Imubiosciences
IMU Biosciences is a cutting-edge biotech company advancing immune profiling and precision diagnostics through proprietary AI-driven technology. Our platform enables deep immune system characterisation to support the development of next-generation diagnostics and precision medicine applications. By integrating high-dimensional immune data with machine learning, we aim to redefine disease classification and improve patient outcomes. IMU Biosciences partners with leading research institutions, biotech, and pharma companies to bring innovative solutions to clinical practice. We are a multidisciplinary team of world-leading scientists, software engineers, and statisticians who are passionate about changing the face of medicine by leveraging the power and insight of the immune system. We value diversity, ingenuity, and willingness to take the initiative. We are a series A company, with state-of-the-art laboratories in central London and we are looking for talented, motivated, enthusiastic and experienced individuals to join our team. Role Overview We are seeking a highly experienced Head of Quality to lead the construction and ongoing maintenance of the quality management system (QMS) ensuring compliance with regulatory requirements and supporting regulatory submissions in all chosen jurisdictions. The successful candidate should have a strong background in standards such as ISO 13485, to ensure quality and compliance in our product development and implementation. They should have experience managing the QMS, conducting internal and external audits and implementing CAPA processes to drive continuous improvement. A solid understanding on risk management (ISO 14971), validation (IQ, OQ, PQ) and GCLP principles is essential. The candidate must possess strong problem-solving skills, attention to detail, the ability to work autonomously and have excellent interpersonal skills to collaborate with cross-functional teams, suppliers and regulatory bodies to maintain product safety and efficacy. The successful candidate will be lead auditor trained, have proven hand-on knowledge of creating a successful QMS and be able to train at all levels within IMU Biosciences. Initially this role will report to the COO. Our laboratory is situated in our head office in Canary Wharf. In this role you will need to be full time and working at the office in-person, at least 3 times a week, during typical working hours. This role will also require occasional travel owing to international lab setup. Responsibilities ISO 13485 compliance and quality management system (QMS) maintenance Build the QMS to ISO 13485 and CFR 820 Ensure full compliance with ISO 13485:2016 and 21 CFR 820. Oversee, manage and improve the QMS, ensuring its effectiveness and continuous improvement. Keep up to date with regulatory changes and implement necessary adjustments. Training and quality awareness Provide quality training to employees on ISO 13485 requirements and best practices. Promote a quality-driven culture of continuous improvement and regulatory compliance within the organisation. Conduct and ensure GCLP- training for personnel handling biological samples and their data. Document control and record management Develop, maintain, update and control all quality-related documentation including policies and SOPs, ensuring traceability and compliance with ISO 13485. Oversee and ensure accurate record-keeping of inspections and regulatory submissions. Participate in risk management activities in accordance with ISO 14971 (Risk Management for Medical Devices). Identify potential quality risks and implement mitigation strategies. Validation and verification activities Be a core team member for the validation and verification of product and product-related processes, equipment and software used. Ensure compliance with IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) processes. Process and product quality control Monitor product-related processes to ensure product quality, consistency and compliance. Work closely with all teams (especially laboratory, engineering and data teams) to validate processes, resolve quality issues and implement process improvements. Identify areas for process optimisation and efficiency improvements. Supplier and vendor quality assurance Conduct supplier evaluations and/or audits to ensure compliance with ISO 13485. Work with suppliers to maintain supply demand. Collaborate with suppliers to resolve non-conformances and implement quality improvements. Internal and external audits This candidate must be Lead Auditor Trained Conduct and conduct internal audits to assess compliance with ISO 13485. Coordinate and support external audits from regulatory bodies, notified bodies, or customers. Ensure effective implementation of corrective and preventive actions (CAPA) following audits. Host any onsite audits by suppliers and regulatory authorities Non-conformance and CAPA management Investigate and track non-conformances (NCs), deviations and out-of-specification (OOS) results. Lead root cause analysis (RCA) and drive the implementation of CAPA to assess effectiveness of corrective and preventative actions to prevent recurrence. Regulatory and customer complaint handling Investigate and manage customer complaints and implement necessary corrective actions. Ensure compliance with regulatory reporting requirements for medical device incidents (e.g., MDR, FDA). Work with the regulatory affairs team to address compliance issues and maintain market approval. The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope, purpose and