stillingsbetegnelse: Scientists - Oral Protein Formulation

jobbeskrivelse:
- Pilot Plant Scientist - Denmark - Måløv Our growth is your opportunity Being part of Novo Nordisk Research & Development means working at one of the world's largest and most successful biopharmaceutical companies. Our R&D organisation is vital to Novo Nordisk's continued growth and we always welcome talented people who would like to grow with us. As Novo Nordisk is developing break-through solid dosage formulations of insulin and GLP-1, we are expanding our clinical late phase organisation. Having received positive phase II results the future Pilot facility is under construction and correspondingly our new department, OFP Manufacturing Development, is being established.That is why we are looking for scientists ready to take up the responsibility for equipment qualification, environmental monitoring and utility related to the manufacturing development and pilot facility. About the department The department was established in September 2014 and will by August 2015 employ 85 colleagues grouped in 6 teams. The purpose of the department is deliverables for the late stage clinical trial and preparation of filing documentation. This means qualifying the manufacturing equipment, setting and validating the manufacturing process. Also the department will be operating the late phase facility. The job You will play an absolute key role in our business critical efforts to ensure and maintain the facility’s license to operate. Across your tasks and projects you therefore will have a close collaboration with different team members and other departments in OPF, ensuring that our project time lines and deliverables are met.As a chemist your responsibility could include equipment qualification, environmental monitoring or validation of the utility related to our Pilot facility.The tasks will amongst other be establishment of URS, protocols, data analysis and reports. Also development of standard Operating Procedures (SOP´s) will be in scope.You will get the opportunity to participate in all phases of projects related to Oral Pilot Plant processes. Still, your primary focus will be the challenges related to validation/qualification of facilities and equipment for GMP use. A vital part of your job is to ensure that equipment and facilities are in compliance with cGMP standards. Qualifications You hold a Master degree in engineering, pharmacy or similar. Your previous employment has provided you with solid experience within qualification/validation of pharmaceutical production equipment or facilities. You have a strong quality mind set, overview and keen eye for details. If you also have experience with SDF manufacturing, it is a major advantage but not a prerequisite for applying.You thrive on handling multiple tasks simultaneously in a dynamic environment where everyone contributes to the team’s success with a positive attitude to challenges, dedication and a flexible attitude towards creating considerable results. At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and change their lives. By working with us you will have the opportunity to do the same in a global business environment. Contact For further information please contact Anders Bæk at +45 3079 2457 or Thomas Østergaard at +45 3075 3769. Deadline 12 March 2015.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark