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  • Manager, Regulatory Science, EEMEA  

    Moderna
    - London
    Apply Now
    The Role: Joining Moderna offers the unique opportunity to be part of... Read More
    The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases.As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide.Moderna is solidifying its presence in London, a global hub for scientific research and innovation. Our London office focuses on commercial operations, ensuring the delivery of our revolutionary products to the UK market. We're seeking talents who are ready to contribute to our mission and transform the landscape of health worldwide.In this role, you will be instrumental in shaping and driving regulatory strategies for the Eastern Europe, Middle East, and Africa (EEMEA) region. You will partner closely with the Director of Regulatory Affairs – EEMEA, global regulatory teams, and cross-functional stakeholders to ensure smooth regulatory execution across Moderna’s pipeline and marketed products. This is a unique opportunity to work with Health Authorities across diverse markets, supporting both early development and lifecycle management of mRNA medicines. You will act as a trusted regulatory advisor, managing submissions, post-approval activities, and risk assessment while representing Moderna’s pioneering science externally. By combining strong technical knowledge with collaboration, you will help Moderna navigate complex regulatory pathways and deliver on its mission of transforming patient outcomes. This is an individual contributor role based in London, with a remit spanning the EEMEA region.Here's What You’ll Do:Your key responsibilities will be:Lead regulatory aspects of assigned projects and programs across EEMEA.Support the Director, Head of Regulatory Affairs – EEMEA, Global Regulatory Teams, and Regional/Country Cross-Functional Teams in developing and executing regulatory strategies.Contribute to and oversee the preparation of regulatory submissions, including dossiers, meeting requests, orphan-drug designations, priority review applications, safety reports, and RTQs.Manage post-approval lifecycle activities and commitments of approved products in EEMEA.Your responsibilities will also include:Anticipating and addressing regulatory challenges associated with mRNA as a new drug modality.Maintaining close contact with Health Authorities and partner regulatory teams/consultants.Identifying and assessing regulatory risks for assigned programs.Preparing and delivering effective communications and presentations for internal and external stakeholders.Providing cross-functional regulatory guidance across Moderna’s business activities, from IND through lifecycle management.The key Moderna Mindsets you’ll need to succeed in the role:We obsess over learning. We don’t have to be the smartest we have to learn the fastest. — Regulatory science in EEMEA requires agility and constant learning to adapt to evolving frameworks and diverse authority expectations.We act with urgency; Action today compounds the lives saved tomorrow. — Timely, proactive regulatory engagement is critical to accelerating access to Moderna’s transformative mRNA medicines for patients across EEMEA.Here’s What You’ll Bring to the Table:BA/BS degree in a scientific major (eg. Biology, Biochemical, Bioengineering, Pharmacy) required.10+ years of experience in the Pharmaceutical industry7+ years of experience in Regulatory Affairs Strong knowledge of current EEMEA and International regulations including the US and the EU, related to the clinical, nonclinical, and CMC development of biologic productsStrong experience with CTD format and content of regulatory filingsKnowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance in EEMEAAble to help create and maintain parts of regulatory dossiers including Information for Professionals and Patient and Packaging InformationExperience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplementsAbility to work independently to manage multiple projects in a fast-paced environmentAbility to effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestonesAble to effectively communicate the regulatory strategy, risks, mitigation and overall plans to Project Teams and senior management, as relevantOutstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned. Business level fluency in English is required. Fluency in Arabic is an advantage. A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and CollaborativeAt Moderna, we believe that when you feel your best, you can do your best work.  That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.Quality healthcare and insurance benefitsLifestyle Spending Accounts to create your own pathway to well-beingFree premium access to fitness, nutrition, and mindfulness classesFamily planning and adoption benefitsGenerous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavings and investmentsLocation-specific perks and extras!The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. Read Less
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  • Director, Regional Regulatory Strategist  

    Moderna
    - London
    Apply Now
    The Role: Joining Moderna offers the unique opportunity to be part of... Read More