grading of the post. Skills, knowledge and experience Bachelor's degree (or higher) in biotechnology, biomedical science, biochemistry, immunology or a related field or proven experience working in quality management systems for medical devices. Strong knowledge and hands on experience with building and managing ISO 13485:2016/21 CFR 820 compliant quality management systems. Working knowledge of GCLP (good clinical laboratory practice) and relevant regulatory requirement (e.g. FDA 21 CFR Part 820). Working knowledge of ISO 14971 Hands-on involvement in regulatory inspections and audits from notified bodies or government agencies. Experience in writing, reviewing and implementing quality-relating documents, such as quality manual, policy documents and SOPs. Excellent interpersonal and communication skills to liaise with cross-functional teams. Proactive/autonomous. Ability to train and mentor staff on quality procedures and regulatory requirements. Excellent organisational and time management skills, with the ability to manage multiple priorities to meet deadlines under pressure. Able to work flexible hours when necessary. Great problem-solving skills to accurately resolve issues. High level of integrity, accountability and attention to detail. Passion for the life sciences industry and a commitment to scientific innovation. At least 8 years' experience leading medical device QMS Proven experience working in an accredited laboratory/company. Previous involvement in complaint handing and risk management Experience working with electronic quality management system (eQMS). Competitive salary depending on experience Enroll in a bonus scheme Fast-paced startup culture where everyone's perspective truly matters Excellent opportunities for advancement as the company grows Working on cutting edge of translational research Embedding in a talented multidisciplinary team How to apply Send us your CV and a short note about why this role feels right to you . If you have links to code, notebooks, or publications - great. If not, no problem. We care more about how you think than how polished your resume is.
IMU Biosciences is a cutting-edge biotech company advancing immune profiling and precision diagnostics through proprietary AI-driven technology. Our platform enables deep immune system characterisation to support the development of next-generation diagnostics and precision medicine applications. By integrating high-dimensional immune data with machine learning, we aim to redefine disease classification and improve patient outcomes. IMU Biosciences partners with leading research institutions, biotech, and pharma companies to bring innovative solutions to clinical practice. We are a multidisciplinary team of world-leading scientists, software engineers, and statisticians who are passionate about changing the face of medicine by leveraging the power and insight of the immune system. We value diversity, ingenuity, and willingness to take the initiative. We are a series A company, with state-of-the-art laboratories in central London and we are looking for talented, motivated, enthusiastic and experienced individuals to join our team. Role Overview We are seeking a highly experienced Head of Quality to lead the construction and ongoing maintenance of the quality management system (QMS) ensuring compliance with regulatory requirements and supporting regulatory submissions in all chosen jurisdictions. The successful candidate should have a strong background in standards such as ISO 13485, to ensure quality and compliance in our product development and implementation. They should have experience managing the QMS, conducting internal and external audits and implementing CAPA processes to drive continuous improvement. A solid understanding on risk management (ISO 14971), validation (IQ, OQ, PQ) and GCLP principles is essential. The candidate must possess strong problem-solving skills, attention to detail, the ability to work autonomously and have excellent interpersonal skills to collaborate with cross-functional teams, suppliers and regulatory bodies to maintain product safety and efficacy. The successful candidate will be lead auditor trained, have proven hand-on knowledge of creating a successful QMS and be able to train at all levels within IMU Biosciences. Initially this role will report to the COO. Our laboratory is situated in our head office in Canary Wharf. In this role you will need to be full time and working at the office in-person, at least 3 times a week, during typical working hours. This role will also require occasional travel owing to international lab setup. Responsibilities ISO 13485 compliance and quality management system (QMS) maintenance Build the QMS to ISO 13485 and CFR 820 Ensure full compliance with ISO 13485:2016 and 21 CFR 820. Oversee, manage and improve the QMS, ensuring its effectiveness and continuous improvement. Keep up to date with regulatory changes and implement necessary adjustments. Training and quality awareness Provide quality training to employees on ISO 13485 requirements and best practices. Promote a quality-driven culture of continuous improvement and regulatory compliance within the organisation. Conduct and ensure GCLP- training for personnel handling biological samples and their data. Document control and record management Develop, maintain, update and control all quality-related documentation including policies and SOPs, ensuring traceability and compliance with ISO 13485. Oversee and ensure accurate record-keeping of inspections and regulatory submissions. Participate in risk management