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 is expanding and we are looking for new colleagues. The department 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 and CMC Biologics holds exciting customer projects from Phase I to Commercial stages. 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 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 QC at regular 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, Process Transfer and QA. The main tasks are as follow: • Write and review cGMP documents (e.g. test methods, general procedures). • Review and approve analytical results for cGMP compliance and scientific content. • Assist in analytical methods transfer from Analytical Development or customers into QC • Plan and supervise method validations according to ICH guidelines. • Represent Quality Control in various customer projects (QC project coordinator) including presenting data, activity status and solutions to customers. • Drive Initial Laboratory Investigations and deviation reports related to QC activities. • Troubleshooting and scientific support in bioanalytical methods such as ELISA assays (quantitative and potency assays), protein electrophoresis (SDS-PAGE, IEF), protein concentration determination. Your Profile The ideal candidate will possess an academic degree in Biochemistry or other related fields, practical and theoretical knowledge of bioanalytical techniques such as ELISA and protein electrophoresis (SDS-PAGE, IEF). Industrial experience from a cGMP environment is a plus. 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 • Good analytical and troubleshooting skills. • 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 p

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