Manufacturing Supervision Technician
11 days ago
León
From mAbxience, a company specialized in the development and manufacture of biosimilar medicines, we are incorporating a Upstream technician for our plant in León. Global Responsibility Responsible for proper execution of cell culture process development and cell clarification activities of antibody and non-antibody protein biosimilar molecules production processes. Provide technical leadership for analysts involved in upstream process development. Contribute for interacting extensively with process development group (UPS and DSP). Specific Responsibilities Responsible for organizing laboratory activities on daily bases, giving support for good execution of the different projects (II, III). Perform laboratory operation at AMBR, 1L, 5L and 50L scale bioreactors, disposable “WAVE” and depth filtration harvest clarification equipment. Execution of upstream activities such as cell banking, seed train, production process (fed-batch and batch), cell line stability studies. Applied DOE & multivariate analysis tools for experimental planning, data analysis (II, III). Data gathering, analyses and creating appropriate statistical presentations, including graphs and charts (I). Data analyses, formulate conclusions and create appropriate statistical presentations, including graphs and charts, and prepare and present written or oral progress reports regarding studies (II, III). 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, Phd is a plus. 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: Knowledge on laboratory operation at AMBR, 1L, 5L and 50L scale bioreactors, disposable “WAVE” and depth filtration harvest clarification equipment. Experienced (I, II) or Expert (III) in upstream activities such as cell banking, seed train, production process (fed-batch and batch), cell line stability studies. Knowledge on mammalian cell line metabolism as well as structure, function of monoclonal antibodies (I, II) with specific understanding of post-translational modifications (III). Travels: Not required. Personal skills: Ability to lead, motivate and train team members and establish priorities and manage competing deadlines for self and others (III). Ability to read and carefully follow instructions. Communication skills to other departments. Excellent problem solving abilities and organization skills (II, III). Leadership skills in staff supervision (II, III). Willingness to work extended and, at times unusual hours to meet business needs. We offer a permanent contract to join a growing pharmaceutical company. Life and accident insurance. Free company canteen. Free online training platform. Free online library. Social, physical and emotional well-being platform. mAbxience is committed to equal opportunities. We do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.
6 Calle Alfonso IX, 24004, León