    The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases.As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide.Moderna is solidifying its presence in London, a global hub for scientific research and innovation. Our London office focuses on commercial operations, ensuring the delivery of our revolutionary products to the UK market. We're seeking talents who are ready to contribute to our mission and transform the landscape of health worldwide.We are seeking a dynamic and forward-thinking Director, Regional Regulatory Strategist to lead the regulatory strategy and execution for interactions with the European Medicines Agency (EMA) for assigned programs. As an individual contributor based in London, you will also collaborate with Country Regulatory Leads across EU and international markets to develop localized regulatory strategies and support global submissions.This is an exciting opportunity for a regulatory professional eager to shape the future of mRNA medicines. The ideal candidate will bring a creative and agile mindset, anticipating challenges inherent in the evolving regulatory landscape for a novel modality like mRNA. Your strategic leadership will ensure robust regulatory planning and engagement, from early-stage filings through lifecycle management, including accelerated pathways and pediatric development strategies.Here's What You’ll Do:Your key responsibilities will be:Serving as the EMA primary contact point for your assigned program(s), leading regulatory engagement strategy across all interactions.Driving the development and execution of EU regulatory strategy in alignment with Global Regulatory Teams and Country Regulatory Leads.Managing content and format for EMA-related regulatory submissions such as meeting requests, briefing documents, orphan drug applications, pediatric plans, MAA, expedited pathways, DSURs, and more.Identifying regulatory risks and mitigation strategies in support of timely approvals and successful lifecycle management of Moderna’s programs.Contributing regulatory expertise to regional and global planning discussions, ensuring integration of EMA requirements into global development plans.Ensuring strong collaboration and knowledge exchange with international teams to support regulatory filings and queries across other global markets.Your responsibilities will also include:Supporting Country Regulatory Leads in the EU and international markets by advising on local regulatory strategy, dossier content, and regulatory authority interactions.Coordinating end-to-end regulatory submission activities related to assigned program(s) to ensure timely and high-quality deliverables.Preparing and delivering impactful communications and presentations to internal stakeholders and health authorities as needed.Providing expert input into key cross-functional initiatives, such as CTA content design and submission planning.Staying informed about evolving EMA regulations, guidance documents, and policy trends impacting mRNA technologies, and proactively adjusting strategy as needed.Helping shape Moderna’s internal regulatory processes for new modalities, driving continuous innovation and regulatory excellence.The key Moderna Mindsets you’ll need to succeed in the role:We question convention because proven models don’t always fuel the future. This role is designed for someone ready to challenge the traditional regulatory playbook and help define the path forward for mRNA medicines in the EU regulatory environment.We digitize everywhere possible using the power of code to maximize our impact on patients. Your work will intersect with digitally enabled platforms and innovative submission strategies. You’ll have opportunities to engage with teams pioneering the use of Generative AI tools to drive regulatory insights and submission planning.Here’s What You’ll Bring to the Table:Degree in Life Science or related discipline, advanced degree preferred (PharmD, MSc, PhD)10+ years of experience in the pharmaceutical industry. 7+ years of experience in Regulatory strategyStrong knowledge of current EU and International regulations from preclinical stage to post-approvalKnowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance in the EU and International countriesExperience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements (i.e., CTD content and format)Ability to work both independently and within project teams, committees, etc. to achieve business goals and objectives in a fast-paced environmentAbility to effectively collaborate effectively in a dynamic, cross-functional, matrixed environment to drive meeting each program’s critical regulatory milestonesEffectively communicate the regulatory strategy, risks, mitigations and overall plans to Project Teams and senior management, as relevantOutstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned.   Fluency in English is required.  The knowledge of other European languages is a plus.A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and CollaborativeAt Moderna, we believe that when you feel your best, you can do your best work.  That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.Quality healthcare and insurance benefitsLifestyle Spending Accounts to create your own pathway to well-beingFree premium access to fitness, nutrition, and mindfulness classesFamily planning and adoption benefitsGenerous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavings and investmentsLocation-specific perks and extras!The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. 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  • Director, Global Regulatory Labeling Strategy  

    Moderna
    - London
    Apply Now
    The Role: Joining Moderna offers the unique opportunity to be part of... Read More
    The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases.As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide.Moderna is solidifying its presence in London, a global hub for scientific research and innovation. Our London office focuses on commercial operations, ensuring the delivery of our revolutionary products to the UK market. We're seeking talents who are ready to contribute to our mission and transform the landscape of health worldwide. Alternatively, the role may be based in Harwell, where Moderna’s state-of-the-art facility is shaping the next chapter in mRNA research, development, and manufacturing.Moderna is seeking a Director, Global Regulatory Labeling Strategy to support our growing pipeline of new programs. Based in the UK (London or Harwell), this role is designed for a future-focused regulatory professional with a sharp, creative mindset, ready to anticipate and overcome the complex challenges involved in rapidly delivering regulatory-compliant labeling for a global portfolio of