Specialist, Quality Control Chemistry & Stability

Specialist, Quality Control Chemistry & StabilityApply locations Madrid - Spain Quality time type Full time posted on Posted 30+ Days Ago job requisition id R17039
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 within our international centre for analytical excellence in Madrid, a city known for its rich scientific heritage. This facility, the largest such center outside the United States, exemplifies our commitment to solidifying our manufacturing network and advancing our promising mRNA product portfolio. We're looking for talents who can contribute to our innovative research and development efforts.
In this role, you will work as part of the Quality Control team based in Madrid, Spain, reporting to the Quality Control Manager. You will be responsible for performing cGMP QC testing for QC Chemistry, release, and stability programs. You will also support global GMP stability programs, including activities such as stability sample set down, pull, and sample shipment/receipt. In addition, you will maintain stability databases, perform data trending and statistical analysis, and contribute to the creation, revision, and review of SOPs, protocols, and reports according to GMP, FDA, EU, and ICH guidelines. This role will provide opportunities to engage in special projects, continuous improvement initiatives, and participate in audits as needed.
Here's What You'll Do Your key responsibilities will be: Performing statistical analysis and trending of stability data following SOPs and ICH guidelines.Creating, reviewing, and revising stability protocols and reports, including specification documents.Managing stability studies in LIMS, performing data entry and review as necessary.Supporting stability chamber maintenance, troubleshooting, and temperature data interpretation.Your responsibilities will also include: Ensuring the organization and maintenance of stability chambers and walk-ins.Assisting in the shipment and receipt of samples for external testing or storage.Managing GMP stability schedules and sample pulls to meet deadlines.Participating in audits and contributing to regulatory submissions and reports.Engaging in the continuous improvement of stability programs and compiling relevant metrics.Supporting reference standard and cell bank stability programs and ensuring compliance with cGMP and safety standards.The key Moderna Mindsets you'll need to succeed in the role: We prioritize the platform: In this role, you will support Moderna's mission by ensuring the seamless execution of QC and stability programs that uphold the quality and reliability of mRNA-based medicines.We question convention: You will thrive by bringing innovative solutions to improve stability operations and QC processes, challenging existing norms in the pharmaceutical space.Here's What You'll Need (Minimum Qualifications) BA/BSc in Chemistry (preferred) or other relevant scientific disciplineWorking experience: at least 5-7 years in quality control laboratory of a pharmaceutical companyHands 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 regulationsWorking 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 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, and a discretionary year-end shutdownEducational resourcesSavings 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.
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.
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.

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