Dianthus Therapeutics, Inc. logo
Dianthus Therapeutics, Inc.

Unlocking the full potential of complement therapeutics through the power of selectivity.

Associate Director, Biologics Formulation Development

DirectorDirectorFull TimeRemoteSeniorTeam 1-10Since 2017H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

3 days ago

Salary

0

Seniority

Senior

Postgraduate Degree8 yrs expEnglish

Job Description

Associate Director, Biologics Formulation Development

Dianthus Therapeutics, Inc.

• 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.

Job Requirements

  • 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.

Benefits

  • Flexible working arrangements
  • Professional development opportunities

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