Director of Process Development
6 hours ago
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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