Analytical Scientist – Bioreactor Analytics and Validation

Salary & Details: Competitive salary based on experience. Full Time

Benefits: Share Options; Flexible Holiday policy; On-site gym

Location: Stevenage, but some working from home when appropriate

Report to: Principal Scientist

About MFX

MFX is an award-winning startup developing a break-through bioprocessing platform for the cell and gene therapy (CGT) market, based on microfluidic technology. Its platform allows ultra-low costs and scale-up of CGT from discovery to commercial stages, making these very potent treatments affordable for a wider number of patients, and reducing development times by several years. MicrofluidX is currently developing a system that will allow biologists to test dozens of cell culture conditions in parallel in an automated way replacing the Petri dish, the flask, the bag, the bioreactor, and the centrifuge all at once!

CGTs are fast-growing areas of medical development. With over 700 clinical trials in progress, some treatments (e.g. Kymriah, Yescarta) have already reached the market. This technology is at a critical juncture where advances are achieving clinical realisation, yet manufacturing remains a key challenge, hindering clinical development and patient accessibility. Three critical manufacturing hurdles remain: prohibitive costs of goods, low process stability and control, and lengthy scale-up from discovery to commercial stages.

Position Overview

The Analytical Scientist – Bioreactor Analytics and Validation at MicrofluidX (MFX) will be a key player in advancing the revolutionary bioprocessing platform for the Cell and Gene Therapy (CGT) market. This transformative technology aims to enable ultra-low-cost and scalable CGT production, expediting the journey from discovery to commercialization with unprecedented efficiency. The Analytical Scientist will lead a comprehensive analytical strategy (microscopy, cell viability, cell phenotyping, cell potency assays, gene expression analysis, flow cytometry, and cell metabolite analysis), to analyse the data and present it to the team. In addition to overseeing bioreactor analytics and validation, they will collaborate closely with the product team, providing crucial insights to tailor hardware and bioreactors for process development and cell therapy manufacturing. This dynamic involvement ensures seamless integration between analytical requirements and hardware capabilities, reinforcing MFX’s commitment to cutting-edge solutions for parallel testing of cell culture conditions. Joining MFX presents a unique opportunity to shape the future of bioprocessing technologies, contributing to the vision of making advanced therapies more accessible and cost-effective for a broader patient base while significantly reducing development timelines.

Responsibilities and duties

• Lead and execute a multifaceted analytical strategy process and performance validation
• Utilise a diverse range of analytical techniques to monitor and analyse critical parameters related to bioreactor performance.
• Design and implement validation protocols that specifically address the diverse analytical aspects of bioreactor performance
• Generate, analyse, and interpret data obtained from bioreactor experiments, providing a holistic view of process performance and potential areas for optimisation.
• Maintain and calibrate a variety of analytical instruments, including those required for microscopy, flow cytometry, and gene expression analysis.
• Maintain meticulous records of experimental work, validation protocols, and analytical methods, covering all aspects of bioreactor analytics.
• Prepare clear and concise reports summarising analytical findings and validation results for internal stakeholders and regulatory purposes.
• Collaborate closely with product engineering team to provide crucial process analytics insights to tailor hardware and bioreactor development
• Drive continuous improvement initiatives in analytical methodologies to enhance the precision, accuracy, and efficiency of each analytical component.
• Stay abreast of industry trends and advancements in microscopy, flow cytometry, gene expression analysis, and other relevant analytical techniques.
• Provide training to team members on a broad spectrum of analytical techniques, including microscopy, flow cytometry, and gene expression analysis.

Qualifications and Experience:

• Advanced degree (M.Sc. or Ph.D.) in analytical chemistry, biochemistry, or a related field.
• Demonstrated experience and proficiency in the development and application of a comprehensive suite of analytical methods, including microscopy, flow cytometry, gene expression analysis, and metabolite analysis.
• Experience with Molecular Biology techniques such as PCR, qPCR, immunohistochemistry, flow cytometry, ELISA, etc.
• Familiarity with validation protocols and regulatory requirements for cell therapies i.e. with immunological assays: phenotyping, cytotoxicity, activation, degranulation, depletion, cytokine detection, trans well migration.
• Stay abreast of industry trends and advancements in microscopy (holographic), Raman technologies, LC-MS, and other relevant analytical techniques.
• Strong documentation skills and attention to detail.
• Excellent communication and collaboration abilities.
• Ability to work independently and contribute effectively to cross-functional teams.
• Experience with FlowJo and GraphPad Prism or similar