United Kingdom
I am a highly motivated and detail-oriented MSAT professional with a First-Class Honours degree in Biochemistry from the University of Leeds. My experience spans microbiology, analytical development, quality control, and process support within the pharmaceutical and biotechnology industries. I specialize in supporting GMP manufacturing and product lifecycle activities, ensuring robust, compliant, and efficient processes through both technical expertise and cross-functional collaboration. Key Skills and Achievements: MSAT Experience: -Product Lifecycle & GMP Support: Delivered NPI and PPQ support for BDS introductions and provided on-shift technical guidance to ensure successful process qualification and GMP compliance. -Process Verification & Risk Management: Executed Ongoing Process Verification (OPV) activities, designed cleaning verification protocols and updated Single Use System FMEAs. -Cross-Functional Leadership & Investigations: Led deviation clinics, coordinated external analytical testing, interpreted process data from laboratory investigations, and written product quality risk assessments to resolve critical batch release challenges. Microbiology Expertise: - Proficient in bioburden testing, raw material testing (MLT), and sterility assurance using GMP aseptic techniques. - Developed standard work instructions (SWIs) and training videos to enhance compliance and reduce human error. - Contributed to regulatory audits (MHRA, MFDS) by updating documents and maintaining alignment with pharmacopoeia standards. Analytical Development: - Validated and transferred analytical methods for monoclonal antibodies and enzyme production as part of process development. - Skilled in liquid chromatography (UPLC/HPLC), mass spectrometry, and capillary electrophoresis for advanced characterization. - Championed high-throughput techniques, attending training and promoting adoption of innovative technologies. Leadership and Collaboration: - Served as a cross-functional team member during critical deviations, regulatory audits, and process improvements. - Trained operators and senior analysts in advanced techniques, fostering skill development and resource optimisation. - Acted as a project lead, liaising across departments to ensure timely and accurate results. I am adept at applying critical thinking to solve complex problems, ensuring compliance, and driving innovation. My commitment to continuous development is evident through my diverse NPI support, laboratory techniques, regulatory expertise, and leadership roles.
Supported Product Lifecycle Management activities. Provided on-shift technical support during NPI PPQ activities. Conducted Ongoing Process Verification (OPV) activities by analysing comprehensive monthly PPA data trends and updates to Process Dataset Definition (PDD). Designed and executed cleaning verification strategies. Delivered data driven problem-solving investigations for critical batch release challenges, by leading initial DE clinics, coordinating sampling/shipping, interpreting analytical data, and writing product quality risk assessments. Updated and maintained Single Use System FMEAs. Performed technical assessments to support investigations.
Performed bioburden testing of sterile finished products/bulks/intermediates from four facilities within 24 hours of their manufacture, using GMP aseptic technique to ensure patient safety. Tested Raw Materials for both Sterile and I&D products, using MLT and subculturing. Verified non-sterile environmental monitoring in SAP to support the validity of GMP within production. Assisted a deviation as SME throughout 30 day clinic progress - supplying the “background information”. Aided ALEs through writing initial impact assessments/lab investigations to ensure a quality process. Fundamental member of a cross-functional rapid response team to a critical deviation for a Sterile PQ product. Created a SWI for a modified MLT test to aid the detection of water-borne Gram-negative organisms. Supported 2–4 day audits from the MHRA, MFDS, Dermavant, Viiv and Haleon – updating documents according to findings and regulatory changes in pharmacopoeia. Successfully trained an operator in bioburden testing, to increase resource following analysis. Investigated media used in bioburden testing to assist a Lean Six Sigma green belt project. Created two training videos for filtration and cleaning, to reduce human factor and standardise practices. Software: SAP, LIFT, Veeva Vault Quality (VQD), Power BI, Excel.
Undertaking an undergraduate final year research project in Fc gamma receptors, involving Affimer technology. Laboratory techniques: Transformation, Agar Plates, Inoculation, Plasmid mini-prep extraction, Digestion, Agarose Gel Electrophoresis, Gel DNA extraction, Ligation, Preparation for Sanger Sequencing, Polyacrylamide Gel Electrophoresis, Auto-induction, Induction
Enhanced analytical methods for 9 projects within process development, to result in the manufacture of mAbs and enzymes as the API of pharmaceutical therapeutics. Validated an established Analytical Method, before technology transfer into routine manufacturing. Trained senior analysts in N-glycan analysis (GlycoWorks Kit) and trainee analysts in UPLC analysis within the Empower Chromatography Data System. Exclusively deputized the lead role of a project, whilst performing the laboratory analysis, working cross-functionally between upstream/downstream departments within the Billingham and Wilton site, UK. Promoted High Throughput (HTP) techniques to the AD department and attending additional training for Andrew+ as a representative of the HTP process development team – to invest in future technology. Co-ordinated sample deliveries, following the EHS/COSHH guidelines, for distribution to the Wilton site, UK and North Carolina, USA. Laboratory Experience: - Techniques: Liquid Chromatography (UPLC/HPLC) - SEC, Reverse Phase, ProA, N-Glycan Analysis; SDS-PAGE; Maurice - Capillary Electrophoresis, Capillary isoelectric focusing; Solo VPE and Nanodrop - Mass Spectrometry: Waters BioAccord LC-MS System using UNIFI Scientific Information System for analysis - Glycan Analysis, Intact Mass and Peptide mapping - High throughput systems: Tecan Freedom EVO (T100, T200) and Waters Andrew Alliance (OneLab)