Production support specialist (contract)
Since November 2014
Chromatography and Formulation Manager
January 2003 --- January 2013
Manages chromatography and formulation area (incl. lyophilisation). Leads and motivates shift staff including recruitment, performance appraisals and training. Manages new product transfers into manufacturing area from R&D. Investigates discrepancies and closes out corrective actions within area of responsibility. Instigated modernisation of a failing/obsolete process. Drove all stages from capital request & justification, commissioning and training. The project increased both yield (by 30% per cycle) and purity of final product. Moreover, less capital was spent on equipment, giving an estimated capital payback time of 12-18 months. Initiated £500k refurbishment of protein chromatography area to produce a state-of-the-art facility. This increased efficiency/reliability, and decreased product acquired costs by 20%. Scaled-up two processes to improve plant utilisation; one process increased yield by 25% and reduced unit cost, resulting in a new £1m pa contract. Received an ‘Extra Mile’ award for each. Integral part of project team analysing customer base and recommending classification of customers to ensure appropriate service levels delivered to relevant customers. Recommendations were subsequently accepted and implemented by company.
January 2001 --- January 2003
Led shift team in delivery of manufacturing plan. Manufacturing process included fermentation, downstream and chromatograph/final finishing of diagnostic enzyme intermediates. Completed staff performance reviews and delivered training as appropriate. Reported to: Associate Director of Manufacturing. Direct reports: 4 scientists. Created chromatography training programme and delivered it to staff from multiple departments.
August 1995 --- January 2001
Oversaw various chromatography, formulation and freeze drying processes including all in-process analytical testing. Developed SOPs/manufacturing procedures. Led staff training sessions. Reported to: Shift Manager. Co-led project to scale-up process within chromatography/formulation area to respond to increased demand. Scaling-up reduced required runs by 50%. Won third 'Extra Mile' award.
October 1992 --- August 1995
July 1988 --- October 1992
Oversaw tetanus production to cGMP standards.
Biochemistry R&DBiopharmaceuticalsBiotechnologyCAPADiagnosticsGood Laboratory Practice (GLP)GMPGood Manufacturing Practice (GMP)Medical DevicesMicrosoft Officepeople managementPharmaceutical IndustryPowerPointProcess improvementProblem-solving methods and troubleshootingProject ManagementSDS-PAGESOPTeam LeadershipTechnical reports
Skills and Expertise
Create SOPs Develop protocols Lab scale batches Molecular Diagnostics Technology researchAdjust methodsAdjust processes Adjust processes and methodsAdverse event reportingAttend seminarsCalculate process efficiencyCoachCoach staffCollaborate with project teamCollaborate with principal investigatorCreate SOPsCreate standard operating procedure (SOP)Document adverse eventsDocument employees training requirementsEvaluate impurity identificationExecute scientific projectsFinancial administrationFinancial reportsFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesFollow-up of internal auditsFollow-up of external auditsGuide staffImplement Quality Management System (QMS)Identify investigatorsMaintain Quality Management System (QMS)Manage contractors Manage laboratory proceduresManage projects resourcesManage Quality Management System (QMS) documentationManage subject safetyManufacture of GMP batchesmanaging a small teamManufacture of non-GMP and GMP batchesManufacture of non-GMP batchesOral presentationOrganise meetingsOperate research equipmentPilot scale batchesPrepare external auditsPrepare internal auditsProvide trainingReport non-compliance incidentsRespond to audit findingsReview manufacturing documentationSupervise technicians
BSc (Hons) in Biochemistry from NESCOT College in 1996