Quality Control Scientist

pracovná oblasť

Odborníci v oblasti výpočtovej techniky, strojárstva a vedy
   Fyzika, chémia a príbuzné profesie
        Chemici

NÁPLŇ PRÁCE:

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. Everything we do, we do in close collaboration with our customers. Tasks and Responsibilities The position requires a broad technical expertise and ability to troubleshoot on chemical methods, especially HPLC, iCE280 and CE-SDS. 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 3 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 analytical experience with SE-, IEX- and RP-HPLC, iCE280 and CE-SDS analysis • Technical experience in protein analytics testing • Good understanding 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 September 20th, 2015. About CMC Biologics A/S CMC Biologics (CMC) is a global Contract Manufacturing Organization (CMO) with three biomanufacturing facilities in Europe and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services. CMC Biologics also offers non-exclusive license to CHEF1™, a proprietary CHO cell line development platform. CHEF1 delivers stable, high-titer, production-quality cell lines in optimized time frames. It is the foundation of CMC Biologics’ innovative approach to cell line and process development. Visit http://www.cmcbiologics.com to learn why CMC Biologics is a World Leader in process development and contract manufacturing.

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source: https://www.ec.europa.eu/eures

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