stillingsbetegnelse:
Scientist for QC Chemistry 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 controlling raw materials, running various analytical methods, planning and executing stability programs and validating various analytical procedures according to ICH guidelines. Within this broad working area and with various biopharmaceuticals QC have a close collaboration with departments across the organization to gain control of all steps in the manufacturing processes. Tasks and Responsibilities As a Scientist in QC Chemistry, you will be responsible for the planning and completion of several projects within deadlines together with your colleagues in the group. You will work with customers from various backgrounds and cultures. The collaboration is a partnership where you will work closely with the customers to solve their challenges together. On a daily basis the tasks also include improvement of laboratory GMP systems according to European and US regulatory guidelines. Key tasks are: • Deliverance of scientifically sound and cGMP compliant raw material documents and analytical results. Involvement in operating the raw material program, including risk assessments and creating qualification protocol/reports • Oversight of sampling, as well as internal and outsourced testing. • Preparing for analytical method validation (clinical phase I/II through full validation) and commercial licensing Your Profile The ideal candidate holds a MSc or PhD degree in Biochemistry, Chemistry or relevant area and has minimum 3 years of work experience within raw materials and/or analytical development or quality control. In addition we expect you to bring some of the following experience and characteristics: • Technical experience within raw materials for cGMP production for phase I/II trough commercial licensing raw material testing. • Experience setting specifications for compendial and non-compendial raw materials • Ability to oversee a raw material program supporting multiple products and processes. • Write and review cGMP documents (e.g. raw material specifications, test methods, general procedures). • Review and approve analytical results for cGMP compliance and scientific content. • Represent Quality Control in various customer projects as a QC project coordinator • Working and analytical experience with SE-, IEX- and RP-HPLC, iCE280 and CE-SDS analysis is an advantage • You are an experienced multi-tasker and 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. 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 to work. We respect each other and our differences. CMC employees are flexible and take pride in working together to achieve goals - as one team. For further information regarding the position, please do not hesitate to contact Manager QC Chemistry, Iben Schildt Sørensen, telephone +45 2294 2949. We will process the

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