Position Objectives:
Lead formulation development work at Spiral to support new products, including pre-formulation activities, formulation development and analytical testing. Design and evaluate new delivery platforms for local delivery in the ear, with the focus on long-lasting gel formulations. Develop drug product manufacturing processes, support CMOs in manufacturing and testing of drug products for clinical development programs. As a key member of a small and growing team, this individual will directly impact a wide range of activities along the product development pathway and will collaborate directly with colleagues across multiple functions.
Essential Functions:
Lead pre-formulation, formulation development for new drug candidates (small molecules, peptides and proteins)
Design, evaluate and characterize new delivery platforms for local delivery in the ear
Lead analytical testing of new formulation including selection of appropriate testing strategy, method development and development of product specifications as needed.
Develop preclinical formulations and manufacturing processes for new drug products
Support CMOs in manufacturing and testing of new products for clinical programs.
Oversee detailed technical requirements, resource requirements, timelines and decision points of CMC activities for the new programs
Prepare and/or oversee the preparation of the CMC section(s) of regulatory submissions
Education:
Ph.D. in Analytical Chemistry, Chemical Engineering, Materials Science, Pharmaceutical Sciences or a related discipline, or an equivalent level of knowledge and experience.
Experience:
3-8 years of experience in formulation development and drug product manufacturing
In-depth scientific knowledge and hands-on experience in formulation development is required. Experience in extended-release local delivery systems is highly desirable
Knowledge of analytical testing requirements for specific types of products is a must. Experience in analytical method development is desired
Knowledge of GMPs and regulatory requirements as related to formulation development and drug product manufacturing is preferred.
Experience with protein formulation and/or controlled delivery/ sustained release systems is preferred.
Previous supervisory experience is a plus.
