Senior Scientist (Assay Development)

About 52 North Health Crowned ‘MedTech Company of the Year’ in the 2023 Cambridge Independent Science and Technology Awards, 52North is developing cutting-edge technologies to reinvent healthcare journeys for all people across the world. Our mission is to help people live better lives, and we do this through innovating, collaborating, and using cutting-edge technology that centres around the people who will engage with it: those living with disease, care givers, doctors, paramedics or nurses. By integrating cutting-edge technology with a human-centred approach, we’re dedicated to revolutionising patient experiences and setting new industry standards. Our solution Neutrocheck is a home-use, low-cost, portable and easy-to-use medical device and app that can identify patients at risk of the most fatal side-effect of chemotherapy treatment: a condition called neutropenic sepsis. Supported by Macmillan Cancer Support and the UK Sepsis Trust, Neutrocheck is expected to save 1000s of lives, and prevent 50,000 unnecessary A&E visits in the UK each year (250,000 in the US), freeing up healthcare provider time, and achieving hundreds of millions in efficiency savings. Opportunity This is a unique opportunity for an Assay Scientist or Biomedical Engineer to take the lead on the development, optimisation, validation and verification of in vitro diagnostic assays. This position will involve collaborative work with our Product Development and Clinical Teams as well as our contract research manufacturer. As a key player in our team, you’ll get to make your mark in our project from day one. We are looking for an organised and flexible team member who is confident and comfortable leading their own project, using initiative and developing the product and business plans, both through independent initiative and as part of an interdisciplinary team. You will have support from our team, partners, and network throughout. And finally, you will be based between the state-of-the-art Cancer Research UK Cambridge Campus on the Cambridge Biomedical Campus and our beautiful main office space in West Cambridge. Position Overview Key Responsibilities: Being responsible for day-to-day lateral flow assay development, including supporting scale up, quality processes, and verification/validation of current assays, as well as laying the groundwork for future pipeline products Managing lab space and documentation within our ISO 13485 quality management system, including working within relevant ISO standards and in vitro diagnostic regulatory frameworks Working closely with clinicians, patients, and engineering partners to design and deliver the product while evaluating and managing risks related to the product Contributing to project management related to assay development, including working closely with our CROs and acting as the first port of call for technical problem solving Collaborating with external partners to prepare regulatory submission documentation Communicating with and contributing to reporting for team members, funders, investors, and collaborators on progress of product development Lead data analysis and interpretation for assay development projects, using statistical methods and bioinformatics tools to ensure accurate and reliable results, and provide actionable insights for product optimisation Qualifications and experience Essential Assay development and lateral flow biochemistry experience within the in vitro diagnostic space Understanding of working within and implementing in vitro diagnostic, QMS and regulatory frameworks including training in such as ISO13485 and ISO9001, IVDR or FDA regulations Demonstrable experience independently managing multi-stakeholder projects, including ability to prioritise time effectively to meet project deadlines Ability to communicate clearly in writing and verbally, with interdisciplinary partners and stakeholders Desirable in one or more of the following areas 3+ years’ of experience educated at least to bachelor’s degree level in a relevant discipline, such as Biochemistry, Biomedical Science, Biomedical Engineering or similar Lab management experience in a regulated environment Technical background in immunology Experience of providing data to support in-person clinical trial development Experience working in a dynamic and quick-paced environment Experience working in biotech or medtech sectors with an understanding of healthcare provider systems Experience evaluating business opportunities Experience in data analysis, including proficiency with statistical software (e.g. R or Python) As a person… You are a clear and effective communicator, able to bring clarity and enthusiasm to any discussion. You have a sense of pride in your work, with a desire to contribute to the success of the team. You are passionate about learning, continuously developing your skills and adapting to new technologies and methods. You maintain a good work-life balance, understanding the importance of relaxation and hobbies alongside your dedication to your career. You thrive in a fast-paced, dynamic environment, able to pivot and adjust as necessary. You are resourceful, consistently finding ways to overcome challenges and solve problems. You have a drive for excellence, consistently striving to improve and innovate. You have a positive and resilient attitude, bringing energy and positivity to the team. You are curious and creative, not afraid to think outside the box and bring new ideas to the table. 52North is an equal opportunity employer and is committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other characteristics protected by law. Benefits At 52North, we believe that our team should be taken care of both in and outside of the office. We offer a robust benefits package, carefully designed to ensure our team members are supported in all aspects of their lives. Our benefits include: Hybrid Working: Enjoy the flexibility of working from home or in our beautiful office space. Flexible Schedule : We understand that everyone has different needs and rhythms. That is why we offer a flexible work schedule. Generous Holiday Allowance: We offer 28 days of paid holiday plus bank holidays every year. On top of that, you will get an extra day off for every two years of service with us. Maternity, Paternity and Adoption Policies: We have comprehensive policies for maternity, paternity, shared parental leave and adoption to support our team members in these life-changing moments. EMI Share Option Scheme: We want our team to be part of our long-term success, so we provide participation in an EMI share option scheme. Pension Scheme: We offer a NEST pension scheme with generous employer contributions. Health Insurance : Our Vitality health insurance provides generous coverage, including physiotherapy, mental health services, and unlimited virtual GP consultations. Dental and Optical Coverage: We cover dental and optical expenses because we know how important complete healthcare is. Wellbeing Engagement Programme: We promote a healthy lifestyle by providing a 50% discount on certain gym memberships and other wellness resources. Social Activities: We foster a close-knit community with social activities throughout the year and multi-day group retreats. Office Perks: Our office is a 15-minute walk from the historical city centre of Cambridge, well connected with public transport and Park & Ride. Enjoy free biscuits, cake, tea, and coffee and soak in the beautiful countryside views that our office offers. If you have strong lab management skills, experience in MedTech product development, and are passionate about state-of-the-art technology, apply now.