stillingsbetegnelse: Upstream Scientist for 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 team is responsible for two large scale mammalian GMP manufacturing lines and covers all process steps in upstream and downstream - from thaw of vial to final formulation of API. The single use bioreactor Line (2000-L SUB) will be expanded significantly over the next year, and this Team will be running the largest SUB facility in Europe. There will be unique opportunities for the right candidate to be responsible for introducing new products to this Line. The team manufactures API according to the CMC quality system following cGMP at all aspects of the daily work. The team is 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 Upstream 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 upstream processes working with shakers, cultibags, single use bioreactors, stainless steel bioreactors and clarification filtration. • Follow-up on ongoing production campaigns including client communication, 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, Chemical Engineering or similar. 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 bioreactors and cell culture. • Experience with installation and qualification of production equipment. • 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 t

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