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Associate Director/Director, Drug Product, CMC
Dianthus Therapeutics, Inc.Associate Director/Director leading external manufacturing for CMC of drug products at Dianthus Therapeutics. Focusing on monoclonal antibodies and ensuring compliance with regulatory standards.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading clinical external manufacturing operations, ensuring compliance with cGMP standards, and executing aseptic strategies for monoclonal and bispecific antibody drug products. Proven ability to manage CMO relationships, conduct risk assessments, and author regulatory submissions.
Highest-signal resume keywords
Clinical External Manufacturing OversightAseptic Strategy DevelopmentCGMP ComplianceRegulatory Submission AuthoringCross-Functional Communication
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Drug Product CMC SupportProcess Control StrategiesRisk Assessment ExecutionDeviation InvestigationCAPA ManagementChange ControlProtein Stability KnowledgePrefilled Syringe HandlingIsolator/RABS TechnologiesSterile Manufacturing
Soft Skills
Strategic Problem-SolvingPeople Leadership
Industry Keywords
CGMP StandardsICH GuidelinesINDsIMPDsBLAsContract Manufacturing OrganizationsTechnology TransferFormulation DevelopmentHigh-Concentration Liquid FormulationsVendor Management
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- Bachelor of Science and 12 years or Master’s and 10+ years of experience in Chemical Engineering, Biochemistry, Pharmaceutics, or related scientific discipline
- 10+ years’ experience in drug product CMC support.
- Up to 5-10% of travel is required
- Deep understanding of protein stability, prefilled syringe handling, isolator/RABS technologies, and sterile manufacturing.
- Extensive knowledge of cGMP standards, ICH guidelines, and authoring BLAs for commercialization.
- Proven track record as a people leader with strong cross-functional communication and strategic problem-solving abilities.
Benefits
Comp & perks- remote work
- collaborative culture
- professional growth opportunities