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Senior Biotechnologist (USP)

Mantell Associates
Leeds
9 months ago
Applications closed

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Mantell Associates is partnered with a full integrated speciality biopharmaceutical company, who are seeking a Senior Biotechnologist focused on Upstream Manufacturing (Drug Substance Manufacturing).


Senior Biotechnologist - Responsibilities:

  • Work in accordance with cGMP and EHS practices, conducting all activities in a compliant and safe manner. Willing to take on additional activities with little or no supervision
  • 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 bioreactors in 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 always maintained in a state of Inspection readiness
  • 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
  • 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 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 functional area of responsibilities


Senior Biotechnologist - Responsibilities:

  • Degree in related discipline or sufficient relevant experience
  • Knowledge/experience of mammalian cell culture for production of monoclonal antibodies and recombinant protein therapeutic products
  • Hands-on experience operating upstream processing equipment
  • Experience of cell culture principles, techniques, scale up, technology transfer and process validation activities
  • A minimum of 5 years in biopharmaceuticals or technical field, desired
  • Proven experience of coaching and mentoring others
  • Experience of supporting Pre-Approval Inspections (PAI) and working with international regulatory agencies including the FDA and EMA
  • Expertise of cGMP compliance and associated documentation


Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.

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