Senior CMC Manager (m/f/x) | Pharma | Berlin Area
In this role, your main focus will be coordinating monoclonal antibody manufacturing activities (upstream and downstream workflows) for clinical trials and the upcoming market launch. As a Senior CMC Manager you will be also responsible for the preparation for market production of a monoclonal antibody & for project management activities.
What are your tasks as "Senior CMC Manager (m/f/x)"?
- Process coordination with contract manufacturers
- Scientific evaluation of results from product characterization, validation and stability studies
- Review and release of manufacturing documentation, logs and reports
- Responsible for GMP-compliant storage and shipping of cell banks, drug substance and drug product
- Support in the creation of regulatory documents
- Perform risk assessments for process related changes
- Identification of contract service providers
- Support contract drafting
- Coordination of manufacturing requirements (e.g. production slots, logistics) with project timelines
- Coordination of manufacturing and documentation activities with external and internal stakeholders
- Cooperation in the workgroups concerning the CMC documentation
- Support of registration projects concerning CMC questions
- CMC Subject matter expert and point of contact for colleagues
What profile is required as "Senior CMC Manager (m/f/x)"?
- Experience in in biological drug manufacturing preferably in pharmaceutical or biotechnological companies
- Experience in upstream and downstream manufacturing of biologics; experiences in antibody manufacturing preferred
- Advanced knowledge of GMP requirements for biological drug manufacturing, including GMP regulations (cGMP, FDA)
- Project management skills
- Academic Background in Life Sciences (e.g., Pharmacy, Chemistry, Biology etc.)
- Professional working proficiency in English, at least B2 German
About our client:
Our client is a highly innovative, clinical-stage biopharmaceutical company based in the Berlin Area. It specializes in preserving vascular integrity in life-threatening conditions as well as developing precision medicine and is committed to save the lives of critically ill patients with limited treatment operations.