Scientist/ Senior Scientist, Product Development

About the Role

Lead formulation development work 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 a focus on long-lasting gel formulations. Develop drug product manufacturing processes and 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 collaborate directly with colleagues across multiple functions.

Responsibilities

• Lead pre-formulation and 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 formulations, 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 new programs.
• Prepare and/or oversee the preparation of the CMC section(s) of regulatory submissions.

Requirements

• 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.
• Experience in extended-release local delivery systems is highly desirable.
• Knowledge of analytical testing requirements for specific types of products is required.
• Experience in analytical method development is desired.
• Knowledge of GMPs and regulatory requirements 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.