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Group Leader – Method Development –Proteins (GMP) AF/016235 South c35-45k
An experienced group leader in method development and characterisation of proteins is urgently required to lead the method development and validation with analytical development. As Group leader in characterisation and method development you will support and lead in all aspects of the process of the characterisation of proteins / antibodies, for the business.
· To provide scientific and technical leadership and expertise in the following assay technologies for purity testing of recombinant proteins: IEX-HPLC, RP-HPLC , HIC-HPLC
· To provide strong leadership to direct reports to enable them to be a highly scientific team by imparting scientific knowledge and experience through mentoring and coaching
· Scheduling and prioritisation of (with input from appropriate management) assays and resources for on time delivery of method development, assay transfers and method validation studies
· Review and approval of study protocols and reports for development, and evaluation studies and ensure that studies are delivered to the appropriate scientific, technical and GMP quality.
· Ensure development of technical and scientific skills for direct reports to maintain quality of laboratory activities and reports delivered to internal and external Customers
· Ensure strong links are maintained with analytical teams in Process Analytics and QC to ensure harmonisation of methods and practices
· Ensure that equipment maintenance and equipment documentation is to the expected quality standards
Qualifications, Skills and Experience
· Substantial and demonstrable experience in the testing, development and validation of
· analytical methods for recombinant protein therapeutics
· Demonstrated experience of implementation of assay technologies for purity testing of recombinant proteins (e.g. IEX-HPLC ; RP-HPLC; HIC-HPLC)
· Proven ability to develop and mentor high quality scientific individuals
· Experience of working for a contract research or manufacturing organisation
· Good general knowledge of pharmaceutical development/ product development
· Commercial experience with GMP or cGMP
If you would like to be considered for this role, please contact Alison Fisher at Hudson Shribman Scientific Recruitment, quoting reference AF /016235, outlining your particular skills and experience and their relevance to this post. Please call on 020 7421 5200, or reply via email, entering the job title and reference code in the subject field to email@example.com
Due to a high volume of applicants only shortlisted candidates will be contacted.