The Role

Reporting to the Director, Drug Product Formulation & Development, the Senior Scientist, Formulation & Drug Product will play a vital role in planning, coordinating, and overseeing the execution of drug product development and manufacturing at CDMOs. This role requires an understanding and hands-on experience with equipment and processes commonly used for developing solid oral formulations. This is an opportunity to develop novel formulations and drug products to advance our pipeline of therapeutics and be part of a growing biotech.

Responsibilities

• Responsible for supporting Formulation development and Drug Product manufacturing activities at CDMOs
• Manage relationships with CDMOs, including coordination and technical oversight, to ensure timely delivery of cGMP products to support clinical trials.
• Review and provide oversight of all documentation related to the production of the drug products, including development, scale-up, validation protocols/reports, batch records, deviations, process excursions, SOPs, etc.
• Support future DP Manufacturing Optimization, Quality by Design (QbD), and Product Performance Qualification (PPQ) activities.
• Build strong cross-functional relationships and work collaboratively with CMC Drug Substance, Clinical Operations, and Regulatory Affairs.
• Contribute to technical reports, regulatory filings, and presentations to internal and external stakeholders.

Minimum Qualifications

• Masters, or PhD in Pharmaceutical Sciences, Chemical Engineering, or related fields with pharmaceutical industry experience (5-7 years for MS, 3-5 years for PhD)
• Working knowledge and know-how to support preclinical studies with various formulation approaches and delivery routes.
• Experience in oral solid formulation development of poorly soluble (BCS Class II/IV) compounds (small molecules).
• Experience in managing projects with external CDMOs.
• Excellent interpersonal and communication skills
• Proficient with Microsoft Excel, PowerPoint, and Project

The salary range for this role is: $155,000 - $176,000.