Job Summary (Primary function)
During the construction and facility startup phase, the Process Scientist Upstream MSAT will be responsible for commissioning and qualification of laboratory upstream and support equipment. These include media preparation, wave rocker for cell expansion, 5L-scale bioreactors system for mammalian cell culture and depth filtration equipment for cell clarification.
Once in operation mode, the Process Scientist will be responsible to support tech transfer and develop qualified downscale models in collaboration with the MSAT downstream Process Scientist. In addition, the function will be responsible for the MSAT laboratory setup and organization, process characterization, process development and supporting production during troubleshooting and investigations.
Essential Functions of the Job (Key responsibilities)
During the construction phase, you will mainly:
Lead the installation of equipment and the organization of the MSAT Upstream laboratory
Lead the definition of User Systems Requirements (URS)
Actively interact with suppliers/vendors of laboratory equipment to ensure technical equipment compliance and delivery dates
Review vendor Qualification package and inclusion within Incyte qualification protocols
Lead SAT, IQ and OQ of MSAT upstream equipment
Lead PQ activities in the area of responsibility
Lead Risk Assessments for MSAT upstream equipment and support risk assessment in other areas (MSAT-DSP and Production)
Support the production team during manufacturing equipment qualifications
Collaborate with and support the MSAT DSP team with the qualification of downstream equipment
Close Interactions with the Process Development team in the USA
Author/review laboratory standard operating procedures or work instructions necessary before the operational phase
Ensure that all MSAT upstream equipment is appropriately qualified and fit for purpose for the development of down-scale models and support to production.
During operational phase, you will mainly:
Author/review laboratory standard operating procedures
Lead MSAT laboratory setup and organization together with the Process Scientist Downstream
Lead/support 5S organization of the MSAT laboratory
Lead upstream downscale model development and qualification
Lead upstream process characterization and Process development
Lead MSAT upstream process risk assessment and support MSAT-USP and/or production process risk assessment
Lead major Investigation in manufacturing related to USP process and define downstream experimental design for root cause identification or confirmation in the context of production investigations
Lead process improvement related to DSP
Act as a mentor to more junior team members and lead by example to ensure timely completion of laboratory objectives and proactively propose problem resolution
Lead writing and review of laboratory protocols and summary reports
Support Tech Transfer of new processes to the Yverdon Manufacturing facility
Contribute to the writing and review of process validation protocols and reports (production and laboratory)
Provide upstream process expertise to the production and MSAT laboratory teams
Maintain required consumable and raw material MSAT laboratory stocks
Media preparation necessary for the laboratory activities
Qualifications (Minimal acceptable level of education, work experience, and competency)
Biotechnology or pharmaceutical MSc degree preferred (e.g. Swiss HES, University, Engineering School) and relevant experience in the biotech industry
Demonstrated practical experience of USP equipment (e.g small scale bioreactors) and processes at laboratory scale with good knowledge of downstream typically 5-10 years
Ability to work in a fast paced highly regulated environment
French and English (Fluent)
Team work oriented mindset
Contribute positively to a strong culture of business integrity and ethics
Act within compliance and legal requirements as well as within company guidelines
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.