LifeArc

Principal Scientist

LumiraDx

Owning the launch of diagnostic products on the LumiraDx Point of Care (POC) platform in fast-paced environment in response to the COVID-19 pandemic.

•	Driving both lab-based development & compiling regulatory paperwork, such as development reports and technical files for submission,  
•	 Development of additional 5-minute rapid tests to add to the platform test portfolio.
•	Solving technical challenges, communicating outcomes to senior management.

Achievements

•	Leading the development and validation of COVID/RSV POC test, to achieve CE-marking before an external CE-marking deadline of May 2022. Due to several internal projects aiming to meet this deadline competing for limited resource, this involved careful planning and negotiation for internal resources to ensure on-time project completion.
•	Contributing to the CE-and EUA submissions for COVID/FLU & rapid COVID POC testing.

Technical Manager Assay Development

Biotangents Ltd

As the lead scientist within an innovative start-up Biotechnology firm in the field of animal diagnostics, my responsibilities include: 
 
•	Leading a high performing team of technical specialists and of all associated aspects of lab operations including optimising use of resources. 
•	Leadership of the design and oversight of an innovative diagnostic device for the diagnosis of veterinary pathogens for use by farmers or vets. 
•	Planning and designing a work programme to enable technical validation by external parties and scale-up to commercialisation, including risk analysis/mitigation of the process. 
•	Board and stakeholder communications, including translating complex technical data and procedures for a non-technical audience into reports and presentations. 
•	Providing expert direction for the introduction of a company Quality Management System (QMS). 
•	Performing the duties of health and safety office to ensuring safe working practices. 

Achievements
•	Leading the rapid adaptation of the technology for detection of COVID-19 during the global 2020 pandemic. 
•	Aiding company growth from 5 to 13 employees, including hiring & onboarding of new staff, and managing the budget of purchase of new equipment during a move to larger premises. 
•	Overseeing the first phase of implementation of ISO9001 regulatory standards including a Quality Management System (QMS). 
•	Contribution to multiple submissions for patents for the company’s proprietary technology.

Senior Scientist

Quotient Limited

Managing the development of innovative technology for detection of viruses in human blood, to scale for use in large healthcare environments on an automated diagnostic platform. Within this large multi-national biotechnology firm, my responsibilities included: 
 
•	Leadership of a team comprising of six individuals (graduate to senior-scientist level) In addition to having oversight of a remote team in Switzerland to organise scale-up and commercialisation of the technology under design control and a GMP environment. 
•	Directing and guiding international third-party collaborators (based in USA, Netherlands). 
•	Leading integration of programme and technology within wider product development environment, ensuring alignment of key milestones and resource management. 
•	Deep understanding of regulatory requirements and ensuring product & process conformance with international standards. 
•	Developing effective data analytics processes to identify trends and statistically significant results to make informed data-driven decisions. 
•	Attendance at international events and tradeshows, communicating technical results to key stakeholders. 

Achievements

•	Leading the successful technology transfer and validation of processes to the Good Manufacturing Practice (GMP) assured site in Switzerland, for commercial production. 
•	Identifying & leading the Commissioning of high-quality research and development activities from global collaborators (USA, The Netherlands), resulting in company intellectual property and commercial technology. 
•	Laying the foundations for rapid development and response to new diseases, such as coronavirus.

Disease Screening Manager

BioReliance

In this multinational contract research organisation, I led biological safety testing for a wide variety of commercial customers (such as pharmaceutical companies and manufacturers). My responsibilities included: 
 
 
•	Scientific leadership ensuring projects were carried out with appropriate scientific oversight and ensuring GMP compliance, to tight deadlines. 
•	Leading departmental assay development/ validation and process-improvement projects. 
•	Building and strengthening relationships with a range of international clients on routine & custom projects, solving complex problems & completing such projects to agreed timescales. 
•	Leading and effectively closed investigations into company non-conformances, implementing effective corrective actions via change control when required. 
•	Management and prioritisation of resources across multiple projects at once to ensure timelines were met efficiently. 
•	Collaboration with other departments, both technical and non-technical, to ensure that expectations of goals, objectives and timelines were aligned. 
 