products. With a geographic remit spanning the United States, European Union, United Kingdom, and Switzerland, the successful candidate will play a pivotal role in shaping global labeling content and strategy across early and late-phase assets.This is an individual contributor role offering deep cross-functional collaboration and exposure to cutting-edge regulatory processes. As part of this role, you will also have opportunities to engage closely with data-driven technologies and explore intersections with Generative AI tools, particularly as they evolve within the regulatory domain.Here’s What You’ll Be Doing:Your key responsibilities will be:Lead the development of Target Label Profiles (TLPs) for early-phase assets, ensuring strategic alignment with clinical and regulatory goals.Drive the creation and accountability of regulatory labeling content for marketing applications (MAAs) and all related supplements and amendments.Develop high-quality labeling that adheres to regulatory requirements and global standards, serving as the subject matter expert for US, EU, UK, and Swiss markets.Own the regulatory review and content development for product artwork, including trade names, established names, logos, and graphics.Interface with cross-functional project teams to embed labeling considerations early and ensure consistent compliance with the Company Core Data Sheet (CCDS).Your responsibilities will also include:Maintain up-to-date knowledge of evolving global labeling regulations and industry trends; proactively communicate implications to stakeholders.Communicate labeling strategies, risk mitigations, and implementation plans clearly to Project Development Teams, Global Regulatory Science Leadership, and senior stakeholders.Act as a thought leader within the regulatory labeling community, representing Moderna in external forums and maintaining strategic awareness of industry shifts.Provide flexible labeling support across the portfolio, offering coverage for other products during peak workload or team member absences.Contribute to the definition and improvement of the end-to-end global labeling process within the regulatory function.The key Moderna Mindsets you’ll need to succeed in the role:We question convention because proven models don’t always fuel the future.
    In this role, you'll be challenged to innovate beyond traditional labeling strategies, especially as you navigate complex, multi-region regulations. You'll be expected to offer bold, data-informed solutions that move faster than standard industry timelines.We digitize everywhere possible using the power of code to maximize our impact on patients.
    You will be well positioned to explore and implement digital tooling to optimize labeling operations, and may contribute to early-stage exploration of Generative AI in labeling workflows and content generation, contributing to broader automation goals.Here’s What You’ll Bring to the Table:Experience facilitating meetings and driving consensus and results.Excellent leadership, communication (verbal and written) and collaboration skills.Proven ability in medical/technical writing.Labeling experience (CCDS, US, EU, UK, other major markets) in rare diseases, oncology and/or vaccines is desirable.Sense of urgency regarding FDA/EMA/MHRA/other HA communications and response timelines to provide coverage for product approvals and labeling negotiations.Integrity: overriding commitment to integrity and high standards for self and others.Results orientationStrategic orientation: ability to link company and departmental visions with daily workInteracts effectively as member of the Regulatory sub-team, communicating effectively on strategies to the Global Labeling Committee and collaborating with business partners, including affiliates and third parties.Flexibility/adaptability: ability to adapt to, and work effectively within, a variety of situations and with various individuals and groups.Relationship building, teamwork and cooperation: builds and maintains strong working relationships with colleagues.Qualifications:BA/BS degree in a scientific discipline required, Master’s or PhD preferred.10+ years of experience in the pharmaceutical industry7+ years of experience in Regulatory labelingStrong knowledge of artwork development, review and approval required.Strong knowledge of current global regulations, including specifically: e.g. vaccine development regulations and registrations pathways.Strong experience with CTD format and content regulatory filingsExceptional written and oral communicationExperience dealing with broad range of stakeholders at all levels internal and external to the company Delivery of labeling for at least one major application (NDA/BLA/MAA/JNDA, etc.)At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.Quality healthcare and insurance benefitsLifestyle Spending Accounts to create your own pathway to well-beingFree premium access to fitness, nutrition, and mindfulness classesFamily planning and adoption benefitsGenerous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavings and investmentsLocation-specific perks and extras!The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. Read Less
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  • Director, Site Engineering Lead  

    Moderna
    - Oxford
    Apply Now
    The Role: Joining Moderna offers the unique opportunity to be part of... Read More
    The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases.As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide.Moderna is solidifying its presence in Harwell, Oxfordshire, as part of a long-term commitment to onshore mRNA vaccine production and innovation in the UK. At our Moderna Innovation and Technology Centre (MITC), we are building a highly skilled team to deliver technical excellence, manufacturing leadership, and scientific advancement. We're inviting global experts to join us in transforming medicine and shaping the future of mRNA therapeutics from our newest state-of-the-art facility in the UK.
