Head of Purification and Chromatography Transfer
Hobson Prior
West Midlands, United Kingdom
2d ago

Main Duties and Responsibilities.

Coordination and management of a multi-disciplinary team whose function is to transfer manufacturing processes from R&D to manufacturing, provide manufacturing support for esoteric materials such as antigens and chromatography reagents

Working with the PMO and planner to schedule the work to coincide with manufacturing cycles

Spearhead the introduction of new processes to meet increasing manufacturing burdens and continue our commitment to continuous improvement

  • Validated methods for processes transferred to manufacturing
  • Column chromatography QC methods and column binding efficiency QC methods developed
  • pFMEA / dFMEA (all aspects of failure mode analysis)
  • Conducting pFMEA on existing production processes and to providing validated improvements for TBS existing products. Ensuring all of the antisera manufacturing validation and methods are fully regulatory complaint and ensuring that product changes are managed to ensure fully reproducible production with the appropriate QC materials is key
  • All work performed must be compliant with standard operating procedures and write ups and data recorded on standard templates
  • Clear experimental design with appropriate statistical rationales. Establish training materials and provide training to all scientific / technical team Right first time approach to QC materials
  • Interactive partnership and communication with manufacturing departments aimed at reducing uncertainty around the QC approach
  • Monitor and communicate progress, and highlight delays or potential risks to projects and timelines to other senior staff.
  • Essential :

  • BSc Hons Degree in relevant discipline
  • 10+ year experience in process protein purification
  • Large team management experience
  • Validation / Verification of manufacturing methods
  • Proven track record in project delivery
  • Polyclonal / monoclonal antibody purification
  • Protein purification
  • pMFEA (severity, occurrence, detection)
  • Desirable :

  • FDA Design Control
  • 510K submission
  • Worked in large industrial polyclonal antibody company
  • Six Sigma / Lean
  • Assay development
  • Immunology
  • Apply
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