Dianthus Therapeutics, Inc. logo
Dianthus Therapeutics, Inc.

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

Associate Director/Director, Drug Product, CMC

DirectorDirectorFull TimeRemoteSeniorTeam 1-10Since 2017H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

3 days ago

Salary

0

Seniority

Senior

Bachelor Degree10 yrs expEnglish

Job Description

Associate Director/Director, Drug Product, CMC

Dianthus Therapeutics, Inc.

• 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

Job Requirements

  • 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

  • remote work
  • collaborative culture
  • professional growth opportunities

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