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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 expanding its innovative reach in Harwell, UK, a leading center for scientific research and development. Our state-of-the-art manufacturing site here plays a critical role in advancing our mission of delivering mRNA medicines globally. We invite committed professionals to join our Harwell team and contribute to groundbreaking medical advancements.
A position of great responsibility and impact, the Associate Director for Quality Control at our Harwell manufacturing site is crucial in overseeing the commercial testing functions within the Quality Control department. This role supports raw materials and drug substances testing for mRNA products, encompassing Microbiological and Environmental Monitoring (EM) tests, and extends to method transfer, qualification, and validation activities.
Here's What You’ll Do:
Within 3 Months, You Will…
Gain a comprehensive understanding of Moderna's Quality Control processes and standards, specifically focusing on the nuances of commercial testing functions for mRNA products. This includes familiarization with testing procedures for raw materials, drug substances, Microbiological and EM tests.
Begin actively overseeing the daily operations of the Quality Control commercial program. This will involve directly managing functions related to stability testing, ensuring that all testing is conducted in line with Moderna’s high standards and regulatory compliance.
Start leading the Quality Control laboratory team, getting to know each team member, their specific roles, and functions. This period will include establishing clear communication channels, understanding individual capabilities and areas of expertise, and setting preliminary objectives for the team.
Within 6 Months, You Will…
Implement Lean methodologies within the Quality Control department. This will involve analyzing current processes, identifying areas for efficiency improvements, and suggesting changes that could enhance the overall productivity and effectiveness of testing functions.
Take a lead role in the development and updating of Standard Operating Procedures (SOPs) and laboratory data collection & documentation systems, both paper and electronic. This task will be aimed at ensuring all procedures align with current cGMP compliance requirements.
Begin extensive collaboration with other critical departments, including Analytical Sciences & Technology (AS&T), Global QC, External QC, Quality Assurance, and Regulatory Affairs. These collaborations will focus on supporting drug substance and product testing both internally and at Contract Manufacturing Organizations (CMOs), as well as other quality-related information for stability programs and Annual Product Quality Reviews (APQR).
Within 12 Months, You Will…
Become fully integrated into your role, leading the Quality Control team with effectiveness and confidence. This will involve ongoing management and mentoring of laboratory personnel, fostering their career development and ensuring the team is meeting all performance and quality targets.
Play a pivotal role in overseeing and managing laboratory investigations, change controls, and Corrective and Preventative Actions (CAPAs) related to Quality Control operations. This includes ensuring all QC operations are compliant with relevant regulatory and company standards.
Lead method transfer and qualification activities in close collaboration with AS&T and development groups. This will involve overseeing the transfer of new methods into the QC laboratory, ensuring all methods are robust, validated, and fit for purpose.
Make significant contributions to the budget planning and resource allocation for the QC department, aligning with Moderna’s strategic goals and ensuring efficient use of resources.
Provide essential support during health authority, internal/external, and vendor audits. This includes interfacing with health authorities during site and external inspections, ensuring that the QC department adheres to all relevant FDA, EU, ICH guidelines, and regulations, and demonstrating Moderna’s commitment to maintaining high-quality standards in all operations.
Here’s What You’ll Bring to the Table:
Minimum education required: Bachelor’s Degree in a relevant scientific discipline.
Minimum experience required: 10 + years in applied industry experience; 4-6 years of management/supervisory experience.
Demonstrated proficiency with Quality System Records, Deviations, Change Controls and CAPAs.
Previous supervisory experience is preferred, including testing scheduling and lab project management.
Minimum knowledge required: general laboratory operations, method acquisition, qualification.
Minimum skills required:
Technical writing.
Proficiency with Microsoft Office Programs.
Familiarity with electronic databases (e.g., LIMS, SAP, LMS).
Familiarity with QC operations including bioassay, chemistry, and microbiology.
HPLC Instrumentation/ Software experience is preferred.
Strong written and oral communication skills as well as organizational skills.
Knowledge of industry standards and guidelines, experience supporting compliance audits.
Demonstrated ability to work effectively under established guidelines and instructions.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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Official account of Jobstore.
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 strategic partnership with the UK Government is exemplified by our innovative presence at Harwell. Our mission is to establish a leading-edge research, development, and manufacturing facility, 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 and NHS 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 the Director, Regional Regulatory Strategy for Infectious Diseases at Moderna, you will lead regulatory strategies with the EMA and international agencies for mRNA therapeutics, managing regulatory interactions and marketing authorizations across the EU and other global markets. Your role involves close collaboration with global teams for integrated planning and serving as the primary contact for regional health authorities. You will oversee regulatory submissions, ensure compliance with regional requirements, and provide expert advice on regional regulatory specifics. Additionally, you will mentor a team of regulatory affairs professionals and navigate the unique challenges of novel drug modalities in infectious diseases.
Here's What Youll Do:
Within 3 Months, You Will…
Acquire an in-depth understanding of Moderna's innovative approach in using mRNA technology for therapeutic applications, focusing on the infectious diseases portfolio.
Initiate the development of regulatory strategies tailored to the EU and international markets, ensuring alignment with Moderna's global objectives and the unique aspects of mRNA therapeutics.
