Dianthus Therapeutics
Biotechnology
AssociateDirector,BiologicsFormulationDevelopment
Neural analysis suggests this role is
optimal for Director candidates.
“Associate Director, Biologics Formulation Development at Dianthus Therapeutics. Skills: Formulation Development, Biologics, Bispecific Antibodies, Protein Stability. Lead formulation development strategy. Design and execute studies”
Industry & Context.
solving complex developability challenges
What They're Looking For.
Must Have
Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, or a related field with 8+ years of relevant industry or M.S. with 10+ years of relevant experience, Deep expertise in formulation development for biologics, hands-on experience with protein stability assessment, excipient selection, buffer optimization, formulation screening for early- and late-stage development, Demonstrated experience developing formulations for high-concentration biologics, supporting subcutaneous and intravenous presentations, understanding of drug product manufacturing, fill-finish operations, container closure systems, clinical supply requirements, Excellent leadership, communication, project management skills
Nice to Have
Prior experience supporting regulatory submissions, health authority interactions
What You'll Do.
Lead formulation development strategy
Design and execute studies
Develop liquid and lyophilized formulations
Lead excipient screening
Drive high-concentration formulation development
Provide technical leadership
Serve as formulation subject matter expert
Identify formulation-related risks
Evaluate and implement new technologies
How You'll Work.
Team & Collaboration
work closely with internal teams; external partners; Partner closely with Analytical Development; Collaborate with Drug Substance; Process Development; Quality; Regulatory; Clinical Supply; external CDMOs; work effectively across multidisciplinary teams
Communication Scope
communication skills
Process & Methodology
project management skills
Full Job Description
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 chal
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