    This is a critical leadership opportunity for a forward-thinking engineering expert to help shape the future of Moderna’s UK operations. As Site Engineering Lead at our Moderna Innovation and Technology Centre (MITC) in Harwell, you will serve as a key member of the Site Leadership Team, reporting directly to the Site Head with a dotted line to the SVP of Global Engineering. You will lead the strategic and operational direction of Engineering and Automation across our GMP Drug Substance manufacturing operations and co-located R&D laboratory facilities.This role demands exceptional expertise in process engineering and the ability to deliver both steady-state performance and future-readiness. You will drive the implementation of new technologies, manage technical compliance, build organizational capabilities, and lead engineering excellence that aligns with Moderna’s global vision. With close collaboration across internal global functions and an opportunity to influence our international engineering strategy, this position plays a pivotal role in advancing the impact of mRNA science.Here’s What You’ll Do:Your key responsibilities will be:Lead the Engineering & Automation function for MITC, encompassing process engineering, automation, utilities, maintenance, and metrology.Represent Engineering & Automation on the Site Leadership Team, participating in site-level strategic and operational decision-making.Develop and mentor a multidisciplinary technical team, fostering strength in reliability engineering, technical problem-solving, and advanced process technologies.Provide both strategic leadership and hands-on oversight for engineering initiatives that support routine operations and the introduction of new platforms.Ensure site systems are inspection-ready, compliant with MHRA, EMA, FDA, and internal quality standards.Champion a culture of continuous improvement, focused on process robustness, cost optimization, and equipment lifecycle performance.Guide implementation of preventive and predictive maintenance programs to improve uptime and maximize asset reliability.Support future growth by enabling deployment of new technologies and integrating digital systems aligned with network strategies.Your responsibilities will also include:Drive the successful lifecycle management of all technical systems, ensuring they meet Moderna’s safety, quality, and operational standards.Oversee compliance activities related to GMP documentation: change controls, SOPs, engineering records, deviations, CAPAs, and investigations.Act as the site’s primary technical interface with Global Engineering, MS&T, and Technical Development functions.Collaborate across Quality, Manufacturing, Digital, and EHS teams to ensure readiness, alignment, and seamless execution of engineering initiatives.Contribute actively to global forums to share best practices and influence Moderna’s global engineering strategy.The key Moderna Mindsets you’ll need to succeed in the role:“We digitize everywhere possible using the power of code to maximize our impact on patients.”
    In this role, you will lead the integration of advanced automation and digital technologies into our manufacturing and engineering operations, accelerating our ability to scale, learn, and deliver consistently high performance.“We behave like owners. The solutions we’re building go beyond any job description.”
    This role requires full ownership of the site's technical roadmap, working proactively across global networks and local teams to ensure Moderna’s long-term impact through engineering excellence.Here’s What You’ll Bring to the Table:Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical, or related field) required; Master’s degree preferred.12+ years of experience in pharmaceutical, biotech, or other regulated GMP manufacturing environments.5+ years of engineering leadership experience, including management of multidisciplinary technical teams.Demonstrated expertise in process engineering, with hands-on experience supporting process introduction, troubleshooting, and optimization.Proven experience in technology transfer, equipment commissioning, and implementation of new manufacturing technologies.Familiarity with regulatory expectations (MHRA, EMA, FDA) and experience supporting inspections and audits.Ability to lead cross-functional teams and influence without authority across global, matrixed organizations.Excellent interpersonal, communication, and decision-making skills.At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.Quality healthcare and insurance benefitsLifestyle Spending Accounts to create your own pathway to well-beingFree premium access to fitness, nutrition, and mindfulness classesFamily planning and adoption benefitsGenerous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavings and investmentsLocation-specific perks and extras!The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. Read Less
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  • Associate Director, Regulatory Science, EEMEA  

    Moderna
    - London
    Apply Now
    The Role: Joining Moderna offers the unique opportunity to be part of... Read More
    The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases.As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide.Moderna is solidifying its presence in London, a global hub for scientific research and innovation. Our London office focuses on commercial operations, ensuring the delivery of our revolutionary products to the UK market. We're seeking talents who are ready to contribute to our mission and transform the landscape of health worldwide.As Associate Director, Regulatory Affairs for the EEMEA region, you will be instrumental in steering the strategic direction of regulatory operations in one of Moderna's most dynamic and diverse geographies. This is a unique opportunity for an agile, forward-looking regulatory professional to influence both policy and practice across Eastern Europe, the Middle East, and Africa. Working cross-functionally, you will ensure our regulatory strategy is tightly integrated with Moderna’s long-term goals for mRNA therapeutics. In this individual contributor role, you will bring creativity, leadership, and precision to a fast-moving regulatory landscape—and play a vital part in shaping regional regulatory frameworks that support the future of mRNA innovation.Here's What You’ll Do:Your key responsibilities will be:Define