stillingsbetegnelse: Downstream Scientist in Manufacturing

jobbeskrivelse:
Join a dynamic and international company where everyone is responsible for delivering right on time as one team! CMC Biologics is a Contract Manufacturing Organization producing Active Pharmaceutical Ingredients (API) for different biopharmaceutical companies worldwide. The Copenhagen facility is capable of large scale manufacturing of API using cell culture or microbial technology. Our multiproduct facilities offer you the opportunity to work in a state-of-the-art environment with modern equipment and the newest technologies. You will experience a dynamic working environment with a great variety of tasks, and an environment where cGMP production never becomes routine. 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 teams is responsible for two manufacturing lines and cover 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 also responsible for implementing and starting-up of new projects collaborating internally and with customer delegates on producing Master Production Records and ensuring equipment and facility capabilities are matching the requirements of the new process. Tasks and Responsibilities Depending on your education and level of experience you will be responsible for the following tasks: • Project responsible scientist (PRS) for assigned projects: o Downstream representative in a project group consisting of PRS’s from different departments that performs cross-functional work to ensure a successful project execution and communication with international clients. • Implementation of new processes in close collaboration with our Project Transfer team and Development teams. • Write quality documents such as Master Production Records and other technical procedures. • Planning and coordination of manufacturing campaigns. • Operation of purification processes working with GE Bioprocess skids, TFF systems and virus filtration systems. o Purification processes typically require shift work which also includes working during weekends. • Follow-up on ongoing production campaigns including review and approval of batch records, troubleshooting, handling of deviations and CAPA’s. • Production and process optimization. Your Profile You hold an MSc in Biotechnology, Chemistry or in a similar area. In addition we expect experience in some of the following areas: • Knowledge of the bio-pharmaceutical industry. • Experience working under ICH Q7. • Practical experience and solid theoretical knowledge of chromatography, columns and resins as well as TFF membrane technology. • Good understanding of software for chromatography, preferably unicorn. • You are dynamic with the ability to operate and manage changes with a positive attitude. • You have the ability to keep the overview and prioritize even when you are busy. • 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 vital to be proficient in written and spoken English. CMC offers CMC offers a dynamic work 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. CMC offers you the possibility to develop professionally and to influence the direction of you career. Exciting and challenging assignments will constantl

Arbejdsgiver Navn: CMC BIOLOGICS A/S

Arbejdsgiver telefonnummer: 70209470

Job kort beskrivelse: Arbejde inden for kemi

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark