Collins McNicholas

JOB DESCRIPTION 

DSP Manufacturing Technician – Level III

 

OVERVIEW 

A fantastic opportunity for a Biologics Manufacturing Technician with Downstream Processing experience to work for a global biotech based in the Nordics. The ideal candidate will have biologics experience.

 

JOB DESCRIPTION 

 

  • Be able to work in accordance with cGMP and EHS practices, all activities in a compliant and safe manner. Willing to take on additional activities with little or no supervision.
  • The individual will need to perform cGMP activities in Grade CNC, D and C areas.
  • Aseptically purify monoclonal antibodies and protein products by operating column chromatography and filtration
  • Prepare buffers to set specifications in accordance with approved procedures.
  • Proactively ensure the DSP suite and equipment is maintained in a state of inspection readiness at all times.
  • Be an 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.
  • Take ownership of deviations: lead and coordinate investigations as required, to help identify root-cause and appropriate corrective actions.
  • Contribute towards Technology Transfer of processes to manufacturing scale.
  • 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 DSP team.
  • Contribute as required to successful commercial Pre—Approval inspections (PAls), 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 functional 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 protein purification for production of monoclonal antibodies and recombinant protein therapeutic products.
  • Hands-on experience operating downstream processing equipment
  • Experience of protein purification 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 5 years in biopharmaceuticals or technical field is desired.

Proven experience of coaching and mentoring

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