stillingsbetegnelse: Quality Control Scientist

jobbeskrivelse:
Join a dynamic and international company where everyone is responsible for delivering right on time as one team! The Department QC Chemistry is involved in analysis of samples from manufacturing to release of drug substances. Within this broad working area and with various drug substances we have a close collaboration with Analytical Development, Manufacturing, Up- and Downstream Development to gain control of all steps in the manufacturing processes. QC Chemistry is performing a broad variety of validation from clinical phase I/II through full validation clinical phase III/commercial. Everything we do, we do in close collaboration with our customers. 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. CMC offers CMC offers a dynamic workplace with good opportunities to work with a wide and varied range of tasks and challenges. You will be inaugurated in and have experience with the way the various departments in a "Contract Manufacturing Organization" (CMO), collaborate to achieve success. Exciting and challenging assignments will come to you in a steady stream, and you will very largely able to plan your day. CMC offers an informal and humorous working environment that is characterized by the fact that we think it is fun to go to work. We respect each other and our differences. CMC employees are flexible and take pride in working together to achieve goals - as one team. For further information regarding the position, please do not hesitate to contact Manager QC Chemistry, Iben Schildt Sørensen, telephone +45 2294 2949. We will process the applications as they arrive. Therefore please submit your application and CV as soon as possible and no later than May 20st, 2016. We tre

Arbejdsgiver Navn: CMC BIOLOGICS A/S

Arbejdsgiver telefonnummer: 70209470

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark