From m Abxience, a company specialized in the development and manufacture of biosimilar medicines, we are incorporating a Upstream analyst for our plant in León. General Responsibility To support the execution of technical activities related to the upstream process development laboratory following the guideline of the process development group. Specific Responsibilities To perform the routine activities schedule weekly in the upstream laboratory: Culturing and seeding of mammalian cell line. Media, feed and buffer preparation. Generating cell banks. Performing and monitoring seed trains and production process at either shake flask, bioreactor or wave system. Metabolites analyses. Washing, sterilization and maintenance of USP equipment. Sterility testing. Data gathering, analyses and creating appropriate statistical presentations, including graphs and charts (II, III). Working with stirrer tank bioreactors and micro-bioreactor. Working according to GLP standards. Maintenance and redaction of Standards Operating Procedures.
Continuous Improvement - will support process improvements throughout the development process. Requirements and personal skills Education: Degree or HNC in relevant Biochemistry/chemistry specialty. Languages: Fluent Spanish, working knowledge in English, knowledge of other languages will be an asset. Experience (years/area): +1 (I), 3-6 (II) or +6 (III) years of relevant expertise in the upstream activities working with biologics pharmaceuticals and biotech environments. Specific Knowledge: Experience in working in biological safety cabinet. Familiar (I) or knowledgeable (II, III) with mammalian cell culture, cellular metabolism as well as structure, function of monoclonal antibodies (biosimilar drugs). Familiar (I, II) or proficient (III) with laboratory operation at AMBR, 1 L, 5 L and 50 L scale bioreactors, disposable "WAVE" and depth filtration harvest clarification equipment. Travels: Not required. Personal skills: Ability to read and careful