Senior Scientist, Support Function in QC-CSA
Posted on Jan 15, 2020 by Harvey Nash IT Recruitment Switzerland
For our client in Basel we are searching for Senior Scientist, Support Function in QC-CSA for a 6 months project
Job Title: Senior Scientist, Support Function in QC-CSA
Duration: 6 months (01/02/2020 to 31/07/2020)
Expert in Analytical documentation and processes within the Cell Substrate Analytics team responsible for the molecular characterization and viral safety of Cell Banks used for the manufacturing of Biopharmaceuticals. Coordinates lab activities related to molecular biological test methods for the characterization of production cell lines and derived cell banks and subsequent release testing following cGMP requirements. Coordinates adventitious agents testing of production cell banks and bulk harvests at contract laboratories. Author and reviewer of GMP relevant documents (eg analytical methods, validation protocols/reports, SOPs, specification sheets). Administrative support for review of analytical data and batch records according to SOPs; Harmonization of GMP documentation across projects and processes. Proposes specifications, re-test dates, storage conditions and/or batch release decision according to analytical results and Novartis guidelines.
1. Support specific projects and establish target dates and priorities for lab activities. Prepares lab documentation for Molecular Characterization of Biologics cell banks. Meet quality, quantity and timelines in all projects.
2. Design, plan, perform and monitor all activities assigned. Evaluate data, draw relevant conclusions and write reports for respective molecular characterization and/or viral safety testing.
3. Coordinates adventitious agents testing of production cell banks and bulk harvests at contract laboratories to ensure viral safety of production cell banks.
4. Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s)
5. Contribute to optimization of project related scientific/technical activities and processes within the line function.
6. Provide efficient and robust processes for the testing of production Cell Banks and Bulk Harvest intermediates.
7. Participates to initiatives in the team eg harmonization of GMP documentation.
8. Interact/collaborate with development teams and/or other functions to facilitate transfer of knowledge and deliveries of samples.
9. Generate and select most appropriate scientific documents to hand over to internal and/or external partners (subcontractors, authorities).
10. Work according to appropriate SOP's, GLP, GMP, HSE, ISEC and Novartis guidelines.
11. Report and present scientific/technical results internally.
. MS, PhD or equivalent in Molecular and Cell Biology or related sciences.
. Good knowledge in English and German (oral and written).
. Relevant hands-on experience in a Quality Control or Analytical Development environment is required.
. Knowledge in virology and viral safety is a plus.
. Further requirements include established presentation and scientific/technical writing skills, good documentation management, planning, tracking, priority setting and adherence to project timelines.
For further details please contact Aleksandra Kalicka:
e-mail: (see below)
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