Specialist, Quality Control - Chemistry & Stability

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 footprint in Madrid, a city that thrives on creativity and innovation.
As a crucial part of our commercial operations outside the United States, our Madrid office focuses on delivering our groundbreaking products to the Spanish market.
We're seeking professionals who are ready to contribute to our mission and shape the future of mRNA medicines in Spain.
Moderna is seeking a Quality Control Chemistry & Stability Associate II to join our team in Madrid, Spain.
Reporting to the Quality Control Manager, you will play a key role in cGMP QC testing, focusing on QC Chemistry, release, and stability activities.
You will also contribute to the Global GMP stability programs and provide technical support for data management, protocol development, and regulatory submissions.
In this role, you'll perform statistical analyses, ensure compliance with international guidelines, and collaborate on special projects that align with Moderna's cutting-edge mRNA technology and innovative spirit.
Here's What You'll Do Your key responsibilities will be: Conducting trending and statistical analyses per ICH guidelines.
Creating and managing stability protocols, reports, and GMP stability study documents.
Supporting stability chamber maintenance, troubleshooting, and data interpretation.
Assisting with regulatory submissions by providing stability data and reports.
Managing inventories for GMP stability drug substance and products.
Your responsibilities will also include: Coordinating stability pulls, set-downs, and external sample shipments.
Participating in Quality Event resolutions, including Deviations, CAPAs, and Change Controls.
Supporting stability program continuous improvement initiatives.
Compiling metrics for quality management reviews and stability meetings.
Contributing to audits, safety compliance, and cross-functional stability team discussions.
The key Moderna Mindsets you'll need to succeed in the role: We Obsess Over Learning: In the fast-paced field of mRNA technology, your ability to rapidly learn, adapt, and apply innovative approaches will be essential for refining stability programs and data analysis.
We Behave Like Owners: As an individual contributor, you will take full ownership of your responsibilities, driving the stability program's excellence while supporting Moderna's global mission to deliver impactful medicines.
Here's What You'll Need (Minimum Qualifications) BA/BSc in Chemistry (preferred) or other relevant scientific discipline Working experience: at least 5-7 years in quality control laboratory of a pharmaceutical company Hands on experience with analytical chemistry testing including chromatographic techniques- HPLC, UPLC, GC; Spectroscopic and Spectrometric techniques; Physical properties techniques such as Particle Analysis by Dynamic Light Scattering; Titrations techniques and others.
Hands on experience with stability testing and related activities such as: maintaining of stability databases, trending and statistical analyses, creation, revision, review and approval of SOP's, stability protocols and reports in accordance with current GMP, FDA, EU and ICH guidelines and regulations Working experience in a GMP environment.
Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
This position is site-based, requiring you to be at Moderna's site full-time.
This position is not eligible for remote work.
Here's What You'll Bring to the Table (Preferred Qualifications) A desire to make an impact as 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: 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. As we build our company, we have always believed an in-person culture is critical to our success.
Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model.
This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship.
Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
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 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.
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 or adjustments to qualified job applicants with disabilities.
Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at ******.
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