Sr. Specialist, Quality Control, Bioassay

Moderna Therapeutics; Madrid; Presencial; EUR 70.000 - 100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Healthcare

Well-being program

Family benefits

Paid time off

Location perks

Descripción de la vacante

Moderna Therapeutics in Madrid seeks a senior QC Bioassay professional to own cGMP data review for Cell‑Based Methods used in release and stability testing. You will ensure data integrity, review records, and drive investigations across QA, Manufacturing, and Digital teams.

As a senior contributor, you will mentor juniors, lead CAPAs and change controls, support method transfers, qualification, validation, and lifecycle activities.

Formación

• BA/BS in a scientific discipline.
• 4+ years Mammalian cell experience (or MS with 2+ years).
• Cell-based ELISA and in-vitro potency assays experience.
• GMP environment experience preferred.
• English proficiency required.

Responsabilidades

• Perform cGMP data review for QC Bioassay testing, focusing on Cell‑Based Methods for release and stability.
• Provide technical and compliance oversight of assay packages and lab records across paper and electronic systems.
• Lead and/or support laboratory investigations, OOS/OOT, deviations, and quality events.
• Lead CAPAs and change controls related to QC Bioassay.
• Support method transfers, qualification, acquisition, validation, and lifecycle activities for Cell‑Based Methods.
• Review, author, and approve GMP documentation including SOPs, reports, and training materials.
• Support stability programs and data trend analyses; investigate atypical results.
• Provide guidance to junior team members and act as senior technical and compliance point of contact.

Conocimientos

Mammalian Cell

ELISA

GMP Experience

English Proficiency

Educación

BA/BS in a scientific discipline

Descripción del empleo

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. This is an opportunity to become a senior technical and compliance voice within QC Bioassay in Madrid, taking ownership of cGMP data review with a particular focus on Cell‑Based Methods supporting release and stability testing. As a senior individual contributor, you will combine deep mammalian cell and bioassay expertise with rigorous application of cGMP, Good Documentation Practices, data integrity, and quality systems. Your impact will extend well beyond data review. You will lead and support complex laboratory investigations and quality events, troubleshoot assays and laboratory systems, and contribute across method transfer, qualification, acquisition, validation, and lifecycle activities. Working across QC, QA, Manufacturing, Technical Development, Digital, and other functions, you will help strengthen the scientific robustness, compliance, and operational performance of QC Bioassay. You will also have opportunities to get closer to Moderna’s evolving digital ecosystem and Generative AI‑enabled tools, exploring how emerging capabilities can support scientific knowledge, data review, trending, documentation, and laboratory efficiency while maintaining the controls required in a regulated GxP environment.

Here’s What You’ll Do:

• Perform cGMP data review for QC Bioassay testing, with a primary focus on Cell‑Based Methods supporting release and stability programs, ensuring accuracy, completeness, data integrity, and compliance with approved methods, specifications, cGMP, and GDP requirements.
• Provide technical and compliance oversight of executed assay packages and associated laboratory records across both paper and electronic systems, ensuring appropriate documentation and timely resolution of identified issues.
• Lead and/or support laboratory investigations, OOS/OOT assessments, deviations, and other quality events associated with QC Bioassay activities, including root cause analysis, impact assessment, identification of corrective and preventive actions, and timely closure of records.
• Lead and/or support CAPAs and change controls related to the QC Bioassay area, ensuring appropriate implementation, effectiveness, and compliance with applicable procedures and regulatory requirements.
• Provide scientific and technical expertise for Cell‑Based Methods, including troubleshooting methods, assays, equipment, and laboratory systems, and support the identification and implementation of sustainable corrective actions.
• Support method transfers, method qualification, method acquisition, validation, and method lifecycle activities, with particular emphasis on Cell‑Based Methods.
• Review, author, and/or approve controlled GMP documentation, including SOPs, protocols, reports, QC release documentation, instrument qualification documentation, training materials, and method lifecycle documents, as applicable.
• Support stability programs, including review of stability testing data, assessment of trends, preparation and review of stability data packages, and investigation of unexpected or atypical results as needed.
• Perform data entry, data verification, and trending activities to support monitoring of assay and laboratory performance and the identification of emerging trends.
• Participate in cross‑functional planning activities to align QC Bioassay priorities, resources, testing capacity, and constraints with manufacturing, release, stability, and broader business objectives.
• Develop, maintain, and/or support scheduling and status‑monitoring tools to provide visibility of testing workload, capacity, turnaround times, priorities, and progress to the broader organization.
• Provide guidance and compliance support to the QC Bioassay team, proactively identifying potential compliance risks and supporting implementation of appropriate actions.
• Support inspection and audit readiness activities, including preparation for regulatory inspections and internal and external audits, provision of supporting documentation, and preparation and follow‑up of responses and commitments.
• As a senior individual contributor, provide technical guidance, coaching, and training to junior team members, particularly in Cell‑Based Methods, cGMP data review, troubleshooting, documentation, and quality systems.
• Serve as a senior technical and compliance point of contact for QC Bioassay, supporting the timely management and escalation of laboratory investigations, deviations, OOS/OOT events, and other quality or operational issues.
• Support continuity of laboratory operations, ensuring appropriate prioritization of testing and quality activities and effective communication across the QC Bioassay organization.
• Collaborate cross‑functionally with QC, QA, Manufacturing, Technical Development, Digital, and other relevant functions to resolve laboratory, technical, quality, and compliance issues.
• Complete and maintain accurate, contemporaneous, and compliant cGMP documentation for all activities performed.
• Follow all applicable GxP regulations, regulatory guidelines, internal procedures, and company policies, ensuring compliance with both regulatory and internal requirements.
• Execute activities in accordance with approved internal procedures, including Standard Operating Procedures, test methods, work instructions, specifications, protocols, and other applicable controlled documents.
• Adhere to Good Documentation Practices and Data Integrity requirements to ensure laboratory data, documentation, and records are accurate, complete, attributable, contemporaneous, and readily available to support routine operations, audits, and regulatory inspections.
• Support special projects, continuous improvement initiatives, and other QC Bioassay activities as assigned, contributing to improvements in laboratory efficiency, compliance, robustness, and operational performance.
• Engage with Moderna’s evolving digital ecosystem and opportunities to use Generative AI‑enabled tools, where appropriate, to support scientific knowledge, data review, trending, documentation, and laboratory efficiency while maintaining the controls, data integrity, and quality standards required within a regulated GxP environment.

Here’s What You’ll Bring to the Table:

• BA/BS in a scientific discipline.
• Working experience: +4 years (or MS in a relevant scientific discipline with 2 years) with a focus in Mammalian Cell.
• Experience with cell‑based ELISA and in‑vitro potency assays.
• Working experience in a GMP environment is preferred.
• 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.
• Proficiency in English (verbal and/or written) required due to global collaboration needs.

Our Working Model

As we build our company, we have always believed that an in‑person culture is critical to our success. This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to our site‑based operations. Working onsite enables real‑time collaboration, strong team connections, direct mentorship, and the hands‑on partnership needed to deliver our mission. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke‑free, alcohol‑free, and drug‑free work environment.

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.

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.

Reasonable Accommodation Notice

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 [e-mail].

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.