Descripción de la oferta
From Mabxience, a company specialized in the development and manufacture of biosimilar medicines, we are incorporating a temporary MSAT technician for our plant in León.
Global Responsabilities
Organize the implementation of manufacturing processes in any of the producing lines at mAbxience (León); identification and proposal of continuous improvement programs in production; scientific support on deviation and non-conformity solving as well as assessment and implementation of new technologies in producing lines.
Specific responsabilities
Follow and participate in process developments by R&D in order to ensure that their execution at industrial scale will be possible as for infrastructures, materials, operations and costs, exposing all with a process risk assessment in regards of facilities and scale applicable to these.
Technology transfers performed in between company units or with external customers, in order to ensure that their execution at industrial scale will be possible as for infrastructures, materials, operations and costs.
Write and verify documentation needed to start up manufacturing process in producing lines. For instance:
Process descriptions.
List of materials and Raw Materials and their specifications.
Manufacturing Versions and roadmaps.
Initial Master Batch Records.
Scale-up rationale and report.
Additional scale-up protocols/reports such as stability studies of intermediate products among others.
Coordinate and provide training courses on new operations to the different production sections.
Coordinate and provide scientific support to production throughout execution of engineering batches and early GMP batches, following up process trending as well as analytical product parameters: data gathering.
Coordinate and support to R&D for studies included in Process validation stages, including DSM, viral clearance, and resin lifetime studies, as well as process characterisation.
Follow up of process or product deviations, identifying possible root causes, potential impacts, proposing corrective and preventive actions, as indicated in the corresponding quality procedure.
Coordinate with other departments sampling plans for first batches manufactured in GMP facility for new process under implementation.
Identification and evaluation of process improvement and optimization opportunities. Asses their impact and coordinate their implementation with the different involved departments (Engineering, R&D, Quality, Supply Chain, Purchases…).
Suggest and assess implementation of new technologies, equipment, or different usages of these, functioning as Operations interface with the departments of Engineering, R&D, Quality, Supply Chain, Purchases…
Support and organization of the writing, execution, and reporting, as it may correspond, for the different experiments and studies associated to batch implementation, researching on any incidence or proposal of process improvement.
Qualifications
Education: University degree oriented to biology or chemistry
Languages: Intermediate English level (fluency valued)
Experience (years/area): ≥2 years in Operations, R&D, MSAT
Specific Knowledge: Work in GMP environment, UPS-DSP experience, Tech transfer, process validation.
Personal skills : Result oriented, attention to detail, Teamwork oriented
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.
