QA Technical Operations Lead - Drug Substance

The Role:

Reporting to the Site Quality Head, the QA Technical Operations Lead will be part of a cohesive team responsible for supporting cGMP mRNA drug substances and sterile drug product produced internally at Moderna. This individual will demonstrate dynamic range with the capability to provide quality oversight of the manufacturing operations, technology transfer projects, or other GMP facility aspects and automated systems. The successful candidate will have experience in quality oversight or manufacturing experience in commercial products.

Here’s What You’ll Do:

• Provide Quality oversight for commissioning, qualification, and validation initiatives including complex GMP facility and automated system projects

• Provide Quality oversight of product Technology Transfers

• Provide Quality oversight of significant deviations, including root cause analysis records, and change controls

• Review protocols, risk assessments, facility changes, and / or control strategies

• Writes, reviews, and approves GMP documentation. (SOPs, Forms, Technical Reports, Specifications, etc.)

• Participate in Internal and External Audits, including Health Authority inspections

• Collaborate cross-functionally to enable Quality Culture and a continuous improvement mindset

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

• Bachelor’s Degree in a science field (e.g., Engineering, Chemistry) or equivalent combination of education and experience

• 8+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices

• Demonstrated ability making risk based decisions

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to well-being
• Free premium access to fitness, nutrition, and mindfulness classes
• Family planning and adoption benefits
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
• Educational resources
• Savings and investments
• 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, theinfrastructure 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 employment opportunity 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 also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations 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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