Engage in preliminary discussions with the European Medicines Agency (EMA) and other relevant health authorities to establish a foundation for future regulatory interactions.
Begin active collaboration with internal teams, including Clinical Development, Medical Affairs, and Pharmacovigilance, to align on cohesive and integrated regulatory strategies.
Within 6 Months, You Will…
Lead the preparation and submission of key regulatory documents within the region, including INDs, CTAs, MAAs, and health authority queries, ensuring compliance with regional guidelines.
Foster and strengthen relationships with regional health authorities, becoming the primary regulatory contact for Moderna in these regions, and establishing a framework for ongoing positive interactions.
Systematically analyze and interpret regulatory trends and changes in the EU, Asia-Pacific, and Latin America, advising internal teams on potential impacts and strategic responses.
Coordinate with cross-functional teams to ensure that regional regulatory considerations are seamlessly integrated into Moderna’s overarching regulatory plan and product strategy.
Within 12 Months, You Will…
Drive and oversee major regulatory initiatives and submissions, demonstrating success in navigating the regulatory landscape and achieving key milestones.
Assume full responsibility for mentoring and managing the regulatory affairs team within the region, fostering professional development and high-performance standards.
Establish yourself as a key contributor in shaping Moderna’s regulatory strategies and presence in the infectious diseases therapeutic area, influencing regional and global regulatory approaches.
Ensure that Moderna's regulatory strategies in the region are effectively adapted to support the dynamic and evolving landscape of mRNA-based therapeutics in infectious diseases.
Here’s What You’ll Bring to the Table:
Bachelor’s degree in Life Sciences, Pharmacy, or a related field; advanced degree (e.g., PharmD, MSc, PhD) is preferred.
Minimum of 10 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a focus on regional strategy.
Demonstrated success in leading regulatory submissions and health authority interactions.
Comprehensive knowledge of the regulatory environment and guidelines in key regions, including the EU, Asia-Pacific, and Latin America.
Experience in leading and developing teams with strong leadership and interpersonal skills.
Excellent communication abilities, with fluency in English; additional language skills are beneficial.
Strategic thinker with the ability to operate effectively in a fast-paced, global environment.
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
-
Official account of Jobstore.
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 within our international business services hub in Warsaw, Poland, a city renowned for its rich scientific and technological heritage. This hub provides critical functions meeting the growing demand of Moderna’s global business operations. We're inviting professionals from around the world to join our mission and contribute to the future of mRNA medicines.
We are on the lookout for a Senior Director, Global Regulatory Science (GRS) – Project Resilience Lead, who will play a pivotal role in spearheading the regulatory strategy and coordination of execution for Project Resilience across global sites such as the UK, Canada, Australia, and more. This vital position, based in Harwell, UK, is central to our mission of enhancing the production capabilities and distribution of mRNA-based therapeutics and vaccines. By joining us, you will be a key figure in bolstering the resilience of healthcare systems and ensuring direct access to rapid pandemic response capabilities.
Here's What You’ll Do:
Within 3 Months, You Will…
Develop and contribute to the consolidated regulatory deliverables plan for Project Resilience, integrating complex project facets into a cohesive strategy.
Initiate close collaboration with Country Regulatory Leads, ensuring the robustness and timeliness of regulatory plans and activities across various international markets.
Begin diligently maintaining the regulatory progress on the Project Resilience Global Score Card, ensuring all milestones and deliverables are accurately tracked and reported.
Within 6 Months, You Will…
Effectively communicate and present to management all relevant regulatory updates, requests, risks, and potential delays, ensuring transparent and timely information flow.
Identify and assess Project Resilience regulatory risks, coordinate and prepare risk registers, and devise corresponding mitigation plans, playing a key role in proactive risk management.
Support the execution of specific Project Resilience GRS deliverables such as coordinating Health Authority interactions, overseeing submission planning and approval tracking, and participating in cross-functional projects involving Quality, Manufacturing, and Site Leadership.
Within 12 Months, You Will…
Provide critical timeline updates to the GRS Leadership Team, proactively raising Project Resilience topics for endorsement, discussion, or decision, ensuring strategic alignment at all levels.
Prepare and deliver effective and influential communications and presentations tailored for both external and internal audiences, showcasing your strong communication acumen.
Work closely with the Executive Director of GRS Reg-CMC, the respective Resilience country affiliate Regulatory Heads, and facilitate meetings with government and regulatory officials in the Resilience countries, demonstrating leadership and diplomatic skills.
Here’s What You’ll Bring to the Table:
Degree in Life Sciences or related discipline, advanced degree preferred (PharmD, MSc, PhD).
12+ years of experience in the pharmaceutical industry; 8+ years of experience in Global Regulatory CMC strategy.
Good knowledge of current international regulations related to GMP manufacturing, licensing and overall quality principles for innovative medicines, including mRNA technology and gene therapy requirements.
Experience and good understanding of Module 3 content of regulatory submissions.
Experience with manufacturing process tech transfers and registration of new manufacturing sites.
Strong project management and analytical skills.
Ability to bring together various stakeholders and to reconcile different perspectives and priorities.
Ability to work independently to manage multiple projects in a fast-paced environment.
Self-starter with a high level of sense of accountability and ownership on assigned projects.
Ability to effectively collaborate in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones.
Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned.
A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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