
Chief Development Officer
4 days ago
We are proud to partner with Planet Pharma, a pioneering biotechnology company at the forefront of advancing monoclonal antibodies, particularly in transplantation and autoimmunity research. Their innovative immune-modulating strategies involve conducting extensive global clinical trials and exploring new preclinical therapies.
The company is seeking an experienced Senior CMC Professional to join their team at their site in Sweden.
Main Responsibilities:- Provide comprehensive support for internal projects, encompassing GLP toxicology through IND/CTA clinical programs, post-approval NDA/BLA, and ensuring timely supply of Drug Substance/Drug Product for non-clinical and clinical studies.
- Collaborate with internal and external teams in analytical/quality control, quality assurance, and regulatory departments to resolve technical issues or deviations during cGMP production.
- Manage contracts, pricing requests, and supply agreements related to drug substance and drug product manufacturing.
- Support and review relevant CMC sections for regulatory submissions.
- Work closely with cross-functional teams to ensure smooth transitions between drug substance and drug product programs.
- Build and maintain strong working relationships with internal stakeholders to meet internal goals and objectives.
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