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Scientist Drug Substance Development (m/f)

Institution Sandoz GmbH
City Schaftenau
Country Austria
Job Title Scientist Drug Substance Development (m/f)
Description Area of Responsibility
• Provide scientific expert leadership to an Upstream, Downstream or Analytical team (scientists and associates) in the development of processes in support of phase I-III clinical supply through to commercial supply.
• Responsible for the delivery of the technical development projects and ensure fulfillment of all tasks within your area of expertise, in line with the project plans for the development and regulatory filing of biopharmaceuticals.
• Autonomously plan, supervise, evaluate experiments and write reports for development, optimization and scale-up of the processes using statistical design (DOE).
• Ensure timely execution of assigned projects according to agreed project plans, active communication with department and project management, accurate delivery of documents and maintenance of the scientific and technical state of the art of your unit.
• Manage technology transfers to manufacturing sites within Novartis and to external CMO’s.
• Active contribution to CMC teams as USP expert and organize DS sub-team meetings as team lead, respectively
• Advise team members and work according to and author appropriate SOP’s, GxP, HSE, ISEC and Novartis guidelines
Category Development
Keywords Biologics; Development; Drug Substance
Education PhD or equivalent degree in Biological/Biochemical Engineering, Biology or related sciences or equivalent professional experience in an industrial setting.
Experience Experience with mammalian cell lines is essential.
Work experience We are looking for min. 3 years of experience in process development or a related role in an industrial setting.
Experience with technical and operational aspects of large-scale equipment is required; experience in late-stage (Phase III clinical and commercial supply) USP development/characterization/validation, harvest and regulatory filings would be an asset.
Primary Language English
Secondary Language German beneficial
Other Requirements Further requirements include a team player with strong communication, established presentation and scientific/technical writing skills, good management skills with respect to planning, tracking, priority setting and adherence to project timelines.
Reference 190679BR
Comments Please apply online under the following link: www.novartis.com/careers (Job ID 190679BR)

Remarkable developments occur at Sandoz due to the combination of individual characteristics, personal interests and professional qualification. This is why we are seeking employees with a passion for all they do and who will work together with us to achieve the common goal: to provide patients in Austria and all over the world with high quality, affordable pharmaceuticals products. We, Sandoz, are one of the largest pharmaceutical companies in Austria with over 4,000 employees at four sites. As a member of the global Novartis Group, we develop, produce and market generic pharmaceuticals - above all antibiotics, injectable cancer drugs and innovative biosimilars.
Job created Jul 20, 2016 12:30:06
Job last modified Aug 23, 2016 15:21:06