Job Description
Our client, a global healthcare leader with one of the most exciting product pipelines in the industry today now seek a Senior Process Scientist (Cell Culture) for their biopharmaceutical manufacturing centre of excellence GMP facility. This is a permanent role, based in the greater Basel area (Switzerland / France).
This role will help deliver clinical and commercial supply of recombinant therapeutic proteins manufactured through mammalian cell culture at high quality and competitive cost. This position has become available due to a major capacity expansion project, focused on the launch of innovative biomedicines.
The Senior Process Scientist (Cell Culture) will ensure technical oversight of cell culture unit operations which including, supporting the manufacture of biologics bulk drug substance for commercial and late clinical phase products, through process understanding and applied science.
The successful candidate 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.
In addition, this hire 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.
Responsibilities of Senior Process Scientist:
Review cell culture process data to ensure robust and reliable manufacturing performance and quality.
Lead troubleshooting of complex issues during cell culture manufacturing unit operations through process understanding and applied science and engineering.
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 performance, robustness, risks, opportunities.
Present technical analytical data clearly and concisely to customers.
Lead Cell Culture Transfer team, including partners from different manufacturing sites (internal/external) and global functions.
Write (review and approve) CMC sections for regulatory filing documents and responses to questions from Regulatory Agencies. Provide guidance to Site Cell Culture team on appropriate content.
Requirements for Senior Process Scientist:
Degree in biological or chemical engineering or biotechnology, with 5 years professional experience in mammalian cell culture process development in the biopharmaceutical industry.
PhD preferred, 2 years industry experience in analysis of cell culture performance data sets (using cell viability, metabolism, etc, data to understand cell behaviour and resolve processing issues).
Proven in mammalian cell culture experience, in GMP production is a must.
Experience of process validation, resolution of complex (technical, stakeholder) technical issues impacting commercial production or late stage process development.
For details, please contact Larry on +353-1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie / www.meddevicejobs.ie
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