Senior Specialist, Quality Control, Bioassay

Reposted 19 Hours Ago
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2 Locations
In-Office
Senior level
Healthtech • Biotech
The Role
This role involves executing bioassay testing, ensuring compliance with regulatory standards, overseeing testing operations, mentoring staff, and participating in method development.
Summary Generated by Built In

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.

This is a technically advanced, hands-on Quality Control position in which you will execute and support critical bioassay testing for cGMP lot release and stability, along with reviewing test data and analytical outputs. You will also support method qualification, transfers, and troubleshooting while ensuring robust compliance with GDP and cGMP standards. This role is key to sustaining QC readiness and audit preparedness in a dynamic, mRNA-focused testing environment. As a valued member of the QC Bioassay team, you will play a pivotal role in documentation management, deviation investigation, and capacity planning for a rapidly scaling analytical function. The role offers strong exposure to modern molecular techniques and the potential to collaborate closely with digital and GenAI-enabled systems.

Here's What You’ll Do:

Your key responsibilities will be:

  • Perform routine QC Bioassay testing, including molecular and cell biology techniques such as sequencing, qPCR, and electrophoresis, under cGMP conditions.

  • Execute data review of test results including chromatography and analytical outputs, ensuring accuracy and regulatory alignment.

  • Maintain full compliance with GDP, GxP, and internal documentation standards through precise execution of test protocols and documentation practices.

  • Lead method and equipment troubleshooting, supporting cross-functional teams in sustaining testing continuity.

  • Support Certificate of Analysis (CoA) generation and preparation of stability data packages.

Your responsibilities will also include:

  • Author, review, and approve SOPs, test methods, release documents, instrument qualification and validation materials, and method lifecycle documentation.

  • Mentor and support junior QC staff in assay execution and issue resolution.

  • Participate in method transfers and development projects, working closely with technical stakeholders.

  • Drive quality systems investigations including OOS, deviations, CAPAs, and change controls.

  • Assist in developing tools to track QC capacity and turnaround time, aligning resources with operational priorities.

  • Ensure audit readiness and contribute to compliance audit management and responses.

  • Perform and document work in compliance with all internal procedures, Good Documentation Practices, and data integrity standards.

The key Moderna Mindsets you’ll need to succeed in the role:

  • “We digitize everywhere possible using the power of code to maximize our impact on patients.” This role provides a strong opportunity to get close to digital transformation efforts within QC operations, including data systems, trending tools, and platforms supported by automation and Generative AI.

  • “We behave like owners. The solutions we’re building go beyond any job description.” In this role, you will act as a true owner of the QC Bioassay process — not just executing tests, but shaping how data integrity, troubleshooting, and scalability are managed in a complex, fast-paced environment. Your commitment will directly contribute to the reliability of Moderna’s supply chain and the quality of our mRNA medicines.

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.

  • 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.

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

  • Best-in-class 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 [email protected]

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Skills Required

  • BA/BS in a scientific discipline
  • 4+ years of experience or MS with 2 years in Mammalian Cell
  • Experience with cell-based ELISA and in vitro potency assays
  • Working experience in a GMP environment
  • Knowledge of FDA, EU, ICH guidelines and regulations

Moderna Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Moderna and has not been reviewed or approved by Moderna.

  • Fair & Transparent Compensation Pay is commonly characterized as fair, competitive, and a financial positive, with base pay complemented by bonus and other cash elements.
  • Equity Value & Accessibility Long-term rewards commonly include stock options and RSUs, positioning equity as a meaningful part of overall compensation rather than an occasional add-on.
  • Parental & Family Support Family-related support is extensive, including fully paid parental leave, paid family caregiver leave, family-building benefits such as fertility/adoption/surrogacy support, and childcare resources.

Moderna Insights

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The Company
Cambridge, Massachusetts
6,848 Employees
Year Founded: 2010

What We Do

At Moderna, we believe messenger RNA, or mRNA, is the “software of life.” Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients. We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching and could meaningfully improve how medicines are discovered, developed and manufactured. To learn more, visit www.modernatx.com. This Moderna page is not the appropriate place to report adverse events (side-effects) for any products. If you are or someone you know is experiencing a side effect, please reach out to your healthcare professional. Moderna is continuously monitoring the safety of its products. We encourage you to report any side effects directly to us at 1‑866‑MODERNA (1‑866‑663‑3762).

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