Engineering Project Manager

Engineering Project Manager

Engineering Project Manager

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

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

Location: Stevenage

Report to: VP of Product Development

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

It is an exciting time at MFX Bio as we develop a revolutionary system for the cell and gene therapy market. We are looking to recruit an Engineering Project Manager to help us develop this transformative technology. This role involves project managing projects to successfully deliver both our consumable products to market and could also involve the project management of the delivery of hardware projects to production.

Our platform will enable ultra-low-cost and scalable CGT production, expediting the journey from discovery to commercialization with unprecedented efficiency. 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.

The Engineering Project Manager role will be project managing pre-production consumables and hardware and with the role transitioning to the managing products introduction into the Cell and Gene therapy marketplace.

Responsibilities and duties

  • Project Planning: Develop comprehensive project plans that outlines the scope, objectives, timeline, budget, and resources required for the project being managed.
  • Resource Management: Allocate resources effectively, including personnel, equipment, and materials, to ensure the project stays on schedule and within budget.
  • Contract and Supply Chain Management: Participate in supplier selection and manage the set up of contracts with vendors, subcontractors, and other third parties involved in the project. This includes negotiating terms, ensuring compliance, and resolving any disputes that may arise. Alongside this activity working with purchasing to set up blank orders with suppliers.
  • Risk Management: Identify potential risks and develop strategies to mitigate them. This includes creating contingency plans for unexpected events that could impact the project.
  • Stakeholder Communication: Maintain regular communication with stakeholders, including suppliers, team members, and senior management, to keep them informed of project progress and address any concerns.
  • Quality Assurance: Ensure that the project meets all quality standards and specifications. This may involve conducting regular inspections and tests to identify and address any issues.
  • Budget Management: Monitor project expenses and ensure that the project stays within the allocated budget. This may involve negotiating with vendors and suppliers to secure the best prices for materials and services.
  • Schedule Management: Develop and maintain a project schedule that outlines key milestones and deadlines. This includes tracking progress and making adjustments as needed to ensure that the project stays on track.
  • Team Leadership: Provide leadership and guidance to the project team, including assigning tasks, setting goals, and providing feedback. This may also involve resolving conflicts and
    motivating team members to perform at their best.
  • Documentation: Maintain accurate and up-to-date project documentation, including plans, schedules, budgets, and reports. This ensures that all project information is readily available and accessible to stakeholders.
  • Health and Safety: Ensure that all work is carried out in a safe manner and that all relevant health and safety regulations are followed. This includes conducting regular safety inspections and providing appropriate training to team members.
  • Change Management: Manage changes to the project scope, schedule, or budget that may arise during the course of the project. This includes evaluating the impact of the change, obtaining approval from stakeholders, and implementing the change in a timely manner.

Qualifications and Experience:

  • 3+ years of demonstratable project management experience.
  • The candidate must have strong project management and leadership skills, including the ability to develop and manage project plans, allocate resources effectively, and monitor progress against milestones and deadlines.
  • Strong technical skills are essential for this role and experience of managing projects in the life science or medical industry is required. This includes a deep understanding of engineering principles and practices. Familiarity with relevant software and tools, such as project management software is also required.
  • A bachelor’s degree in engineering or a related field is required.
  • Project Management Professional certification from a recognised Project Management Institute or an equivalent certification would be beneficial.
  • Excellent communication skills are essential for this role, including the ability to communicate effectively with team members, stakeholders, suppliers and partners. This includes both written and verbal communication skills.
  • The role requires someone with good problem-solving skills, including the ability to identify potential issues and develop effective solutions.
  • Strong organizational skills are essential for this role, including the ability to manage multiple tasks and priorities simultaneously.
  • It is beneficial for the candidate to have a strong attention to detail, including the ability to identify potential issues and ensure that all project requirements are met.
  • This role requires someone who can work effectively as part of a team, including the ability to collaborate with team members from different disciplines and backgrounds.
  • This role requires an individual who is adaptable to changing project requirements and priorities, including the ability to adjust plans and strategies as needed.
Engineering Project Manager

Mechanical Design Engineer

Mechanical Design Engineer

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

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

Location: Stevenage

Report to: VP of Product Development

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

It is an exciting time at MFX Bio as we develop a revolutionary system for the cell and gene therapy market. We are looking to recruit a Mechanical Design Engineer to help us develop this transformative technology. This is a broad role and will involve design activities ranging from consumable design to the mechanical and product design of our hardware.

Our platform will enable ultra-low-cost and scalable CGT production, expediting the journey from discovery to commercialization with unprecedented efficiency. 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.

The Mechanical Design Engineer role will span both the design of prototypes, rigs and also the production design of our products and will ensure best design practices to meet medical device and GMP standards where appropriate.

Responsibilities and duties

  • Help create technical and user requirements of the products
  • Develop designs of prototypes and our products in 3D CAD
  • Analyse and simulate designs using finite element analysis (FEA) and tools such as tolerance analysis
  • Create 2D drawings of designs to share with manufacturing partners
  • Participate in design reviews and design for manufacture assessments
  • Help create quality documentation in support of designs such as dFMEAs
  • Project manage suppliers to manufacture parts
  • Build and test prototypes and rigs and iterate the design as required

Qualifications and Experience:

  • A degree in a mechanical engineering (first or 2:1)
  • 3+ years of experience of 3D CAD modelling preferably using SolidWorks
  • 3+ years of experience designing high volume medical consumables
  • 3+ years of experience of part design for injection moulding
  • 3+ years of experience of creating engineering part and assembly drawings in CAD and applying GD&T
  • Experience of mechanical design of rigs and prototypes
  • Experience of design for manufacture
  • Experience of analysing design using simulation software such as FEA
  • Experience of tolerance analysis
  • Experience in the project managing manufacturing partners

Engineering Project Manager

Analytical Scientist – Bioreactor Analytics and Validation

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

Engineering Project Manager

Software Engineer

Software Engineer

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

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

Location: Hybrid with base location in Stevenage

Report to: Head of Software

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 Software Engineer will design and implement software solutions for all aspects of the products. They will assist software development within the team, ensuring best practices to medical device and GMP standards where appropriate.

The software engineer at 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. 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

  • Understand technical and user requirements of the products.
  • Create, debug, test, document, and deploy software for new products, including software/hardware interfaces, user interfaces, data logging and presentation.
  • Work with the existing software development team.
  • Follow all relevant medical device directives and EU GMP Annex 11 with regards to software.
  • Keep relevant Quality Management System documentation up to date

Qualifications and Experience:

  • 2+ years of experience creating software for a regulated field such as medical devices.
  • 2+ years of experience in writing code in C/C++ and Python.
  • Experience of software development with a strong focus on embedded systems.
  • Experience of electronics, including microcontrollers.
  • A software, electronics or computer sciences degree from a leading university (or equivalent).
  • Experience of machine vision systems and image recognition would be beneficial.
  • Experience of writing code for systems and control engineering.
  • Experience with Linux distributions such as Ubuntu would be beneficial.
  • Experience with real-time operating systems such as FreeRTOS would be beneficial.
  • Experience of designing software that interacts with electromechanical and/or fluid systems and hardware and be able to resolve problems at the interface of these systems would be beneficial