About the role
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 The Associate Director/Director of Drug Product CMC will lead the operational oversite of clinical external manufacturing (CMO) of Drug Product required to transition monoclonal antibodies (mAbs) and biotherapeutics into scalable, robust processes from Drug Substance to Drug Product stage. This role heavily centers on a solid understanding of Protein Chemistry, optimizing formulation and process parameters, overcoming shear stress and aggregation, and advancing prefilled syringe (PFS) and combination product delivery systems from late-stage clinical development, process performance qualification through commercial launch. This role will partner with Quality, Supply Chain, External Manufacturing and Regulatory CMC to manage technical risk and maintain continuity of product and process knowledge across external manufacturing networks. This is a unique opportunity to join a growing organization with an expanding pipeline, and to play an integral role in the global development of all programs. 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
