Scientist​/Senior Scientist, Product Development

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.

• 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

Ph.D. in Analytical Chemistry, Chemical Engineering, Materials Science, Pharmaceutical Sciences or a related discipline, or an equivalent level of knowledge and 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.