Manufacturing Specialist

Manufacturing Specialist

Biotechnology Life Sciences

Location West Midlands

Salary £26,000 - £35,000

Contract Permanent

Reference HMMaS599

Date Posted

Consultant

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We have an exciting new opening for a Manufacturing Specialist at a leading medical diagnostic company based in Birmingham. The role will support all manufacturing activities including completion of department projects, technology transfer projects, non-conformance, CAPA and general improvement work.

Key Responsibilities and Duties:

  • Develop, improve and scale-up all chromatography column & media strategies
  • Support the transfer of new products into production, ensuring compliance to all safety and manufacturing standards and that all equipment and documentation are available
  • Complete and manage equipment validation projects
  • Complete and manage process validation projects
  • Participate and lead pFMEA or dFMEA assessments
  • Investigate and resolve any CAPA and NCR related actions
  • Resolve and troubleshoot any problems during manufacturing
  • Review manufacturing processes and ensure all processes are within their remit
  • Implement all continuous improvement activities
  • Provide overall support and assist with manufacturing as required

Ideal Skills and Qualifications:

  • Degree-qualified (or equivalent) in a Life Science subject; Masters/PhD would be an advantage
  • Proven laboratory experience in Protein Purification, Protein Chromatography, Chromatography Media & Columns, and AKTA system
  • Experience working in a GMP setting
  • Proven experience taking leadership of pFMEA/dFMEA assessments
  • Experience of CAPA, NCRs, Root Cause Investigation
  • Knowledge of manufacturing and Change Control processes
  • Excellent organisation and time management skills, with ability to work to tight deadlines
  • Desirable: experience working with immunoassays and column scale-up

If you are interested or have any questions about this role, feel free to contact Harriet at CY Partners.

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Manufacturing Specialist

Biotechnology Life Sciences

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