Director of Process Development

6 hours ago


Stockholm, Stockholm, Sweden Planet Pharma Full time

About Our Work

We conduct extensive global clinical trials and preclinical therapies to advance and explore the potential of monoclonal antibodies.

Job Summary

  • We are seeking a Senior CMC professional to join our team in Sweden.

Main Responsibilities

  • This role will be responsible for ensuring timely supply of Drug Substance/Drug Product for non-clinical and clinical studies.
  • The successful candidate will provide comprehensive CMC support for internal projects from GLP toxicology through IND/CTA clinical programs to post-approval NDA/BLA.
  • They will collaborate with internal and external teams in analytical/quality control, quality assurance, and regulatory departments to resolve technical issues or deviations during cGMP production.
  • This position will manage contracts, pricing requests, and supply agreements related to drug substance and drug product manufacturing.
  • The candidate will support and review relevant CMC sections for regulatory submissions.
  • They will work closely with cross-functional teams to ensure smooth transitions between drug substance and drug product programs.

Key Requirements

  • A proven track record in cross-functional management, with the ability to lead diverse, complex projects and timelines successfully.
  • In-depth knowledge of US and EU CMC regulatory requirements for biologics tailored to different development phases.
  • Experience with technical transfers and managing complex development and manufacturing processes.
  • Previous experience managing CDMOs for outsourced manufacturing is ideal.
  • Experience in biologics manufacturing is required.


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