Collins McNicholas

JOB TITLE

USP Manufacturing Technician Level III

 

OVERVIEW:

An exciting Upstream Processing Manufacturing Technician role has become available working for a global biotech company based in the Nordics.

 

JOB DESCRIPTION 

  • 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

Education:

  • Degree in related discipline or sufficient relevant professional experience.

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.

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