Biotech Senior CMC Leader

11 hours ago


Stockholm, Stockholm, Sweden Planet Pharma Full time
About the Role

At Planet Pharma, we are seeking a highly experienced Senior CMC Professional to join our team. The ideal candidate will have a strong background in biologics development and regulatory affairs.

Key Responsibilities:
  • CMC Support: Provide comprehensive support for internal projects from GLP toxicology through IND/CTA clinical programs to post-approval NDA/BLA.
  • Supply Chain Management: Ensure timely supply of Drug Substance/Drug Product for non-clinical and clinical studies.
  • Troubleshooting and Collaboration: Collaborate with internal and external teams to resolve technical issues or deviations during cGMP production.
  • Contract Management: Manage contracts, pricing requests, and supply agreements related to drug substance and drug product manufacturing.
  • Regulatory Submissions: Support and review relevant CMC sections for regulatory submissions.
Requirements:

To be successful in this role, you will need:

  • Cross-Functional Management Experience: Proven experience in leading diverse, complex projects and timelines successfully.
  • Regulatory Knowledge: In-depth knowledge of US and EU CMC regulatory requirements for biologics, tailored to different development phases.
  • Technical Transfer Expertise: Experience with technical transfers and managing complex development and manufacturing processes.
  • CDMO Management: Previous experience managing CDMOs for outsourced manufacturing is highly desirable.
  • Biologics Manufacturing: Experience in biologics manufacturing is essential.

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