USP Manufacturing Technician Level III
An exciting Upstream Processing Manufacturing Technician role has become available working for a global biotech company based in the Nordics.
- Be able to work in accordance with cGMP and EHS practices, conducting all activities in a compliant and safe manner. Willing to take on additional activities with only moderate supervision.
- The individual will need to perform cGMP activities in Grade CNC, D and C areas.
- Culture mammalian cells aseptically from cell revival stage in shake flask until end of production process in Single use bioreactorsin accordance with the relevant protocols.
- Prepare media and buffers to set specifications in accordance with written protocols.
- Proactively ensure the USP suite and equipment is maintained in a state of Inspection readiness at all times.
- Be a SME author/reviewer and/or approver for written procedures, SOPs, BMRs and other cGMP documentations in span of expertise.
- Assist in execution of technical and validation protocols.
- Contribute to investigations as required, to help identify root cause and appropriate corrective actions.
- Supervise and ensure laboratory work is carried out according to cGMP.
- Coach and mentor new starters to contribute to achieving a multi-skilled and engaged USP team.
- Contribute as required to successful commercial Pre-Approval Inspections (PAIs), regular Audits and any other interactions with regulatory agencies.
- Actively involved in tasks that involve other departments in the company, in addition to other tasks assigned to him/her.
- Continually identify process improvement to help create and maintain a lean, flexible and agile manufacturing facility.
- Demonstrate operational excellence within funtional area of responsibilities.
- Adhere to the company etiquette in all matters of behaviour and manners
EDUCATION AND EXPERIENCE
- Degree in related discipline or sufficient relevant professional experience.
- Knowledge/experience of mammalian cell culture for production of monoclonal antibodies and recombinant protein therapeutic products.
- Hands-on experience operating upstream processing equipment.
- Knowledge/experience of cell culture principles, techniques, scale up, technology transfer and process validation activities.
- Knowledge/experience of supporting Pre-Approval Inspections (PAI) and working with international regulatory agencies including the FDA and EMA.
- Knowledge of cGMP compliance and associated documentation.
- Minimum of 3 years in biopharmaceuticals or technical field, desired.
- Proven experience of collaborative team-working, leading when appropriate.