Associate Director, Biologics Formulation Development
About Us
We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology – enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation – enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.
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 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, 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.