stillingsbetegnelse: Principal Scientist for UPLC and CE Development

jobbeskrivelse:
Join a dynamic and international company where everyone is responsible for delivering right on time as one team! We are seeking a Principal HPLC Scientist to join the Analytical Development (AD) Department at CMC Biologics A/S (CMC). CMC is a Contract Manufacturing Organization with facilities in Denmark and USA and with customers all over the world. The department The AD Department is responsible for implementation, transfer and development of analytical procedures, analytical support to upstream and downstream, characterization of products, testing Engineering batches for production and the transfer of analytical methods to QC for validation. Projects range from early pre-clinical development through all phases of clinical development all the way to commercial supply. AD is also involved in cross functional project groups and implementation of new analytical technologies and techniques. The work environment in our department is very informal. There is constant collaboration across the organization, and all employees have a professional and flexible attitude towards their work. The department consists of 17 dedicated and highly competent scientists and technicians working in two areas e.g. HPLC and bioassay. The team is in close contact with our counterparts in our Seattle facility. Responsibilities and tasks As a Principal Scientist you will be responsible for multiple analytical development projects as an AD coordinator, and participate in multi-disciplinary project teams including upstream, downstream, process transfer, QA, QC and manufacturing scientists working in close collaboration with the clients’ scientific teams. You will get the opportunity to work with a broad range of diverse products in different clinical stages and to use you skills in a very cross functional setting and interactive environment. The job includes: • Planning and coordination of implementation, transfer and development of new analytical procedures. • Representation of AD in cross functional project teams. • Verbal and written reporting to clients. • Approval and reporting of analytical results to internal and external customers. • Defining product specification together with QC and the client. • Transfer of analytical procedures to QC. • Strategic technology development. Experience and competencies The ideal candidate holds a PhD in Protein Chemistry, Biochemistry, Biochemical or Chemical Engineering, or related scientific/technical background. In addition to that you have: • A minimum of 5-8 years relevant experience from the industry. • Demonstrated strong expertise within development of analytical procedures. • Demonstrated strong cross-functional expertise and understanding of how analytical methods do best capture/monitor potential impacts to the quality and functional activity of proteins during the production process. • A solid understanding of biopharmaceutical manufacturing. • Experience in working with development of analytical procedures in the area of UPLC and CE. • Good interpersonal and communication skills. • Excellent English written and oral communication skills. On a personal level we expect you to: Be a high performing team player and to be ambitious on behalf of yourself and the company. You master the balance between speed of execution and quality of work. You embrace change and enjoy a rapid pace of work in a positive, can-do attitude and with a good sense of humor. You are experienced with working cross-functionally and internationally. CMC offers CMC offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges. 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 extent be able to plan your daily work yourself. CMC offers an informal working en

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