activities in accordance with ISO 14971 (Risk Management for Medical Devices). Identify potential quality risks and implement mitigation strategies. Validation and verification activities Be a core team member for the validation and verification of product and product-related processes, equipment and software used. Ensure compliance with IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) processes. Process and product quality control Monitor product-related processes to ensure product quality, consistency and compliance. Work closely with all teams (especially laboratory, engineering and data teams) to validate processes, resolve quality issues and implement process improvements. Identify areas for process optimisation and efficiency improvements. Supplier and vendor quality assurance Conduct supplier evaluations and/or audits to ensure compliance with ISO 13485. Work with suppliers to maintain supply demand. Collaborate with suppliers to resolve non-conformances and implement quality improvements. Internal and external audits This candidate must be Lead Auditor Trained Conduct and conduct internal audits to assess compliance with ISO 13485. Coordinate and support external audits from regulatory bodies, notified bodies, or customers. Ensure effective implementation of corrective and preventive actions (CAPA) following audits. Host any onsite audits by suppliers and regulatory authorities Non-conformance and CAPA management Investigate and track non-conformances (NCs), deviations and out-of-specification (OOS) results. Lead root cause analysis (RCA) and drive the implementation of CAPA to assess effectiveness of corrective and preventative actions to prevent recurrence. Regulatory and customer complaint handling Investigate and manage customer complaints and implement necessary corrective actions. Ensure compliance with regulatory reporting requirements for medical device incidents (e.g., MDR, FDA). Work with the regulatory affairs team to address compliance issues and maintain market approval. The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope, purpose and grading of the post. Skills, knowledge and experience Bachelor's degree (or higher) in biotechnology, biomedical science, biochemistry, immunology or a related field or proven experience working in quality management systems for medical devices. Strong knowledge and hands on experience with building and managing ISO 13485:2016/21 CFR 820 compliant quality management systems. Working knowledge of GCLP (good clinical laboratory practice) and relevant regulatory requirement (e.g. FDA 21 CFR Part 820). Working knowledge of ISO 14971 Hands-on involvement in regulatory inspections and audits from notified bodies or government agencies. Experience in writing, reviewing and implementing quality-relating documents, such as quality manual, policy documents and SOPs. Excellent interpersonal and communication skills to liaise with cross-functional teams. Proactive/autonomous. Ability to train and mentor staff on quality procedures and regulatory requirements. Excellent organisational and time management skills, with the ability to manage multiple priorities to meet deadlines under pressure. Able to work flexible hours when necessary. Great problem-solving skills to accurately resolve issues. High level of integrity, accountability and attention to detail. Passion for the life sciences industry and a commitment to scientific innovation. At least 8 years' experience leading medical device QMS Proven experience working in an accredited laboratory/company. Previous involvement in complaint handing and risk management Experience working with electronic quality management system (eQMS). Competitive salary depending on experience Enroll in a bonus scheme Fast-paced startup culture where everyone's perspective truly matters Excellent opportunities for advancement as the company grows Working on cutting edge of translational research Embedding in a talented multidisciplinary team How to apply Send us your CV and a short note about why this role feels right to you . If you have links to code, notebooks, or publications - great. If not, no problem. We care more about how you think than how polished your resume is.
Imubiosciences
Business Development 8 Sep 2025 Remote / London UK Office Hybrid Position Information This is an exciting opportunity to join us and contribute to the success at IMU Biosciences - a cutting edge and fast-paced biotech company enabling and delivering a new dimension of immune-system driven precision medicine. IMU is recruiting a results-driven Business Development Director who will report to the CBO. The successful candidate will be responsible for lead generation and building deals with our partners across pharmaceutical companies, biotech and academia to deliver a new era of precision medicine for patients. Job Description This is a key position for IMU Biosciences. The successful candidate must be comfortable, motivated and able to collaborate closely with colleagues across disciplines (laboratory, scientific, bioinformatics, legal and commercial) and seniority to formulate, articulate, position and deliver high value partnerships for IMU. These partnerships will focus on those with a commercial component but include others that may be more focussed on proof-of-concept value creation in collaboration with the clinical research community. The successful candidate must have a strong passion for innovation, collaboration and translating cutting edge science to the benefit of multiple stakeholders including pharma, biotech, patients, clinicians, payers