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(Senior) Process Scientist, USP

Institution Novartis Pharma SA
City Hunigue
Country France
Job Title (Senior) Process Scientist, USP
Description The (Senior) Process Scientist (USP) will support the manufacture of biologics bulk drug substance for commercial and late clinical phase products, through process understanding and applied science. He/She will be responsible for the technical support and optimisation of cell culture manufacturing processes for clinical and commercial products, and the technology transfer (in or out) of process in a GMP environment. He/She will be required to work in close collaboration with the Production Unit, Process Development, Engineering, Validation, Supply Chain, Quality, Regulatory and other departments to ensure quality, on-time supply of our products to our patients.
- Ensure technical oversight of cell culture unit operations. Review cell culture process data to ensure robust and reliable manufacturing performance and quality. Identify areas for improvement in process stability/variability.
- Support/Lead troubleshooting of complex issues during cell culture manufacturing unit operations through process understanding and applied science and engineering. Support/Lead investigation teams, taking into account production environment constraints (e.g., business continuity, planning,).
- Define needs for small/Pilot scale studies supporting late stage development, major manufacturing changes, or as required by regulatory commitments. Define execution planning, resourcing, and budgeting. Write high quality study protocols and reports.
- Write technical documents such as SOPS, investigation reports, campaign summary reports.
- Present technical analytical data clearly and concisely to customers.
- Support/Lead cell culture activities for process site transfers (gap/risk assessments, control strategy adaptation, transfer acceptance criteria). Support/Lead Cell Culture Transfer team, including partners from different manufacturing sites (internal/external) and global functions.
- Identify areas for introduction and development of innovative cell culture processing technologies.
Category Manufacturing
Keywords Biologics; monoclonal antobodies; cell culture; USP; MS&T
Education Degree in biological or chemical engineering or biotechnology (5 years higher education). PhD preferred.
Experience Experience with mammalian cell culture in bioreactors (small or large scale) is a must.
Work experience At least 5 years professional experience in mammalian cell culture process development in the biopharmaceutical industry [large or small scale]. Experience in GMP production highly desirable.
Would consider PhD with 0-2yrs industry experience, if can demonstrate a strong skill set in analysis of cell culture performance data sets (using cell viability, metabolism, etc, data to understand cell behaviour and resolve processing issues).
Primary Language English
Secondary Language French
Other Requirements Experience in one or more of the following areas: analysis of data sets to identify cell culture performance issues/opportunities (e.g., MVDA), raw materials influence on cell culture, -omics, design of experiments
Reference 195268BR
Comments Please apply at www.novartis.com/careers, citing Job Ref 195268BR.

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field.
Diversity of our workforce enhances customer insight and our ability to meet the needs of patients and other stakeholders. Retaining the most qualified talent adds value to our company, our customers, our employees, our shareholders, our suppliers and the communities in which we live and work. We encourage associates to focus on achievement through collaboration and innovation.
Each of us is different. At Novartis, we aspire to move beyond stereotypes, assumptions and bias to bring these differences together every day, so we can see the world through the eyes of our patients and customers, in our quest to make their lives longer and healthier.

At BioProduction Operations Huningue we strive to be the centre of excellence for biopharmaceutical manufacturing and the launch of innovative biomedicines that will improve the lives of our patients.
We produce clinical and commercial supplies of recombinant therapeutic proteins manufactured through mammalian cell culture at high quality and competitive cost.
The Huningue site has just entered a new phase in its growth with the announcement of a 150Meuro major capacity expansion project.
Job created Oct 26, 2016 12:57:12
Job last modified Nov 02, 2016 13:49:55