Senior Process Scientist (Cell Culture)
swisselect, leading in life science recruitment in Switzerland
On behalf of our client, a global leader with a mature biologics portfolio, located in Alsace (FR) close to the Swiss border, we are looking for an experienced
Senior Process Scientist (Cell Culture)
The Senior Process Scientist (Cell Culture) 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.
- Define/manage systems for process monitoring. Identify areas for improvement in process stability/variability.
- Identify and drive opportunities for improvements (process capability, yield)
- Lead troubleshooting of complex issues during cell culture manufacturing unit operations through process understanding and applied science and engineering.
- Leadinvestigation teams, taking into account production environment constraints (e.g., business continuity, planning,).
- Ensure appropriate stakeholder engagement and support, and clearly communicate on progress and issues.
- 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 activities for process site transfers (gap/risk assessments, control strategy adaptation, transfer acceptance criteria).
- Lead Cell Culture Transfer team, including partners from different manufacturing sites (internal/external) and global functions.
- Maintain knowledge of regulatory requirements as defined by EMA, FDA, and ICH Guidance Documents. Review technical publications to stay abreast of technical developments in industry. [Proactively share and stimulate knowledge sharing within site and wider drug substance manufacturing and development network.
- 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.
- Identify areas for introduction and development of innovative cell culture processing technologies
- .Lead introduction programme for GMP cell culture manufacturing unit operations.
- Represent MS&T Cell culture team during regulatory and routine compliance audits/inspections.
- Degree in biological or chemical engineering or biotechnology (5 years higher education). PhD preferred
- .Experience in mammalian cell culture at is a must.
- 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.
- Experience of process validation, resolution of complex (technical, stakeholder) technical issues impacting commercial production or late stage process development.
- 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
- Languages: English (fluent), French (good level highly desirable, but not critical). German (good level desirable, but not critical).
If this challenge appeals to you, please do not hesitate to apply, through our online portal or via mail. All applications will be treated in strictest confidence and all applicants will receive a response. For any further questions, please contact Dr. Stefanie Malki (firstname.lastname@example.org).