stillingsbetegnelse: Scientist for Quality Control - Microbiology

jobbeskrivelse:
Join a dynamic and international company where everyone is responsible for delivering right on time as one team! The Department The Quality Control unit at CMC Biologics A/S consist of three teams; QC Bioassay, QC Chemistry and QC Microbiology (with 6 highly dedicated technicians and a scientist). QC Microbiology is responsible for microbiological analysis on API’s for clinical trials and commercials, Environmental monitoring in clean rooms, chemical/microbiological analyses on pharmaceutical water, and TOC (Total Organic Carbon) analysis on production rinse samples. The department has a close collaboration with; Manufacturing, QA, Up- and Downstream Development and Analytical Development to gain control of all steps in the manufacturing processes. Everything we do, we do in close collaboration with our customers. Tasks and Responsibilities The position requires expertise within TOC and LAL analyses and knowledge about microbiological analyses and clean room environment. You will be the responsible scientist for TOC and LAL analyses in the department and co-responsible for the microbiological analyses, where evaluation of results and generation of project related GMP documentation will be a natural part of your daily work. Gathering data for reports, writing deviations and constantly optimize procedure (SOP’s, TEQ’s ect.) ensure continuous compliance with cGMP with a LEAN mindset. A part of the job will be to give input to customer project teams, preparing for method validation (e.g. TOC and bioburden validation for clinical phase I/II through full validation) and commercial licensing. Through internal and external audits you can expect to build great expertise within these areas by interacting with our many different international customers. Your Profile The ideal candidate holds a MSc or PhD degree in Pharmacy, Microbiology or other relevant field and has most likely knowledge in several of the following qualities: • Experience in pharmaceutical water testing both chemical and microbiological analyses. • Commercial GMP production and/or with production for late stage clinical trials. • Solid microbiological understanding and knowledge . • Solid knowledge on environmental monitoring and qualification of clean rooms. • Validation/qualification of microbiological methods and equipment. • Experience with writing validation protocol, validation report, SOPs. • Regulatory inspections e.g. DMA, FDA and customer audits (internal and external audits). • General knowledge about regulatory requirement for LAL, TOC and microbiological analyses as well for classified production areas . • Knowledge of GMP systems according to European and US regulatory guidelines. • Production of biotechnological products and APIs. • You like to share your knowledge and communicate openly and professionally both internally and with external customers. • You take responsibility for your personal assignment and thrive at reaching them in a timely manner. • 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

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