and IMU colleagues and shareholders. A strong business development track record is essential, including full ownership of the deal cycle including structuring, negotiation and closing. Contribute to the business development strategy through the identification, definition, quantification and prioritisation of high value applications for the IMU platform. Identify, negotiate and close commercial relationships with partners across pharma, biotech and academia. Support the development of platform proof of principle data sets through identifying and closing partnerships with the clinical research community and others. Manage the sales/partnership cycle; including the identification and qualification of leads, proposal generation and refinement and contract negotiation and closure - all in close partnership with and support from colleagues as needed. Ensure that partners have an exceptional experience collaborating with IMU Biosciences. Build relationships with partners and the wider community to develop a deep understanding of the needs and challenges in the field that may be addressable by IMU Biosciences. Represent IMU Biosciences at key meetings, conferences and directly with partners. Maintain accurate records to enable deal pipeline reporting and management. Support the design and delivery of collateral materials (including Brochures, White Papers and Application Notes) in support of the business development and partnering objectives. Meet and exceed agreed performance metrics including but not limited to sales and revenue goals. Network, Skills and Abilities Business Development related A strong network across pharma and biotech R&D leaders and decision makers - with a preference for those in the clinical translational space (PD biomarkers, efficacy, safety etc). A strong track record of identifying, negotiating and closing commercial deals. Able to navigate and identify key decision makers and budget holders in biotech as well as large pharma companies. Ideally also experience with identifying, negotiating, and closing research partnership deals with academia/not for profit organisations involving data/IP sharing provisions. An ability to listen to and understand partners' needs and craft a solution that delivers for all stakeholders. Well organised and familiar with managing deal flow and pipeline within a CRM environment. An ability to understand, simplify and communicate scientific concepts and applications to diverse audiences, both verbally and in written form. Able to research, define and quantify platform application opportunities and markets. Able to formulate a plan to address the above target markets and audiences. Experience with content marketing including, for example, the development and delivery of Brochures, Application Notes and/or White Papers. Other Self-motivated and strategic thinker capable of working within a fast-paced biotech and able to collaborate within multi-disciplinary teams. Able to distil complex science and present and articulate the value proposition of IMU Biosciences as it may engage a partner's specific needs. Ability to receive and synthesize multiple inputs to reach informed and reasoned decisions. Able and comfortable interacting with internal and external stakeholders at any level of seniority. Able to time manage and prioritise parallel projects. A broad understanding of needs and drivers in the translational and biomarker space as applied to supporting clinical studies and trials would be ideal. A background/experience (scientific and/or BD) in a relevant field(s) such as immunology, cell therapy, immuno-oncology, immune homeostasis/auto-immune disease or related would be an advantage but is not essential. Qualifications Minimum BSc or MSc in a Life Sciences discipline. Preferably a PhD and/or other advanced degree (MBA). Greater than 6 years of post PhD experience inone or more of the pharmaceutical / biotech, management consultancy, VC, tech transfer or related business areas, including a minimum of 4 years' business development experience with a proven ability to identify and close deals with pharma, biotech or academia partners. Other requirements The role is remote however the successful candidate will be expected to be on-site at IMU's office and laboratories in London for at least one day per week. Must be located in the UK and preferably in the Oxford / Cambridge / London area. Must be willing and able to travel for business (approximately 20% of the time): UK, Europe, US and AsiaPac. IMU Biosciences offers a competitive package. Base salary offered will be subject to the skills and experience of the individual. The package will also include a discretionary annual results-driven bonus, Share Options and other benefits. To apply please send a cover letter and CV to: We do not accept unsolicited emails from recruitment agencies. About IMU Biosciences IMU Biosciences has developed proprietary platform technologies that generate and translate vast system-level immune data into actionable insights and tools to drive the development of precision medicines across a variety of diseases. Built on over a decade of research at King's College London and the Francis Crick Institute, IMU leverages advanced immune profiling with proprietary AI and machine learning analytics to uncover novel clinical immune signatures. IMU continues to establish partnerships with leading pharma and biotech companies to advance disease diagnosis, optimise product selection, and improve patient stratification and monitoring - while also building its own pipeline of innovative products.
