Quality Control Associate, Bioassay 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

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

cGMP QC Testing, In Vitro Relative Protein Expression, ELISA, Cell Culture, Transfection, LIMS, Method Qualification, Stability Testing, Good Documentation Practices, Data Integrity, SOP Writing, Out of Specification Investigations, CAPA, Change Control, Bioassay Testing, Cell Biology

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. Join our Quality Control Bioassay team and play a critical role in ensuring the quality, safety, and consistency of Moderna’s innovative mRNA medicines. In this laboratory-based individual contributor role, you will perform cGMP QC testing supporting In Vitro Relative Protein Expression (IVRPE), release and stability testing, while contributing to method qualification, continuous improvement, and operational excellence. Working in a highly regulated GMP environment, you will combine strong scientific expertise with rigorous quality standards to generate reliable analytical data that supports product release and long-term stability. You will also have opportunities to work alongside digital and Generative AI-enabled tools that continue to enhance laboratory operations, data analysis, and scientific decision-making across Moderna. Here's What You'll Do: Perform cGMP Quality Control Bioassay testing with a focus on In Vitro Relative Protein Expression (IVRPE), supporting release and stability programs. Support Method Qualification and Acquisition activities as required. Perform routine analytical bioassay testing supporting Cell Biology, including ELISA methodologies. Execute analytical testing accurately and in accordance with approved procedures and regulatory requirements. Perform general laboratory support activities including reagent preparation, sample management, equipment maintenance, laboratory housekeeping, and ensuring laboratory readiness. Perform LIMS (LabVantage) sample result entry and execute Electronic Assay Forms within LIMS. Support stability programs through timely testing and documentation. Perform data entry and contribute to data trending activities. Manage and maintain QC laboratory supplies and inventory. Assist with troubleshooting analytical methods and laboratory equipment where required. Support investigations related to Out of Specification (OOS) results and other non-conforming events. Participate in quality systems activities including investigations, deviations, change controls, and CAPAs. Write, revise, and maintain Standard Operating Procedures (SOPs), protocols, technical reports, and other controlled documentation. Complete and maintain accurate cGMP documentation for all work performed. Execute work precisely in accordance with Standard Operating Procedures (SOPs), work instructions, and other internal guiding documents. Follow Good Documentation Practices and Data Integrity requirements to ensure records are accurate, complete, and inspection-ready. Ensure compliance with all applicable GxP regulations, internal policies, and regulatory expectations. Establish and maintain a safe laboratory working environment while promoting a culture of quality, compliance, and continuous improvement. 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 digitize everywhere possible using the power of code to maximize our impact on patients. Here’s What You’ll Need (Basic Qualifications) Technical qualification (FP, ciclo superior) or degree in Cell Biology, Molecular Biology, Biochemistry, or other relevant scientific discipline with at least 2 years’ experience Working experience: minimum 2 years’ experience in quality control laboratory of a pharmaceutical company is preferred. Hands-on experience with cell-based assays and biological systems, cell culture, transfection, ELISA or other immunoassays. 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 B2 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

Perform cGMP Quality Control bioassay testing focusing on In Vitro Relative Protein Expression and ELISA to support product release and stability. Manage laboratory operations including documentation, equipment maintenance, and participation in quality system investigations like OOS and CAPAs.