Quality Control Specialist | CMC Biologics Copenhagen Area, Capital Region, Denmark

Job Details:
Tasks and Responsibilities
The position requires technical expertise and ability to troubleshoot on chemical methods, especially HPLC, iCIEF and CE -SDS, and expertise within (U)HPLC equipment. A major part of the job will be representation of QC in customer project teams, preparing for method validation (clinical phase I/II through full validation) and commercial licensing. You will have contact with customers with diverse backgrounds and cultures; for that reason good communication skills are essential. Cooperation with the customers will at times be very close, and will have consultative character in order to solve customer challenges together. Design and implementation of test method validations, including report writing and review, along with managing projects are also important parts of the job. On a daily basis the tasks also include improvement of laboratory GMP systems according to European and US regulatory guidelines.
Your Profile
The ideal candidate holds a MSc or PhD degree in Chemistry or relevant area and has minimum 5 years of work experience in analytical development or quality control. In addition we expect you to bring some of the following experience and characteristics:
•Working and troubleshooting experience with SE-, IEX- and RP-HPLC, iCIEF and CE-SDS analysis.
•Experience and knowledge with (U)HPLC equipment and Chromeleon software.
•Technical experience in protein analytics testing.
•Knowledge of protein structure and biochemistry.
•Experience with writing validation protocol, validation report, SOP’s is an advantage.
•Knowledge of GMP systems according to European and US regulatory guidelines is an advantage.
•You like to share your knowledge and communicate openly and professionally both internally and with external customers.
•The ability to handle multiple tasks simultaneously without losing track.
•You enjoy working in a high pace and be challenged in a busy business.
•You are a team player combined with the ability and desire to work independently.
•Excellent communication, presentation and interpersonal skills.
•Ability to apply organizational skills to systems and efficiency improvement.
CMC has international customers and our company language is English. It is therefore vital to be fluent in written and spoken English...
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