Back to Job Search

Senior CMC Manager (m/f/x)

  • Location: Berlin
  • Salary: negotiable per year
  • Job Type:Permanent

Posted 11 days ago

  • Sector: Pharmaceutical
  • Contact: Claudia Gines Madrid
  • Contact Email: c.gines@sciproglobal.de
  • Start Date: asap
  • Expiry Date: 26 August 2022
  • Job Ref: RA_2022_13_1658927179

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.