Biologics Formulation Development Director

Job Summary

Seeking a strategic leader, the remote Associate Director of Biologics Formulation Development will manage formulation strategies for a new bispecific fusion protein program, focusing on protein stability, manufacturability, and product presentation for intravenous and subcutaneous administration.

Key Responsibilities

• Lead formulation development strategy for a new bispecific fusion protein from preclinical stage through clinical development
• Design and execute studies to assess protein stability, aggregation, degradation pathways, and developability under relevant formulation conditions
• Collaborate with cross-functional teams and external partners to ensure alignment between formulation strategy and clinical needs

Required Qualifications

• Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, or a related field with 8+ years of relevant industry experience; or M.S. with 10+ years of relevant experience
• Deep expertise in formulation development for biologics, including monoclonal antibodies and bispecific antibodies
• Strong hands-on experience with protein stability assessment and formulation screening for early- and late-stage development
• Familiarity with regulatory expectations for formulation and drug product development in biologics programs
• Experience working with external CDMOs and managing outsourced formulation and drug product development activities