Elanco is a global animal health company that develops products and knowledge services to prevent and treat disease in food animals and pets in more than 90 countries. With a 64-year heritage, we rigorously innovate to improve the health of animals and benefit our customers, while fostering an inclusive, cause-driven culture for more than 5,800 employees. At Elanco, we’re driven by our vision of food and companionship enriching life – all to advance the health of animals, people and the planet. Learn more at www.elanco.com
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
advanced degree in organic or physical chemistry, pharmaceutical sciences or other related disciplines with knowledge of preformulation/developability. Experience: A minimum of 5 – 10 years relevant industry with M.S. or or academic experience with a Ph.D or BS degree in biology with 10-15 years of formulation experience.
Expertise in profiling and interpretation of physicochemical properties of pharmaceutical compounds.
Design and development of preclinical enabling formulations.
Basic understanding of pharmacokinetic principles and drug product/process design factors impacting in vivo performance of drug products.
Basic understanding of drug delivery systems that are required to tailor the in vivo PK profiles for some drugs.
Experience identifying the solid form and physicochemical properties of the drug substance necessary to provide acceptable drug product performance.
Domestic travel required (10-25%), and some international travel required (<10%).
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