and contribute to the strategic direction of Regulatory Affairs across the EEMEA region.Shape regulatory policy and engagement strategy, ensuring alignment with Moderna’s long-term objectives.Partner with internal and external stakeholders to integrate regulatory strategy with regional and global business goals.Exercise regulatory leadership and decision-making authority in a highly matrixed environment.Act as a thought partner to the EEMEA Regulatory Affairs Director and support oversight of submissions and agency interactions.Your responsibilities will also include:Identify, assess, and solve complex regulatory challenges across functions and geographies using advanced analytical and strategic skills.Drive cross-functional initiatives and promote seamless collaboration across teams to accelerate regulatory success.Proactively engage with EEMEA regulatory authorities and local partners to influence business-critical decisions and policy development.Help manage regulatory impacts on sub-functions and cross-regional processes beyond direct project involvement.Maintain awareness of the evolving regulatory landscape and integrate emerging requirements into Moderna’s EEMEA regulatory framework.The key Moderna Mindsets you’ll need to succeed in the role:“We obsess over learning. We don’t have to be the smartest—we have to learn the fastest.”
    Navigating the varied and evolving regulatory environments in EEMEA demands continuous learning, flexibility, and the ability to synthesize new data rapidly. Your success will hinge on embracing complexity and turning it into opportunity.“We behave like owners. The solutions we’re building go beyond any job description.”
    This is a role that requires a sense of ownership that extends beyond regulatory operations. You will be empowered to shape long-term strategies, guide decision-making, and drive impact that resonates across Moderna’s global platform.Here’s What You’ll Bring to the Table:Degree in Life Science or related discipline (e.g. Pharmacy, Biology, Biochemical, Bioengineering), advanced degree preferred (PharmD, MSc, PhD)10+ years of experience in Regulatory Affairs or related fieldExpertise in biologics, vaccines, Rare or Autoimmune Diseases, and Oncology, with a strong command of current EEMEA regulations.Proven ability to navigate the regulatory landscape, including comprehensive knowledge of EEMEA, US, and EU regulations for biologic products.Exceptional communication skills, with fluency in English, capable of effectively conveying complex regulatory strategies to diverse audiences. Fluency in Arabic is a distinct advantage.A dynamic, collaborative approach to working in a cross-functional matrix environment, with a bold, relentless, curious, and collaborative mindset.Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplementsAbility to effectively collaborate in a dynamic, cross-functional matrix environment to meeting each program’s critical regulatory milestones.At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.Quality healthcare and insurance benefitsLifestyle Spending Accounts to create your own pathway to well-beingFree premium access to fitness, nutrition, and mindfulness classesFamily planning and adoption benefitsGenerous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavings and investmentsLocation-specific perks and extras!The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. Read Less
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  • (Fixed-Term) Manufacturing Associate, Drug Substance - Shift Position  

    Moderna
    - Oxford
    Apply Now
    The Role: Joining Moderna offers the unique opportunity to be part of... Read More
    The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases.As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide.Moderna's mission is to establish a leading-edge research, development, and manufacturing facility at Harwell, as part of a long-term commitment to onshore mRNA vaccine production for respiratory diseases. This initiative will create a multitude of highly skilled jobs and foster collaboration with academic, NHS and government partners across the UK. We're looking for global experts eager to join us in this endeavour, contributing to a future where access to life-saving vaccines is a reality for all.As a Manufacturing Associate at our Harwell site, you will operate cutting-edge production equipment supporting the safe and effective manufacture of Moderna’s mRNA vaccines. Working in compliance with cGMP and health and safety regulations, you will play a pivotal role in ensuring batch quality and process integrity. This position combines scientific and operational expertise with digital fluency, requiring attention to detail, rapid learning agility, and collaborative teamwork. You will directly contribute to innovations and continuous improvement in a technologically advanced production environment, central to Moderna’s mission to transform medicine.Here’s What You’ll Do: Your key responsibilities will be:Operate and monitor production equipment while adhering to cGMP, SOPs, and health and safety proceduresMaintain a clean, compliant, and safe work environment through strict adherence to gowning and housekeeping standardsExecute operations and maintain accurate manufacturing documentation for batch dispositionPerform routine equipment maintenance such as lubrication, filter changes, and mechanical checks using hand-toolsTroubleshoot digital and equipment-related issues rapidly and efficientlyKeep training records and operational logs up to date, ensuring full complianceWork flexibly including off-hours or overtime to support manufacturing schedulesTake part in deviation investigations (RCA), CAPA tasks, and contribute to incident analysesCollaborate closely with QA and other cross-functional teams to meet production KPIsYour responsibilities will also include:Practicing and promoting safe work habits in alignment with Moderna’s safety cultureProactively identifying and reporting safety or compliance concerns to leadershipParticipating in multiple projects and continuous improvement initiativesApplying lean tools and digital platforms to drive operational excellenceEngaging in a fast-paced, matrixed work environment with agility and a problem-solving mindsetThe key Moderna Mindsets you’ll need to succeed in the role:“We digitize everywhere possible using the power of code to maximize our impact on patients.”
