stillingsbetegnelse:
Scientist for QC Bioassay in our Quality Control Department

jobbeskrivelse:
Join a dynamic and international company where everyone is responsible for delivering right on time as one team! The Department The QC department at CMC Biologics consists of three functional groups; QC Bioassay, QC Chemistry, and QC Microbiology. The QC groups are responsible for supporting the production of new biopharmaceuticals by running various analytical methods, planning and executing stability programs and validating various analytical procedures according to ICH guidelines. The work is conducted under cGMP. Tasks and Responsibilities As a Scientist in QC Bioassay, you will be responsible for delivering scientifically sound and cGMP compliant analytical results and documents, plan and complete various projects within deadlines in close collaboration with your 10 colleagues in the group and assist the whole QC department with your professional expertise. You will also have direct contact with external customers and represent CMC at customer meetings. You will work closely with scientists in the other analytical departments in particular in Analytical Development. As Scientist and QC coordinator in various customer projects you will also have close collaboration with colleagues in Manufacturing and QA. The main tasks are as follow: • Write and review various cGMP documents. • Review and approve analytical results for cGMP compliance and scientific content. • Plan and execute method validations according to ICH guidelines. • Represent Quality Control in various customer projects (QC project coordinator). • Perform Initial Laboratory Investigations (ILI) and write deviations (DIR). • Scientific support in analytical methods within ELISA, SDS-PAGE, IEF, and Bioassay area. Your Profile The ideal candidate will possess an academic degree in Biochemistry or other related fields, have industrial experience from a cGMP environment, practical and theoretical knowledge of analytical techniques such as ELISA, SDS-PAGE, IEF, and Bioassays. In addition we expect you to bring some of the following experience and characteristics: • A flexible, dynamic and excellent team player who is fluent in English • Good communication skills and the ability to ensure and maintain solid cross-functional collaborations • A service-minded attitude to meet customer requests in a positive and professional way • Focus on meeting deadlines while ensuring high quality • A person with a good sense of humor who can plan and accomplish your work independently and efficiently • A person who can handle multiple tasks in a busy environment with a positive and constructive attitude CMC offers CMC offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges. You will get insight into and experience the way the various departments throughout a Contract Manufacturing Organization interact in order to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extend be able to plan your daily work yourself. CMC offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. CMC’s employees have a flexible attitude and we help each other to reach deadlines together as one team. For further information regarding the position, please do not hesitate to contact Manager QC Bioassay, Rita Olofsson, Tel: +45 2294 3016. We will process the applications as they arrive. Therefore please submit your application and CV as soon as possible and no later than October 16th, 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 turnk

Arbejdsgiver Navn: CMC BIOLOGICS A/S

Arbejdsgiver telefonnummer: 70209470

Job kort beskrivelse:
Arbejde inden for biologi, botanik, zoologi og beslægtede områder

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark