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Head of Purification and Chromatography Transfer

West Midlands, Birmingham

Negotiable

Permanent

Head of Purification and Chromatography Transfer
Location: Birmingham
Salary Offered: Competitive

  • If you are inspired by developing your career in a stimulating environment where you can make a profound difference to the healthcare of patients, my client can offer exceptional careers for exceptional people. Based on an established Bioscience facility in Birmingham, you will have the opportunity to work with smarter science, unique technologies and highly experienced scientific leaders.

  • We are looking for someone that is up for a challenge and who wants to add value to the company by improving our raw material process transfer from R&D to manufacturing and to future proof panel, column and antigen supply.

  • Job Purpose:

  • Over seeing a multi-disciplinary department whose focus is on the sustainable transfer of purification strategies, chromatography materials and protein panels for assay reproducibility purposes to our manufacturing department. The role will require excellent communication skills both, upstream R&D biochemistry departments, downstream manufacturing departments and the PMO.

  • 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.

  • Knowledge and Skills

  • 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)
    dFMEA

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

  • Can you see yourself being part of a company that celebrates diversity and believes that better thinking and decisions come from wider experience? If the answer is yes and you have a desire to be an integral part of a dynamic team, we would be keen to hear from you. In the first instance, please send your CV to Afrin Nupur: ######### . We endeavour to come back to you within 24 hours of CV submission.

Posted 16 days ago

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