Director, Biologics Formulation Development

About the role

We are seeking an experienced and strategic leader in formulation development to lead development activities for a new bispecific fusion protein program. This individual will be responsible for designing and advancing formulation strategies from early-stage candidate assessment through clinical development, with a strong focus on protein stability, manufacturability, and product presentation for both 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, viscosity, and developability under relevant formulation conditions.
• Develop liquid and, where appropriate, lyophilized formulations to support both IV and SC presentations.
• Lead excipient screening, buffer optimization, pH optimization, surfactant selection, and stress stability studies to identify robust drug product formulations.
• Drive high-concentration formulation development for subcutaneous delivery, including syringeability, injectability, and device compatibility assessments.
• Partner closely with Analytical Development to establish appropriate characterization methods for formulation screening, stability assessment, and comparability studies.
• Collaborate with Drug Substance, Process Development, Quality, Regulatory, Clinical Supply, and external CDMOs to ensure alignment between formulation strategy, manufacturability, and clinical needs.
• Provide technical leadership for drug product process development, fill-finish considerations, container closure selection, and tech transfer activities.
• Serve as the formulation subject matter expert during regulatory interactions and contribute to CMC sections of regulatory filings, including IND, IMPD, and BLA submissions.
• Evaluate and implement new technologies and platform approaches to improve formulation development capabilities for complex biologics.

Experience

• Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, or a related field with 10+ years of relevant industry experience; or M.S. with 12+ years of relevant experience.
• Deep expertise in formulation development for biologics, including monoclonal antibodies, bispecific antibodies, fusion proteins, or other large-molecule therapeutics.
• Strong hands-on experience with protein stability assessment, excipient selection, buffer optimization, and formulation screening for early- and late-stage development.
• Demonstrated experience developing formulations for high-concentration biologics and supporting subcutaneous and intravenous presentations.
• Familiarity with key challenges associated with complex protein therapeutics, including aggregation, fragmentation, oxidation, deamidation, viscosity, and interfacial instability.
• Experience working with external CDMOs and managing outsourced formulation and drug product development activities.
• Strong understanding of drug product manufacturing, fill-finish operations, container closure systems, and clinical supply requirements.
• Familiarity with regulatory expectations for formulation and drug product development in biologics programs.
• Excellent leadership, communication, and project management skills, with the ability to work effectively across multidisciplinary teams.
• Prior experience supporting regulatory submissions and health authority interactions is preferred.