stillingsbetegnelse: Team leader in Biopharm Cultivation

jobbeskrivelse:
- Research & Development - Denmark - Bagsværd Do you have an interest in managing a highly dedicated team of technicians and scientists in an API pilot production facility and do you know how to make people follow you? If yes, then we have the opportunity for you! About the department In Chemistry, Manufacturing and Control (CMC) Active Pharmaceutical Ingredient (API) Cultivation Pilot plants we are responsible for the production of new biopharm Active Pharmaceutical Ingredient used for clinical trials in Novo Nordisk A/S. In the biopharm portfolio there are a number of new haemophili product candidates but also products that could have an impact on the diabetes segment. All products in the department are produced by mammalian cell cultivation. The department consists of 30 skilled and dedicated employees divided into two teams: Cultivation team and Recovery team. The pilot production facility was established and started production in March 2013 and is based on single-use production technology. Even though the department is fairly new, we constantly focus on optimizing our facility and expanding the SU-concept and applications in and out of our department. The position As Team Leader you will be responsible for a team of 12 employees in our Recovery team. The team is responsible for performing the first purification step after cell culture harvest, virus inactivation and shipment of the product to further purification. The first step is based on a column capture step using Äkta bioprocess system with unicorn software. Part of your responsibility is to assure compliance according to Good Manufacturing Practice (GMP), meaning assuring that all procedures are followed. Deviations from the standard procedures are handled in non-conformity reports and batch documentation is handled in flow to assure low lead times for Quality Assurance approval of batches. Besides Good Manufacturing Practice productions, we also test new processes and equipment in the pilot facility. The overall objective is Good Manufacturing Practice implementation of new production techniques and technologies which increases yields, improves quality or even increases production capacity. In the position there will be high degree of interaction with other stakeholders e.g. Alignment with our quality organization to insure compliance and timely delivery of quality documents, coordination with support department to insure coordination of e.g. equipment calibration, qualification and department maintenance. There is a high degree of collaboration with development departments to insure robust technology- and process transfer to the pilot but also the post-batch evaluation is important to discuss possible optimization projects.Through the management team you will be part of setting the overall direction of the department. This will be the place where you will have the chance to lead the way and be a role model in a LEAN culture environment. We expect you to be ready to challenge, set direction and the right standards for the team to insure we achieve our goals. Qualifications You hold a degree in pharmacy, chemical engineering or similar. You are expected to have a scientific background within Active Pharmaceutical Ingredient and/or Drug Product production, supplemented with a few years leadership experience. You have insight in purification processes and experience with working according to Good Manufacturing Practice. Openness, honesty and focus on continuous improvements and a quality mind-set are natural parts of your personality and the way you work. You have a can-do attitude and focus on opportunities rather than on limitations. Working at Novo Nordisk At Novo Nordisk, we strive for excellence. As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy, we offer our employees opportunities for continuous growth. Contact For further information, please contact Jakob Rune

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