    Your comfort in using digital tools and platforms will be essential in Moderna’s highly automated production environment. From troubleshooting to operational logging, you’ll be expected to leverage technology to enhance efficiency and product integrity.“We behave like owners. The solutions we’re building go beyond any job description.”
    In this role, every team member is expected to step up with initiative and accountability. You’ll own your area of operation and contribute beyond task execution, seeking opportunities to improve workflows and patient outcomes through proactive problem-solving.Here’s What You’ll Need: 1+ years of experience in a GMP manufacturing environmentThis position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre-employment check.Here’s What You’ll Bring to the Table:A university degree with a specialization in Pharmaceutical production technology or equivalentExperience with filtration and chromatography, and cold chain management a plusExperience in audit / inspection preparation, understanding Health authority and regulatory guidelinesAbility to collaborate fluidly with peers, leadership and cross-functional support groups requiredExcellent written, oral communication, and organizational skills required.Ability to maintain attention to detail while executing multiple tasks with minimal supervisionDemonstrated commitment to Moderna's values of Bold, Collaborative, Curious, and Relentless, embodying these values in the workplaceAt Moderna, we believe that when you feel your best, you can do your best work.  That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.Quality healthcare and insurance benefitsLifestyle Spending Accounts to create your own pathway to well-beingFree premium access to fitness, nutrition, and mindfulness classesFamily planning and adoption benefitsGenerous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavings and investmentsLocation-specific perks and extras!The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. Read Less
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  • Associate Director, Country Head Quality Assurance - UK & Ireland  

    Moderna
    - London
    Apply Now
    The Role: Joining Moderna offers the unique opportunity to be part of... Read More
    The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases.As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide.Moderna is solidifying its presence in London, a global hub for scientific research and innovation. Our London office focuses on commercial operations, ensuring the delivery of our revolutionary products to the UK market. We're seeking talents who are ready to contribute to our mission and transform the landscape of health worldwide.This is a critical role for a seasoned pharmaceutical quality leader ready to shape Moderna’s UK footprint. As Associate Director, Country Head, Quality – UK, you will hold dual responsibilities as the Responsible Person (RP/RPi) under EU GDP guidelines and as a Qualified Person (QP) under UK GMP standards. Your role will be pivotal in overseeing compliance, release operations, and quality assurance for Moderna’s mRNA vaccine and pharmaceutical products across the UK. You will serve as the lead UK Quality representative, act as the key contact with the MHRA, and manage all national quality activities, ensuring GxP compliance across supply chain, distribution, storage, recall, and batch release. Working closely with global and local Quality teams, you will support regulatory filings, engage in continuous improvement of the Quality Management System, and contribute directly to the safe and effective delivery of Moderna’s breakthrough products in the UK.Here’s What You’ll DoResponsibilities as RP/RPiUndertake duties as Responsible Person on the wholesale Distribution License in compliance with EU Guidelines 2013/C 343/01 to include:Ensuring a QMS is implemented and maintainedFocusing on the management of authorised activities and accuracy and quality of recordsEnsuring initial and continuous training programmes are implemented and maintainedCoordination and promptly performing any recall operations for medicinal productsEnsuring customer complaints are managed effectivelyEnsuring customers and suppliers are approvedApproving any sub-contracted activities which may impact GDPEnsuring self-inspections are performed at regular intervals following a pre-arranged programme and necessary corrective actions are in placeKeeping records of any delegated dutiesDeciding on the final disposition of returned, rejected, recalled or falsified productApproving any returns to saleable stockEnsuring additional requirements imposed on certain products by national law are adhered toRelease of EU imported batchesResponsibilities as QP – Moderna UK EntitiesExecute QP responsibilities, duties, batch certification and disposition for products in the UK as defined in MHRA Guideline  Execute responsibilities on behalf of Moderna UK License.Ensure products are manufacturing in accordance with cGMPs, internal policies/procedures and applicable regulatory requirements and guidance.Maintain thorough and up to date understanding of international regulatory requirements and guidance.Take actions necessary to maintain and extend technical and professional competence in support of QP responsibilities and ensure thorough understanding of any products and processes prior to conducting any QP batch certification and disposition.Understand and support review of investigations, root cause analysis and review and approval