Senior Specialist, Quality Control, Chemistry
11 days ago
Madrid
ppIf you’re interested in this role, please apply in English and include an English version of your Resume/CV. /p h3The Role /h3 pJoining 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. /p h3Here’s What You’ll Do /h3 ul liPerform cGMP Quality Control data review for QC Chemistry, including release and stability testing, while supporting Method Qualification and Acquisition activities as required. /li liSupport method transfers and method development activities to ensure robust analytical capabilities. /li liReview executed assay packages in both paper and electronic formats, including chromatography data and other analytical outputs. /li liEnsure laboratory testing is performed accurately and in full compliance with cGMP, GDP, Data Integrity, and Good Documentation Practices requirements. /li liPerform activities required to maintain GMP compliance across QC laboratory operations. /li liSupport stability program activities, including review of stability data packages and associated documentation. /li liPerform data entry activities and support laboratory data trending. /li liLead troubleshooting activities for analytical methods and laboratory equipment. /li liParticipate in cross-functional planning activities to align QC resources and laboratory constraints with business objectives. /li liSupport and mentor junior team members through technical guidance, troubleshooting, and training. /li liAuthor, 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. /li liDevelop and manage scheduling and status monitoring tools to track testing capacity, turnaround times, and communicate laboratory progress across the organization. /li liProvide compliance guidance and support to the QC Chemistry team, including preparation for, participation in, and response to internal and external compliance audits. /li liPerform and/or support Certificate of Analysis generation and preparation of stability data packages. /li liComplete, review, and maintain cGMP documentation supporting all laboratory activities. /li liLead Quality System records, including investigations, Out of Specification (OOS) events, deviations, change controls, and Corrective and Preventive Actions (CAPAs). /li liExecute work precisely in accordance with internal procedures, Standard Operating Procedures (SOPs), work instructions, and applicable GxP regulations. /li liEnsure documentation, records, and laboratory data are audit-ready and maintained to support regulatory inspections. /li liSupport special projects that contribute to continuous improvement, operational excellence, and laboratory innovation. /li liCollaborate 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. /li /ul h3The key Moderna Mindsets you’ll need to succeed in the role /h3 ul liWe obsess over learning. We don’t have to be the smartest we have to learn the fastest. /li liWe behave like owners. The solutions we’re building go beyond any job description. /li /ul h3Here’s What You’ll Need (Basic Qualifications) /h3 ul liBA/BS in Chemistry (preferred) or other relevant scientific discipline. /li liWorking experience: +5 years experience in quality control laboratory of a pharmaceutical company /li liExperience 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. /li liWorking experience in a GMP environment. /li liWorking knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred. /li liAbility to collaborate effectively in a dynamic, cross-functional matrix environment. /li liAbility to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment. /li liWorking proficiency in English, minimum C1 level required. /li /ul h3Pay Benefits /h3 pAt 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. /p ul liCompetitive healthcare, plus voluntary benefit programs to support your unique needs /li liA holistic approach to well‑being with access to fitness, mindfulness, and mental health support /li liFamily building benefits, including fertility, adoption, and surrogacy support /li liGenerous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year‑end shutdown /li liSavings and investments to help you plan for the future /li liLocation‑specific perks and extras /li /ul pBenefits offered may vary depending on the nature of your employment with Moderna and the country where you work. /p pModerna 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. /p pModerna 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 /p /p #J-18808-Ljbffr
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