Senior Specialist, Quality Control, Chemistry at Moderna

Madrid, Community of Madrid, Spain -

Full Time

Start Date

Immediate

Expiry Date

03 Oct, 26

Salary

0.0

Posted On

05 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

cGMP Data Review, HPLC, UPLC, Spectroscopy, Spectrometry, Dynamic Light Scattering, Method Qualification, Method Transfer, Stability Testing, Data Integrity, GDP, OOS Investigations, CAPA, SOP Authoring, Computer System Validation, Technical Mentoring

Industry

Biotechnology Research

Description

If you’re interested in this role, please apply in English and include an English version of your Resume/CV. The Role: Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna is strengthening its international centre for analytical excellence in Madrid, the largest of its kind outside the United States. The site supports our global manufacturing network and advancing mRNA portfolio. We welcome talent ready to drive innovative research and development. In this individual contributor role, you will play a critical part in ensuring the quality, integrity, and compliance of QC Chemistry activities supporting release and stability testing across our mRNA portfolio. You will combine deep analytical expertise with a strong quality mindset to review complex cGMP data, support laboratory operations, and continuously improve quality systems. Working across functions, you will help strengthen laboratory excellence while contributing to innovative technologies and gaining exposure to advanced digital and Generative AI-enabled approaches that continue to evolve quality and laboratory operations. Here's What You'll Do: Perform cGMP Quality Control data review for QC Chemistry, including release and stability testing, while supporting Method Qualification and Acquisition activities as required. Support method transfers and method development activities to ensure robust analytical capabilities. Review executed assay packages in both paper and electronic formats, including chromatography data and other analytical outputs. Ensure laboratory testing is performed accurately and in full compliance with cGMP, GDP, Data Integrity, and Good Documentation Practices requirements. Perform activities required to maintain GMP compliance across QC laboratory operations. Support stability program activities, including review of stability data packages and associated documentation. Perform data entry activities and support laboratory data trending. Lead troubleshooting activities for analytical methods and laboratory equipment. Participate in cross-functional planning activities to align QC resources and laboratory constraints with business objectives. Support and mentor junior team members through technical guidance, troubleshooting, and training. Author, review, and approve SOPs, analytical test methods, QC release documentation, instrument qualification documentation, computer system validation documentation, training materials, and method lifecycle documentation as required. Develop and manage scheduling and status monitoring tools to track testing capacity, turnaround times, and communicate laboratory progress across the organization. Provide compliance guidance and support to the QC Chemistry team, including preparation for, participation in, and response to internal and external compliance audits. Perform and/or support Certificate of Analysis generation and preparation of stability data packages. Complete, review, and maintain cGMP documentation supporting all laboratory activities. Lead Quality System records, including investigations, Out of Specification (OOS) events, deviations, change controls, and Corrective and Preventive Actions (CAPAs). Execute work precisely in accordance with internal procedures, Standard Operating Procedures (SOPs), work instructions, and applicable GxP regulations. Ensure documentation, records, and laboratory data are audit-ready and maintained to support regulatory inspections. Support special projects that contribute to continuous improvement, operational excellence, and laboratory innovation. Collaborate with colleagues across Quality, Manufacturing, and Technical Development to deliver high-quality analytical support while embracing emerging digital technologies, including opportunities to leverage Generative AI tools where appropriate to improve efficiency and knowledge sharing. 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. We behave like owners. The solutions we’re building go beyond any job description. Here’s What You’ll Need (Basic Qualifications): BA/BS in Chemistry (preferred) or other relevant scientific discipline. Working experience: +5 years experience in quality control laboratory of a pharmaceutical company Experience with analytical chemistry review including chromatographic techniques- HPLC, UPLC, Spectroscopic and Spectrometric techniques; Physical properties techniques such as Particle Analysis by Dynamic Light Scattering and others. 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. Working proficiency in English, minimum C1 level required. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. Competitive healthcare, plus voluntary benefit programs to support your unique needs A holistic approach to well-being with access to fitness, mindfulness, and mental health support Family building benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investments to help you plan for the future 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 opportunity in employment 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 consider qualified applicants regardless of criminal histories, consistent with legal requirements. We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodation 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 leavesandaccommodations@modernatx.com. - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home

Responsibilities

Ensure the quality and compliance of QC Chemistry activities for mRNA release and stability testing through rigorous cGMP data review. Lead troubleshooting for analytical methods and manage quality system records including deviations and CAPAs.