Pharma
Process Technician/ Analyst
Functieomschrijving
The Lab Analyst II is a member of the Analytical Science and Technology (AST) team in the Recombinant Mammalian Drug Substance (DS) function within the global Manufacturing Science, Analytics and Technology (MSAT) organization and is based in Sanofi Geel biopharmaceutical manufacturing site. The Recombinant Mammalian DS platform function within global MSAT is the owner of Life Cycle Management of mammalian cell culture-based DS Processes within Sanofi biologics manufacturing network. We deliver innovative, robust, and cost-effective next generation processes, enable launch of new products, and provide commercial manufacturing/Quality Control support.
The function is responsible for planning and performing routine assays to support assay transfer activities, small-scale studies, manufacturing and R&D processes, investigations and launch of new products. Our expansive portfolio covers multiple products, modalities, and expression systems within 12 internal and external global sites in US and EU. We will be supporting launch of 20+ new products in next 3-5 years including monoclonal and multi-specific antibodies, fusion proteins, antibody-drug conjugates, synthorins and nanobodies. We are pursuing future innovations such as digital labs, factory of future and advanced analytics-based process understanding and control.
Main responsibilities:
- Take ownership of own planning of analytical HPLC assays to ensure deadlines are met.
- Follow experimental procedures and guidelines for routine assay execution. Having insight in the way of working of the assay.
- Clear, correct and scientific reporting, documentation and communication of assay results or overview of results via protocols and reports.
- Critical reviewing of analytical HPLC assays
- Act as expert for analytical HPLC including troubleshooting.
- Support analytical activities for product characterization, transfer and process improvements for products in late development, next-generation, or commercial phase.
Profiel
Experience:
- You have a Bachelor in Life Sciences, additional practical experience in industry or academia is preferred.
- You have a good understanding of chromatography methods and can rely on this knowledge to accelerate projects and support troubleshooting. Prior hands-on experience with liquid chromatography and troubleshooting is highly desired.
- Experience with large molecule work is a plus.
- You have an understanding of GMP and the manufacturing and testing of biologics.
Skills:
- You are willing to work in the laboratory, which means being on-site. Laboratory work >75% is expected for this position.
- You work with a high degree of autonomy and independence.
- You have a strong sense of ownership and responsibility with a quality-oriented and right-first-time mindset.
- You are able to multi-task and handle different priority tasks at the same time, which means you are highly stress resistant.
- You are flexible both in terms of planning and working hours, willing to adapt to changing priorities and willing to learn at a rapid pace. In addition to routine testing, you are willing to support small scale studies, quality investigations and MSAT driven projects if requested.
- You have an analytical problem-solving mindset, you work and document accurately and have an eye for detail.
- Good technical writing skills for protocol, memo and report writing related to analytical procedures and processes is a plus.
- You are a strong communicator, who can connect, discuss, and find compromises with people in other teams, colleagues and group leads.
- You like to work in a team and consider yourself a good team player. This includes contributing to the quality and safety minded way of working.
Languages: Dutch + English
Aanbod
Why Sanofi?
- Sanofi immediately offers a fixed contract and a full-time position
- Growing organization where commitment, integrity, entrepreneurship and cooperation are driving values
- Working in a high-tech environment
- Dynamic sector with growth opportunities
Bedrijfsinfo
Sanofi is een gediversifieerd bedrijf in de gezondheidszorg en is één van de grootste farmaceutische ondernemingen ter wereld. Samen met onze partners zetten wij ons actief in om de gezondheid te beschermen, de levenskwaliteit te verbeteren en antwoorden te geven op de behoeften en noden van 7 miljard wereldburgers. De missie van Sanofi ’to chase the miracles of science to improve people’s lifes’ vereist dat we een sterke leercultuur opbouwen. Door diverse leermogelijkheden te bieden en je in contact te brengen met nieuwe leergebieden die je passie ondersteunen, maken we het voor jou mogelijk om een verschil te maken.