Achievements include: 
 
•	Significantly contributed to the training and mentoring other personnel in the theoretical and practical aspects of molecular biology. 
•	Leading a process-improvement project to reorganise the department’s work structure, in consultation with other departments, to enable the department to work more efficiently. This resulted in reduced costs and turnaround times. 
•	Organised the department’s workload in response to client-demand due to the 2014 Ebola outbreak, to ensure that multiple clients’ potential vaccines were tested quickly to allow clinical trials to start on time.

In this position I am directly responsible for the planning, direction and co-ordination of studies, and for compiling, analysing and evaluating data from such studies to both GLP and GMP levels of compliance in the Molecular Biology Department. I am involved in the writing of protocols, Standard Operating Procedures, reports and other documentation, as well as validation of new assays and scientific equipment. Scientifically, the work involves several aspects of Molecular Biology, including nucleid acid extraction, conventional and real time PCR.

 I also interact with clients as required to answer specific technical queries, as well as being responsible for the completion of projects and commercial work within their areas of control, meeting agreed standards and time-scales. As well as and coaching other personnel in the theoretical aspects of work appropriate to their area(s) of responsibility and expertise.

Scientist

The University of Edinburgh

Responsible for designing and implementing a high-throughput screen of the human genome to identify genes responsible for viral infection and replication. This project is performed in collaboration; and therefore enabled me to work as part of an inter-continental research team.

Organising separate disciplines within scGTI to ensure that this project is performed efficiently. This includes personally handling the molecular biology of the project, as well as coordinating with the robotics and bioinformatics units so it can be performed on a large scale and the vast amount of data generated can be efficiently analysed.

Other small scale projects such as analysis of miRNA processing during mouse cytomegalovirus (MCMV) infection and genome-wide gene transcription profiling following siRNA knockdown of key immune response genes. These projects have used many techniques including RNA extraction, qRT-PCR and microarrays, in areas including virology, immunology and cell biology.

Post Doctoral Scientist

ExpressOn BioSystems Ltd

Responsible for project managing the identification, research and development of new products in the emerging microRNA (miRNA) field. This involved; (1) reviewing this field and identifying unmet needs of the research community and therefore potential commercial products; (2) designing and constructing products to suit these needs, and (3) product validation and commercialisation, involving production of scientific data and critical analysis of this data.

Producing informative yet concise scientific reports summarising scientific data and achievements.

Developed an expert understanding of scientific procedures including cell culture, RNAi, cloning and QPCR.

Project development manager

Responsible for the technical development of Expresson's key technology, ACCESSarray, from initial product development through to commercialisation. This included extensive product testing and validation, stability testing and the establishment of key standard operating procedures (SOPs) for the use of the product.

Managing the development of proprietary software for ExpressOn for the interpretation of ACCESSarray. This involved liaising closely with out-of-house software developers to establish the function of the software as well as extensive program and bug testing.

Working on standard and bespoke client projects, liaising with the client on a regular basis.

Promotion of the ACCESSarray product, at an academic and commercial level, presenting scientific talks and attending trade shows respectively.

Contributing to the continuing development of the company in weekly scientific meetings.

Senior research scientist

I am a highly-motivated Ph.D. scientist specialising in driving immunological and molecular-based diagnostic assays to meet business requirements. As someone who thrives working in fast-paced commercial GMP environments, I am experienced in all aspects of the product lifecycle from initial feasibility to validation, including design control and FMEA-based risk analysis. I relish opportunities to proactively problem-solve and implement process improvement strategies, while a focusing on customer requirements by considering the wider commercial implications of decisions made.

Key skills include:
Project management: ensuring work is planned, resourced and executed to meet timelines. 
GMP: working within a Quality Management System (QMS) to ensure all work is fully compliant with regulatory standards.
Process Improvement: engaging with stakeholders to manage organisational change to improve operational efficiency.
Team management: inspiring and directing teams to achieve goals in specified timelines.
Multi-tasking: successfully being able to manage several projects in parallel and prioritise time and resource accordingly.

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