Chief CMC Officer

7 days ago


Cape Town, Western Cape, South Africa Modex Full time
About the Role

We are seeking an experienced and highly motivated individual to lead our CMC team. As Director / Senior Director of CMC, you will play a pivotal role in ensuring the seamless progression of our diverse pipeline of biologics candidates from Research to IND enabling work and through clinical development.

Key Responsibilities:
  • CMC Technical Leadership: Develop and implement comprehensive CMC strategies and oversee CMC activities for assigned projects, including biologics and lipid-based delivery modalities, ensuring alignment with regulatory standards and company objectives.
  • CDMO Management: Oversee execution of CMC work at CDMO network worldwide from cell line development to bulk drug substance, drug product manufacturing, shelf life and readiness for clinical supply.
  • Regulatory Submissions: Prepare and/or review CMC sections of regulatory submissions including background documents, INDs, IMPDs, ensuring compliance with regulatory requirements and guidelines.
  • Cross-Functional Collaboration: Work collaboratively with Research, Clinical Development, Regulatory Affairs, and other departments to ensure cohesive advancement of projects.


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