Director, Biologics Formulation Development

About Us

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.

This role will play a critical part in establishing robust formulation and drug product strategies for a complex biologic modality, including buffer selection, excipient screening, high-concentration formulation development, and compatibility with manufacturing and delivery systems. The ideal candidate will bring deep expertise in biologics formulation, especially for bispecific antibodies, fusion proteins, or other large-molecule therapeutics, and will work closely with internal teams and external partners to support clinical and future commercial development.

This is a high-impact, hands-on role at a growing biotech, ideal for a leader who enjoys solving complex developability challenges, driving cross-functional execution, and partnering closely with CDMOs and internal technical teams. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

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.
• Identify formulation-related risks early and develop mitigation strategies to support program timelines and long-term product quality.
• 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.