stillingsbetegnelse: Technician in Manufacturing

jobbeskrivelse:
Join a dynamic and international company where everyone is responsible for delivering right on time as one team! We are hiring a technician to operate Upstream and Downstream processes in our GMP facility. The department You will be part of a team within Manufacturing consisting of 15 professionals distributed on scientists and technicians. The team is working with several different processes by campaign manufacturing of API based on cell culture technology. The team is responsible for two Manufacturing lines and covers all process steps in upstream and downstream - from thaw of vial to final formulation of API. The manufactured drug substances range from technical through all phases of clinical material. The team therefore operates according to the CMC quality system following cGMP at all aspects of the daily work. The team is working with cell culture technology and operates both large-scale steel bioreactors and single-use (disposable) bioreactors up to 2000 L scale. In purification we utilize technology such as a variety of disposable filtration pods, Bioprocess chromatography systems and TFF’s. Responsibilities and tasks The role as technician requires that you are able to: • Participate in executing processes according to GMP policies at CMC. This includes: o Daily operation of upstream or downstream processes at different scales. o Generation of GMP data. o Weekend rotation and on-call duties. Shiftwork during DSP production campaigns. • Participate in maintaining equipment and facilities in compliance with CMC GMP policies. • Contribute in implementation of new processes in close cooperation with department scientists. • Work with our engineering and validation teams regarding implementation and qualification of new equipment, control, calibration and maintenance of existing equipment. Experience and competencies You have a technical background and you bring some of the following competencies and experiences: • Cultivation of mammalian cell cultures in production scale and experience with handling of bioreactors. • Hands on experience with chromatography and continuous filtrations (TFF, UF, DF, MF, etc.), • Experience with cGMP. • You have a positive attitude and think proactively. • You are dynamic with the ability to operate and manage changes. • You are a goal oriented team player, a good collaborator and have good communication skills. CMC is an international organization with sites both in Europe and the US and our company language is English. It is therefore necessary that you are capable of speaking and writing English. CMC offers CMC offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges in Manufacturing. You will get insight into and experience with 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 please contact Manufacturing Manager, Rejhan Klica: +45 2294 3073. We will process the applications as they arrive. Therefore please submit your application and CV as soon as possible and no later than January 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, stan

Arbejdsgiver Navn: CMC BIOLOGICS A/S

Arbejdsgiver telefonnummer: 70209470

Job kort beskrivelse:
Undervisning og forskning på universiteter og højere læreranstalter

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark