Dianthus Therapeutics, Inc. · 1 month ago
Director, Biologics Formulation Development
United States
Full-time
Remote
Director/Executive
10+ years expDianthus Therapeutics, Inc. is developing innovative therapies for patients with severe autoimmune diseases. The Director of Biologics Formulation Development will lead the formulation strategies for a new bispecific fusion protein program, focusing on protein stability and manufacturability.
PharmaceuticalBiotechnologyHealthcareBiopharmaHealth Care
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
Qualification
Required
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
Preferred
Prior experience supporting regulatory submissions and health authority interactions
Company
Dianthus Therapeutics, Inc.
Dianthus Therapeutics, Inc.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.36BKey Investors
5AM Ventures,Avidity Partners,Fidelity
2026-03-10Post Ipo Equity· $719M
2025-09-09Post Ipo Equity· $288M
2024-01-22Post Ipo Equity· $230M
Leadership Team
Marino Garcia
President & Chief Executive Officer, Board Member
Ryan Savitz
Chief Financial Officer
Recent News
2026-06-29
Company data provided by crunchbase