharmacokinetic, pharmacology and toxicology studies
Analytical method development to enable stability testing for API
Identify and select CROs, establish contract agreements, and maintain a positive business collaboration
Understands compound/scaffold properties as they impact developability and uses the understanding to facilitate discovery efforts.
Technical support for drug product delivery for early clinical assessment.
Assess projects for design and product risks and use resources to mitigate/discharge those risks before they impact the project delivery timeline
Internal Number: 51555
About Eli Lilly & Company
Company Overview At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees worldwide work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.