Job Description
Specialist, QC CMC Biologics
Do you want to join our global CMC Biologics Quality Control team? And are you eager to work in an international setting where empowerment and cross functional collaboration skills are key? Then you might be our new Specialist!
Your new role
As our Specialist, you will be:
Technical lead and subject matter expert for Quality Control activities with focus on drug productWorking closely with contract manufacturing organizations (CMOs) to plan, implement, and finalize QC relevant activities, e.g., sampling plans, specifications, Certificate of Analysis, stability studies, method validation etc.Reviewing and approving testing data, protocols, reports, and other documents for studies performed internally and at contract laboratoriesCollaborating within project teams including Process Development, Process Science and Validation, Analytical Development, Quality Assurance, an...