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:
- Quality healthcare and insurance benefits
- Lifestyle Spending Accounts to create your own pathway to well-being
- Free premium access to fitness, nutrition, and mindfulness classes
- Family planning and adoption benefits
- Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
- Educational resources
- Savings and investments
- Location-specific perks and extras!
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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