Head of Analytical Development leading Early Phase formulation development support, analytical method development, validation, stability and investigation support for a wide range of oral and inhalation drug dosage forms. Supporting QC activities and GMP Compliance within the Analytical Department.

Study Manager for a team of analysts working on a range of analytical work for a wide range of drug development projects. It includes batch release, method development, method validation and stability.

Oversee all method development, transfer, verification and validation activities and driving process improvement for those activities (including Quality By Design led processes)Oversee process improvement for general laboratory ways of working Oversee process improvement and merger of two stability process flowsOversee equipment purchasing, validation, calibration and maintenance activitiesRelease of QC batch release, stability and raw materials data from laboratoryScheduling of validation, stability and QC activities within laboratory in accordance to fluctuating internal deadlinesOrganisation of equipment decommission and transfer to another laboratoryArrange and oversee external servicing contracts and ensure maintenance of equipment and facilities is fit for purpose.Point of contact for laboratory troubleshooting and testing IssuesAdministration/maintenance role for LIMS and EZChrom CDS systemsManagement of staff across different activities and sites - validation, stability and laboratory technicians to ensure continual personal development and delivery of department objectivesClose collaboration with a number of teams from other QC laboratories, QA, Validation, Regulatory, Sales and Product development teamsMain contact for external customers regarding testing requirements, timelines and results queries, including providing quotes for new and existing work and invoicing.OOS investigations and CAPA implementations lead for the laboratoryWrite, update and review SOP’s and general archiving of all laboratory documentsDirectly involved in MHRA and client auditsCollaboration with Health and Safety to ensure laboratory meets local requirements

Development and Validation of Analytical MethodsValidation, calibration and general maintenance of EquipmentProduction and Review of Protocols and ReportsQA documentation, OOS, CAPA's, SOP's, Deviations

Analysis for Extractables and Leachables and a range of other small molecular compounds.Use and maintenance of Waters LC-UV-MS and Shimadzu GC-MS instrumentation.Use of Headspace GC-MS and GC-FID instrumentation.Processing and reviewing of data using MassLynx and ClassAgent software.Writing and reviewing of protocols and reports.FDA and MHRA audit preparation and involvement.Training of new staff on current extraction methods, instrumentation and processing of data.Liasing with QA, clients and sub-contractors.Raise and process QA documentation.Preparation of COSHH assesments.Qualified first aider.

Analytical lead for stability protocols in late phase inhaled products to GMP requirements. Analytical lead for early phase intranasal and inhaled products, including method assessment, development, validation and stability assessment.Technical lead for LC-MS troubleshooting and investigational activities within the department.Method development and validation for both early and late phase products.Development of associated sample preparation and automation activities.Technical lead for all Chiral method development within the department.Use and maintenance of Agilent HPLC and LC-MS instruments with Empower software.Use of LIMS.Writing of protocols and reports.QA documentation and processes including change controls for relocating instruments, decomission of systems, firmware upgrades and compatibilitytesting during HPLC software transfer.

GMP analytical activities on a range of intranasal products including routine stability work (HPLC, assay and impurities).Device and product characterisation tests on intranasal.Lead analyst for an early phase project including development and validation of all methods, implementation of stability studies.Present results at high level project meetings and collaboration with relevant groups within the company.Method transfer internally within R&D and cross site as part ofproduct transfer to the manufacturing site.

Analysis of inhaled products including various assay and uniformity methods (HPLC), impurity, identity(FTIR) and water content analysis for QC batch release testing.Review of GMP level electronic write ups.Qualified trainer for staff within the laboratory.

Analysis, method development and validation using HPLC, UV, titrations, TLC and dissolution for compliance, quality control, compliant investigation or regulatory purposes for a wide range of pharmaceuticals.