Associate Director, Biopharmaceuticals

6 hours ago


Stockholm, Stockholm, Sweden Planet Pharma Full time

Join Our Team

We are a growing innovative biotech company with a focus on advancing and exploring the potential of monoclonal antibodies.

Job Overview

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

Key Responsibilities

  • This role will be responsible for providing comprehensive CMC support for internal projects from GLP toxicology through IND/CTA clinical programs to post-approval NDA/BLA.
  • The successful candidate will ensure timely supply of Drug Substance/Drug Product for non-clinical and clinical studies.
  • 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.

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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