of major/critical deviations, complaints and change controls with process and product impact.Support Quality Systems and Compliance on continuous improvement of the Quality Management System (QMS), support quality management review processes, annual product quality reviews, overall inspection readiness and state of control.Establish and maintain effective communication with clients to match internal and external expectations.Interact with Health authorities as it pertains to Moderna’s licenses and regulatory activities.Act as contact person for product defects and recalls for MHRA and any other applicable Health authority and support recall of product if needed.Provides QP GMP declarations in support of regulatory filings and assist in maintaining GMP/GDP regulatory licenses.Perform QP Audits internally and externally of suppliers and contract testing and contract manufacturing organizations and support health authority inspections.Ensure quality systems, processes, specifications, QAAs and SOPs are designed to be appropriate and applied for the development, manufacture, testing and timely release, and distribution of quality product, and consistent with the global quality strategy and meet all relevant regulatory requirements including local and international regulations and applicable standards and guidance’s. Support review of international regulatory filing information to ensure data integrity and regulatory compliance.Key Responsibilities and if appropriate Authorities of the Position:  Serve as Company's Management Representative. Key contact with Governmental Quality contact to ensure appropriate distribution of vaccine in the national health system and resolution of any product quality issues reported Local Implementation and maintenance the company's quality system.Prepare the Quality Reviews and the monitoring of Quality related KPIs.Develop and administer department budgets, schedules, and other administrative functions.Create, update and ensure the thorough application of SOPs.Prepare internal and external audits, inspections, certifications and monitoring of associated CAPAs.Report to local Health Authorities any placing on the national market of a medicine which you consider to be falsified.Be responsible for all interactions with third party logistics provider(s), including the receipt and handling of goods into the warehouse.Complaint management, Deviation management, Risk analysis at local level.Manage pharmaceutical subcontractors: ensuring that the transportation conditions guarantee the appropriate conservation, integrity and security of the products.Implementation and monitoring of the distribution system (contracts, specifications, etc.)Foster a positive and inclusive work culture that promotes collaboration, innovation, and continuous improvement. Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.  Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.  Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.   Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.   Ensure Monitoring of medical samples if necessaryEnsure implementation and monitoring of the distribution system (contracts, specifications, etc.)Ensure stock monitoring (stock forecast, authorization to distribute, declaration in the event of a risk or confirmed shortage, transport conditions, batch recall, returns, etc.)Comprehensive understanding of local Quality requirements, integration of them on the enterprise quality management system and a  broad knowledge of Global quality functions.The key Moderna Mindsets you’ll need to succeed in the role:“We behave like owners. The solutions we’re building go beyond any job description.”
    You will act as the primary Quality authority for Moderna in the UK, owning compliance responsibilities at every level—from audits and batch release to system-wide quality oversight—ensuring Moderna's integrity and performance in a critical market.“We digitize everywhere possible using the power of code to maximize our impact on patients.”
    You will help identify and integrate digital solutions, including data integrity tools and generative AI-enhanced systems, to optimize compliance monitoring, documentation, and continuous improvement in Moderna’s UK quality operations.Here’s What You’ll Need (Basic Qualifications)Education: Minimum: Bachelor’s Degree in relevant scientific discipline.QP Eligibility is a must Experience: Minimum: +10 years significative experience within the pharmaceutical industry (quality, regulatory and pharmacovigilance area)Soft Skills: Influence others internally and/or externally, including other functions. Negotiation skills. Problem solving oriented.Demonstrated aptitude or ability to learn: Able gain a strong understanding of GxP regulations.  At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.Quality healthcare and insurance benefitsLifestyle Spending Accounts to create your own pathway to well-beingFree premium access to fitness, nutrition, and mindfulness classesFamily planning and adoption benefitsGenerous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavings and investmentsLocation-specific perks and extras!The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. Read Less
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  • Scientist, Clinical Biomarker Laboratory, Immuno-assays (cell based)  

    Moderna
    - Oxford
    Apply Now
    The RoleJoining Moderna offers the unique opportunity to be part of a... Read More
    The Role
    Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.
    Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide.Moderna's mission is to establish a leading-edge research, development, and manufacturing facility at Harwell, as part of a long-term commitment to onshore mRNA vaccine production for respiratory diseases. This initiative will create a multitude of highly skilled jobs and foster collaboration with academic, NHS and government partners across the UK. We're looking for global experts eager to join us in this endeavour, contributing to a future where access to life-saving vaccines is a reality for all.Moderna is seeking a talented and driven Scientist to join the Immuno-assays group in Harwell, UK. This hands-on role will serve as a scientific point of contact for cell-based immunoassay development, qualification/validation, and clinical sample testing across multiple therapeutic areas. The successful candidate will bring deep technical expertise in immunology and infectious disease assays, and will support Moderna’s mRNA clinical programs through delivery of high-quality, regulatory-compliant data.
    The Scientist will lead assay development and validation activities, conduct clinical sample analyses under GCP/GLP, and coach junior staff. With access to cutting-edge technologies and collaborative partnerships, this position also presents an exciting opportunity to work close to the forefront of Generative AI applications in laboratory informatics and analytics. As a critical member of the Immuno-assay UK team, the successful candidate will drive scientific excellence, regulatory compliance, and cross-functional collaboration to advance Moderna’s global pipeline.Here's What You’ll Do:Your key responsibilities will be:Serve as the primary analyst for assigned projects, including assay development, qualification/validation, and clinical sample testing under GCP/GLP conditions.Ensure high-quality, regulatory-compliant data is generated to support global clinical trials.Author technical reports, maintain meticulous training and quality records, and communicate findings at project team meetings.Represent the Immunoassay Team as a Subject Matter Expert (SME) and contribute to strategic planning.Evaluate and adopt novel technologies to address complex scientific challenges.Your responsibilities will also include:Collaborate with internal and external stakeholders on assay innovations and operational improvements.Train and coach junior laboratory staff, supporting performance reviews and skill development.Ensure lab compliance with safety protocols and quality systems (GLP, GCP, ISO).Participate in technical conferences and professional development travel, as required.Flexibly accommodate occasional weekend or overtime work to meet critical program needs.The key Moderna Mindsets you’ll need to succeed in the role:“We obsess over learning. We don’t have to be the smartest we have to learn the fastest.”This role demands constant learning—whether adapting to the latest immunological techniques, incorporating regulatory guidance, or understanding complex clinical trial designs. Your ability to learn rapidly and share knowledge will accelerate team performance and assay reliability.“We digitize everywhere possible using the power of code to maximize our impact on patients.”With opportunities to work closely with modern digital systems and explore the intersection of laboratory science and AI-enabled analytics, your computational skills and digital mindset will be crucial in driving Moderna’s data-centric development model.Here’s What You’ll Bring to the Table:Ph.D. > 2 yrs or BSC/MSc with >6 years' experience in immunology, or related field conducting assay validation in clinical Immunology under GLP/GCLP environment.A background in infectious diseases, virology, bacteriology or oncology and experience with handling laboratory pathogens as containment level 3 is an advantage.Experience and deep understanding of cell culture and cell-based assays, particularly bacteriology assays.Strong level of understanding and expertise in design and executing efficacy testing in the context of clinical trialThe ability to work in a cross-functional work environment is critical; strong leadership skills and independence skills are expected.Excellent written, presentation and interpersonal communication skills; ability to influence and collaborate in a team environment and with external stakeholders.Candidate will be curious in exploring new technology, bold in proposing creative experimental designs and ideas. Will work collaboratively with multifunctional teams and will be relentless in pursuing successful outcomesPossess strong computational skills, preferably experienced with Word, Excel, Power Point, GraphPad PrismKnowledge of system software for data analysis and statistical analysis.Experience of working in a regulated environment GLP, GCP, ISO standards is required.As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre-employment check.At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.Quality healthcare and insurance benefitsLifestyle Spending Accounts to create your own pathway to well-beingFree premium access to fitness, nutrition, and mindfulness classesFamily planning and adoption benefitsGenerous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavings and investmentsLocation-specific perks and extras!The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. Read Less
    Apply Now
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