R&D Project Manager

• May 2022 - Present

Technical lead on R&D Projects focussed on new product development and existing product or process improvement.

Head Of Quality

• Oct 2021 - May 2022

Head of Quality at BioMonde UK. Ensuring all aspects of quality management, including quality control, quality assurance and quality management systems administration pertaining to the manufacture of pharmaceutical and IVD products was in regulatory, business and commercial compliance. Developing and implementing the Quality department’s strategy, to ensure it meets the businessrequirements and customer deliverables, as well as ensuring the departmental performance againstgoals. Implementing and monitoring all Quality Assurance systems to ensure compliance with EU GMP -- Annex 1 Implementing and maintaining a Quality Risk Management system Acting as the main point of contact on all Quality matters, internally and externally. Coordinating MHRA and ISO inspections and audits. Maintaining MHRA authorisations, including submission of variations (named on licences as responsible for Quality Control). Maintaining and improving departmental operational performance, to meet the requirements ofregulatory authorities, company Standard Operating Procedures (SOPs) and external and internalcustomers, with respect to quality, service, lead time and cost. Ensuring that there is an audit programme in place which is communicated to Operations. Ensuring that the supplier and subcontractor audits are performed and reported as scheduled. Managing all validation activities, including validation strategy and approval of protocols and reports. Maintaining an awareness of new and proposed legislation that impacts the business and communicating any changes to the Senior Management Team (SMT). Ensuring the availability of adequate competent resources to carry out the review and approval batchdocumentation in accordance with in house and GMP requirements.

Project Manager

• Apr 2017 - Oct 2021

• Technical lead on research and development projects. Examples include, but are not limited to:  Producing, characterising and analysing the active ingredients of larval secretions Metagenomic microbiome analysis of L. sericata life stages Development of suitable and appropriate in vitro assays to validate the efficacy of L. sericata and LDT – antimicrobial/antibiofilm, wound modelling, debridement models etc.  Development of a rapid sterility assay utilising 16S Real-Time PCR .  Implementation of Real-Time PCR assay to determine methicillin-resistance in S. aureus isolated from controlled environments through detection of mecA gene. • Improve operations and process efficiency within the business, through the identification of areas for improvement, proposal of operations projects and subsequent management of approved projects. • Ongoing organisational education to build awareness of the R&D function and provide technical understanding of products and concepts.• Ensuring that operations deliverables are completed consistently and on time, and that they meet quality standards, pharmaceutical and medical regulatory, and business requirements

Microbiology Manager

• Jan 2015 - Apr 2017

• Lead Microbiologist for both UK and German production sites. • Batch releasing officer on MHRA license. • Carry out all aspects of product related microbiological testing e.g. sterility, bioburden etc. • Isolate and identify contaminants from any product related or environmental failures. • Ensure compliance with cGMP - Eudralex volume 4, primarily focussed on Annex 1• QMS - ISO90001 & ISO13485 • Environmental monitoring of clean rooms (ISO 14644). • Continually develop and deliver an on going microbial monitoring plan, meeting the needs of production, alongside managing and assigning tasks to relief personnel and production operatives. • Review, revise and author controlled documents; SOP’s, Technical Documents and Work Instructions. • Responsible for calibration of lab equipment and monitoring stock levels of microbiology lab consumables. • Collate and analyse collected data to produce monthly microbiology reports.

PHD Student

• Oct 2021 - Present

PROJECT TITLE: Secretions of the medicinal maggot, Lucilia sericata, and their molecular role in antimicrobial activity and wound healing PROJECT TITLE: Secretions of the medicinal maggot, Lucilia sericata, and their molecular role in antimicrobial activity and wound healing

Postgraduate Researcher

• Oct 2017 - Oct 2019

QC Lab Analyst

• Oct 2014 - Jan 2015

Chemistry:- • Utilise analytical techniques to determine properties of raw materials prior to production to ensure they meet the required specifications. • Use results of raw material analysis to calculate the exact amounts of each raw material required for a specific product specification. • Perform analysis on bases and finished products pre, during and post production to ensure they meet the correct specifications. • Gas Chromatography, auto titration and TOC analyses. • Monitor WFI plant. • Investigate out of specification results, identify and implement corrective actions. Help improve current analytical methods and working practices, alongside validating new procedures. • Maintain laboratory to cGMP and 5S standards. Microbiology:- • Environmental monitoring of ISO Class 5 clean rooms. • Media preparation. • Plate counting and colony identification. • Bioburden and sterility testing. • Endotoxin testing.

Trainee Ecologist

• Jul 2014 - Oct 2014

GO Wales placement, though extended into part-time work. Carried out numerous aspects of ecological survey work alongside principle and consultant ecologists. Such as phase 1 habitat surveys, heterodyne and time expansion bat monitoring, dor mouse surveys, newt bottle trapping and torching. Alongside this I performed species identification analyses using BatSound on time expansion recordings. Furthermore I co-authored phase 1 reports for the consultancies clientele and created vegeation maps for clients using Mapinfo.

Service Fitter

• Sep 2006 - Jun 2014

Examination Invigilator

• Jan 2010 - Jun 2013

Handing out of examination papers. Announcing examination times. Taking registers. Ensuring no malpractice. Helping children with poor reading and literacy skills understand examination questions and structure their answers. Handing out of examination papers. Announcing examination times. Taking registers. Ensuring no malpractice. Helping children with poor reading and literacy skills understand examination questions and structure their answers.