Responsible for laboratories - analytical chemistry, scale up, formulation and biologyDevelop scale up laboratory and transfer in pilot plant into Oxford lab from CDMO Increased yield of clinical product by 90%, simplified design and reduced production time.

Responsible for R&D laboratories - analytical chemistry, formulation and biology. Manages a team of scientists, and works with stakeholders to set timelines/budgets. Involved with CMC and regulatory filings.Built three laboratories and works with Quality to establish policies, SOPs and processesDeveloped LC-MS methods for bioanalysis of ocular tissues (DMPK) and characterized extractables from primary packaging and proprietary medical devices.

Responsible for all chromatographic data within Consumer Health GMS, supporting 21 sites. Overseen global upgrade to Empower FR4 and managed the integration of Pfizer CH sites into GSK Provided training and support to manufacturing sites, managed incidents and worked with stakeholders to maintain compliance within a GMP environment

Responsible for Extractables and Leachables (E&L) programme to support product pack lifecycle.Subject matter expert for E&L, global manufacturing & supply - pharmaceuticals and consumer health products - medical devices and primary packaging.Provided support to all GMS sites and GSK aligned CMOs; supported regulatory filings and responded to regulatory agency questions (FDA & EMA). Managed teams of scientists and worked with stakeholders and customers to set timelines/budgets.

Analytical Science and Technology European Central LaboratoryResponsible for projects across categories including:Extractables and LeachablesProject management (CROs)Method Development and Validation of analytical methodsAnalytical Remediation, Method Development and ValidationWorks with Process Robustness Teams to correct systemic analytical methods Develops methods to simplify and unify assays across formulation families (product class monographs) using modern methodologyProvides Mass Spectrometry expertise for team (LC-MS, GC-MS)

Chemistry Laboratory ManagerResponsible for projects and budgets. Overseen the setup of Chemistry laboratory, managed the creation of documents and validation of instruments, equipment and methods.Authors and contributes to documentation. Performs audits of vendors and contractors. Reviews 3rd party stability and OOS reports. Analytical ChemistArea of expertise: Formulations (topical and oral dosage forms), analytical and bio-analytical.Provide analytical support to R&D projects and assets.Responsible for the method development and validation of analytical methods.Develops and executes DMPK studies.Provides oversight and technical assistance of QC/QA activities of the contract manufacturing and laboratory organisations.

Supervisor of analytical laboratory; deputy for Laboratory Team ManagerManages day to day activities of large laboratory, involved in appraisals and interviews of staff and provides training and guidance on technical issues.Authors, reviews and contributes to documentation. Leads Laboratory Investigations and implements CAPA. Uses tools such as GEMBA, 5Whys and Fishbone analysis to find root cause and prevent further reoccurrence.Liaising with NPI, Planning, and Warehouse teams to meet operational objectives.

• Lead QC Chemist for Development of new radiopharmaceuticals (small molecules, proteins and peptides)• Responsible for the method development and validation of analytical methods for the HPLC, IC and LC-MS (ToF and Ion Trap)• Responsible for the quality control analysis of Sterile Radiopharmaceuticals for clinical and research use (HPLC, LC-MS, GC, IC, NMR and endotoxin)• Authors, reviews and contributes to SOPs, change controls, CAPAs and OOS reports• Supervisor of the Microbiology Department• Implemented the Environmental Monitoring and Control program over GMP areas• Trends analytical and microbiology data, creates reports and auditing areas for compliance• Provides Training on Analytical Techniques and characterization of research compounds• Created laboratory efficiency program saving £40k per annum• Performed extractable and leachable studies to support clinical products

Responsible for the quality control analysis of Sterile Radiopharmaceuticals for clinical and research use (HPLC, GC, IC, endotoxin and wet chemistry techniques)Responsible for the Blood and Metabolite analysis of clinical samples (HPLC, blood gas analyser and wet chemistry techniques)Validated analytical methods and instrumentsSupervised Raw Materials analysis and responsible for release of materials for GMP useAssisted with Environmental Monitoring and Control of GMP areasMember of the Chemical Management Team

Performed the analysis of in-process and finished products using a variety of techniques: HPLC. GC, IC, FT-IR, AAS and classical wet chemistry.Assisted in instrument and method validations

Supervised QC laboratory expansion and reorganization; construction of gas closet, installation of fume cupboard, AAS, FT-IR, HPLC and UV/Vis spectrometerResponsible for instrument validations and method transfersPerformed analysis of oral care pharmaceuticals on finished, in-process and stability samples

Perform the analysis of in-process and finished products using a variety of techniques: HPLC. GC, AAS and classical wet chemistry Assisted with instrument calibrations and method validations.

Performed the analysis of corn, wheat and soybean seeds to support research teams using a variety of techniques: HPLC. GC, IC, protein analyzer, accelerated solvent extractor and classical wet chemistry.