Thun, Berne, Switzerland
- Key player in a greenfield facility lifecycle from equipment design to first GMP batches and successful first regulatory authority audit - Protecting the asset by identifying business risks and escalating through senior management to resolution - Scaling systems and people to create and maintain a sustainable high-performing large-scale facility - Maintaining technical depth to ensure oversight on technical process issues and challenges - Creating scalable systems to improve technical growth of employees - Audit tours & presentations for regulatory authority or customer audits
Graduating with a Research Thesis Grade 1.1, and overall Second Class Honours Grade 2.1 Modules: Bioprocess Engineering Biopharmaceutical design & formulation Genetic Engineering Cell & Molecular Biology Microbial Biology Analytical Chemistry Functional Foods for health
- led the successful GMP engineering campaign for a NPI into the downstream wing of a new large-scale mammalian facility - Manufacturing readiness lead for NPI into a large scale mammalian bioprocess facility - Deputy for senior management at governance & departmental management meetings - Applying project management qualification to bring positive change & continuous improvement to the organisation - Interviewing candidates to meet the technical & behavioural expectations of the organisation - Mentoring & scaling of colleagues - Co-led the capex - opex phase transition and successful execution of the first development batch in the downstream wing of the facility
- Technical lead on downstream equipment unit operations - Creation & process mapping of automation recipes for the delta V and MES software engineers - Collaboration with equipment supplier and process engineering to design downstream equipment systems under ASME bioprocess engineering principles - Facility fit analysis for prospective customers - Core downstream member during the capex phase of a CHF 1.5 Billion 6x20Kl mammalian facility - Equipment lead on the start-up and commissioning of downstream unit operations - Supported Capex-phase start up of a new mid-scale microbial facility - Process mapping for automation recipes - Automation recipe configuration on MES / Delta V - Supported SAT & Automation commissioning of USP and DSP recipes - Supported FATs for downstream equipment packages at equipment vendor sites
My final year research project was titled, "A biochemical investigation of T.emersonii and its enzymes in plant biomass conversion". The project was based on the induction and use of thermophilic fungal enzymes on lignocellulosic material to produce bioethanol, from yeast fermentation of the produced monomeric sugar units. The project consisted of laboratory work, thesis write up & a presentation to members of the academic staff. Laboratory skills gained include PCR, gel electrophoresis, enzyme activity assays, autoclaving, fungal incubation, HPLC, & SDS-PAGE. I.T skills used throughout include microsoft word, excel and powerpoint.
- Supported the start-up/CQV phase of a new 1x20Kl microbial CDMO facility - Gave facility & technical presentations at prospective customer tours and departmental meetings - Downstream equipment SME - Guided and supported commissioning knowledge capture for the Opex team - Travelled to collaborative business partners facility in the UK to analyse their manufacturing process as part of tech transfer - Review and approval of commissioning lifecycle documentation
- Supported operations manager to drive on-time delivery of GMP drug substance batches - Deputy people manager of operators - Process/Equipment SME for vaccines bioconjugation - Troubleshooting process issues on the manufacturing floor - Cross-functional collaboration on technical issues - Ownership and execution of manufacturing deviations - Presenter in Audit situations - Led major deviations - Led safety investigations to completion & CAPA control measures
- MSc student placement in QC with cross-functional engagement - GMP/GDP experience across API & Large Molecule - Deviation / CAPA / Change management ownership & execution - Chemistry lab testing on a range of lab equipment - Lab systems experience - Strict ALCOA+ work environment - MSc thesis written & conducted on Schizophrenia API’s and quality testing methods