Dianthus Therapeutics, Inc.

Project Manager

• Managing and tracking inter-disciplinary drug development programs
• Work closely with scientific leadership and subject matter experts
• Develop, implement and manage program strategy, operations and processes
• Establish strong partnership with scientific leadership to shape overall strategy
• Develop and maintain an integrated program plan encompassing key milestones
• Use meeting management best practices to drive cross-functional communication
• Proactively identify risks, gaps, and resource bottlenecks
• Lead the building of detailed program budgets
• Build and maintain strong working relationships with scientific lead and partners
• Develop & deliver impactful presentations
• Support the standardization of processes and communication

Director/Senior Director, Project Management

System Administrator

• Be the operational owner of our identity platform and access governance program, responsible for "who — and what — has access to what".
• Own the full identify lifecycle including automated provisioning/deprovisioning, and timely access revocation.
• Govern external identities: Entra External ID / B2B guest access, cross-tenant collaboration, access packages, and routine guest access reviews.
• Manage non-human identities: service principles, managed identities workload identities, and service accounts, including credential rotation, secret/certificate lifecycle, federated credentials.
• Administer ID platform; conditional access policies, new program rollouts, identity protection, risk-based access controls, and Privileged Identity Management (PIM).
• Design and operate SSO and SCIM provisioning integrations across the SaaS application portfolio.
• Lead periodic access reviews and recertification campaigns; maintain least-privilege and role-based access control (RBAC) models across M365, Azure, and SaaS systems.
• Manage privileged access: break-glass accounts, admin role assignments, just-in-time (JIT) elevation, and segregation of duties.
• Establish and enforce external collaboration governance: which tenants can collaborate with Dianthus, what data can be shared, how guest accounts are sponsored, and how they are decommissioned.
• Support IAM audit and compliance evidence collection.
• Support the response to identity-related security events in partnership with the cyber team.

System Administrator, Identity & Access Management

Supply Chain

• Execute high-value, end-to-end cold-chain logistics for biologics, focusing heavily on APAC, EU, and US based CRO/CMO/CDMO inventory management.
• Responsible for global transportation of drug substance, drug product, and various sample and stability materials.
• Maintain tight inventory control over large molecule drug substance, drug product, and other materials and components across a fragmented external manufacturing network.
• Anticipate and mitigate cross-border transit risks; ensure strict GxP and temperature compliance, optimize international transportation lanes, and streamline customs clearance.
• Build effective partnerships with key stakeholders across a range of functions, including CMC and GMP manufacturing, Analytical Development, Quality Assurance, Discovery, and external service providers, to ensure delivery of materials to support all product programs.
• Partner with 3PLs to ensure delivery timeline adherence and resolve customs holds and delays.

Supply Chain Logistics Manager

Director

• Lead the operational oversite of clinical external manufacturing (CMO) of Drug Product
• Develop and execute robust, phase-appropriate aseptic strategies for monoclonal and bispecific antibody drug products
• Experience managing CMOs and technology transfer of processes to external Contract Manufacturing Organizations
• Ensure strict adherence to cGMP requirements and global health authority expectations regarding aseptic controls
• Collaborate with formulation and device development teams to create stable, high-concentration liquid formulations
• Execute risk assessments and define process control strategies using QbD principles
• Troubleshoot manufacturing issues, analyze data, and implement process improvements
• Lead deviation investigations, CAPAs, and change controls
• Review CMC sections for regulatory submissions including INDs, IMPDs, and BLAs
• Serve as a Subject Matter Expert during regulatory agency interactions
• Manage vendor and CDMO relationships, ensuring alignment with project deliverables, budgets, and timelines

Associate Director/Director, Drug Product, CMC

• 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.

Director/Senior Director, Project Management

System Administrator, Identity & Access Management

Supply Chain Logistics Manager

Associate Director/Director, Drug Product, CMC

Associate Director, Biologics Formulation Development