Business Development 8 Sep 2025 Remote / London UK Office Hybrid Position Information This is an exciting opportunity to join us and contribute to the success at IMU Biosciences - a cutting edge and fast-paced biotech company enabling and delivering a new dimension of immune-system driven precision medicine. IMU is recruiting a results-driven Business Development Director who will report to the CBO. The successful candidate will be responsible for lead generation and building deals with our partners across pharmaceutical companies, biotech and academia to deliver a new era of precision medicine for patients. Job Description This is a key position for IMU Biosciences. The successful candidate must be comfortable, motivated and able to collaborate closely with colleagues across disciplines (laboratory, scientific, bioinformatics, legal and commercial) and seniority to formulate, articulate, position and deliver high value partnerships for IMU. These partnerships will focus on those with a commercial component but include others that may be more focussed on proof-of-concept value creation in collaboration with the clinical research community. The successful candidate must have a strong passion for innovation, collaboration and translating cutting edge science to the benefit of multiple stakeholders including pharma, biotech, patients, clinicians, payers and IMU colleagues and shareholders. A strong business development track record is essential, including full ownership of the deal cycle including structuring, negotiation and closing. Contribute to the business development strategy through the identification, definition, quantification and prioritisation of high value applications for the IMU platform. Identify, negotiate and close commercial relationships with partners across pharma, biotech and academia. Support the development of platform proof of principle data sets through identifying and closing partnerships with the clinical research community and others. Manage the sales/partnership cycle; including the identification and qualification of leads, proposal generation and refinement and contract negotiation and closure - all in close partnership with and support from colleagues as needed. Ensure that partners have an exceptional experience collaborating with IMU Biosciences. Build relationships with partners and the wider community to develop a deep understanding of the needs and challenges in the field that may be addressable by IMU Biosciences. Represent IMU Biosciences at key meetings, conferences and directly with partners. Maintain accurate records to enable deal pipeline reporting and management. Support the design and delivery of collateral materials (including Brochures, White Papers and Application Notes) in support of the business development and partnering objectives. Meet and exceed agreed performance metrics including but not limited to sales and revenue goals. Network, Skills and Abilities Business Development related A strong network across pharma and biotech R&D leaders and decision makers - with a preference for those in the clinical translational space (PD biomarkers, efficacy, safety etc). A strong track record of identifying, negotiating and closing commercial deals. Able to navigate and identify key decision makers and budget holders in biotech as well as large pharma companies. Ideally also experience with identifying, negotiating, and closing research partnership deals with academia/not for profit organisations involving data/IP sharing provisions. An ability to listen to and understand partners' needs and craft a solution that delivers for all stakeholders. Well organised and familiar with managing deal flow and pipeline within a CRM environment. An ability to understand, simplify and communicate scientific concepts and applications to diverse audiences, both verbally and in written form. Able to research, define and quantify platform application opportunities and markets. Able to formulate a plan to address the above target markets and audiences. Experience with content marketing including, for example, the development and delivery of Brochures, Application Notes and/or White Papers. Other Self-motivated and strategic thinker capable of working within a fast-paced biotech and able to collaborate within multi-disciplinary teams. Able to distil complex science and present and articulate the value proposition of IMU Biosciences as it may engage a partner's specific needs. Ability to receive and synthesize multiple inputs to reach informed and reasoned decisions. Able and comfortable interacting with internal and external stakeholders at any level of seniority. Able to time manage and prioritise parallel projects. A broad understanding of needs and drivers in the translational and biomarker space as applied to supporting clinical studies and trials would be ideal. A background/experience (scientific and/or BD) in a relevant field(s) such as immunology, cell therapy, immuno-oncology, immune homeostasis/auto-immune disease or related would be an advantage but is not essential. Qualifications Minimum BSc or MSc in a Life Sciences discipline. Preferably a PhD and/or other advanced degree (MBA). Greater than 6 years of post PhD experience inone or more of the pharmaceutical / biotech, management consultancy, VC, tech transfer or related business areas, including a minimum of 4 years' business development experience with a proven ability to identify and close deals with pharma, biotech or academia partners. Other requirements The role is remote however the successful candidate will be expected to be on-site at IMU's office and laboratories in London for at least one day per week. Must be located in the UK and preferably in the Oxford / Cambridge / London area. Must be willing and able to travel for business (approximately 20% of the time): UK, Europe, US and AsiaPac. IMU Biosciences offers a competitive package. Base salary offered will be subject to the skills and experience of the individual. The package will also include a discretionary annual results-driven bonus, Share Options and other benefits. To apply please send a cover letter and CV to: We do not accept unsolicited emails from recruitment agencies. About IMU Biosciences IMU Biosciences has developed proprietary platform technologies that generate and translate vast system-level immune data into actionable insights and tools to drive the development of precision medicines across a variety of diseases. Built on over a decade of research at King's College London and the Francis Crick Institute, IMU leverages advanced immune profiling with proprietary AI and machine learning analytics to uncover novel clinical immune signatures. IMU continues to establish partnerships with leading pharma and biotech companies to advance disease diagnosis, optimise product selection, and improve patient stratification and monitoring - while also building its own pipeline of innovative products.