Dianthus Therapeutics, Inc.
Director, Drug Substance and Early Development
Dianthus Therapeutics, Inc., Waltham, Massachusetts, United States, 02254
Director, Drug Substance and Early Development
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Director, Drug Substance and Early Development
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Dianthus Therapeutics, Inc.
About Us We are developing potentially best‑in‑class therapies for patients with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is engineered with extended half‑life, improved potency, and high selectivity for the active C1s complement protein, enabling less frequent and more convenient subcutaneous injections. Our second clinical candidate, DNTH212, is a first‑in‑class bifunctional inhibitor targeting Type 1 IFN suppression and B‑cell modulation, providing potential for improved clinical outcomes and patient‑friendly, self‑administered subcutaneous injections. To learn more, visit www.dianthustx.com and follow us on LinkedIn.
About the Role As the Director of Drug Substance and Early Development, you will lead early development activities for our clinical‑stage biologics pipeline, including monoclonal antibodies and fusion proteins. This high‑impact, hands‑on role will advance our drug substance development strategy—formulation, cell line development, bioreactor scale‑up, and tech transfer—to support clinical and future commercial manufacturing.
Key Responsibilities
Lead MSAT activities for monoclonal antibodies and fusion proteins, from early development through clinical manufacturing.
Oversee cell line development, clone selection, and characterization in collaboration with internal teams and external partners.
Design and optimize bioreactor processes (shake flask to pilot scale) to ensure scalability, robustness, and regulatory compliance.
Drive formulation development strategies for early‑phase programs, ensuring compatibility with downstream processing and stability requirements.
Collaborate cross‑functionally with Analytical Development, Downstream Process Development, Quality, Regulatory, and Clinical Supply teams.
Serve as technical SME during tech transfer to CDMOs and during regulatory interactions.
Author and review CMC sections of regulatory filings (IND/IMPD/BLA).
Evaluate and implement new technologies to enhance upstream development capabilities.
Experience
PhD in Biochemical Engineering, Cell Biology, Biotechnology, or related field with 10+ years of relevant industry experience; or M.S. with 12+ years.
Proven track record in upstream process development, cell line development, and bioreactor scale‑up for biologics.
Hands‑on experience with monoclonal antibodies and/or Fc fusion proteins is required.
Strong understanding of formulation development for early‑phase biologics.
Experience working with CDMOs and managing outsourced development/manufacturing activities.
Familiarity with regulatory requirements for early‑ and late‑stage biologics development.
Excellent leadership, communication, and project management skills.
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Director, Drug Substance and Early Development
role at
Dianthus Therapeutics, Inc.
About Us We are developing potentially best‑in‑class therapies for patients with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is engineered with extended half‑life, improved potency, and high selectivity for the active C1s complement protein, enabling less frequent and more convenient subcutaneous injections. Our second clinical candidate, DNTH212, is a first‑in‑class bifunctional inhibitor targeting Type 1 IFN suppression and B‑cell modulation, providing potential for improved clinical outcomes and patient‑friendly, self‑administered subcutaneous injections. To learn more, visit www.dianthustx.com and follow us on LinkedIn.
About the Role As the Director of Drug Substance and Early Development, you will lead early development activities for our clinical‑stage biologics pipeline, including monoclonal antibodies and fusion proteins. This high‑impact, hands‑on role will advance our drug substance development strategy—formulation, cell line development, bioreactor scale‑up, and tech transfer—to support clinical and future commercial manufacturing.
Key Responsibilities
Lead MSAT activities for monoclonal antibodies and fusion proteins, from early development through clinical manufacturing.
Oversee cell line development, clone selection, and characterization in collaboration with internal teams and external partners.
Design and optimize bioreactor processes (shake flask to pilot scale) to ensure scalability, robustness, and regulatory compliance.
Drive formulation development strategies for early‑phase programs, ensuring compatibility with downstream processing and stability requirements.
Collaborate cross‑functionally with Analytical Development, Downstream Process Development, Quality, Regulatory, and Clinical Supply teams.
Serve as technical SME during tech transfer to CDMOs and during regulatory interactions.
Author and review CMC sections of regulatory filings (IND/IMPD/BLA).
Evaluate and implement new technologies to enhance upstream development capabilities.
Experience
PhD in Biochemical Engineering, Cell Biology, Biotechnology, or related field with 10+ years of relevant industry experience; or M.S. with 12+ years.
Proven track record in upstream process development, cell line development, and bioreactor scale‑up for biologics.
Hands‑on experience with monoclonal antibodies and/or Fc fusion proteins is required.
Strong understanding of formulation development for early‑phase biologics.
Experience working with CDMOs and managing outsourced development/manufacturing activities.
Familiarity with regulatory requirements for early‑ and late‑stage biologics development.
Excellent leadership, communication, and project management skills.
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