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The Role:
In this role, you will primarily focus on managing the analytical control strategy to support large-scale process development and optimization for plasmid DNA, cell-free DNA and enzymes. Responsibilities include driving analytical control strategies and associated deliverables, such as test method development, optimization, pre-qualification, qualification, and validation; specification setting; and the timely initiation of IPC, release, characterization testing and stability studies. The role will also support investigations related to release and stability data. You are expected to work in a highly collaborative, cross-functional team environment, and interface with different departments as well as technical and operational teams. The individual must thrive in a fast-paced environment with high expectations. Integrity, ability to pay attention to detail and troubleshoot, curiosity, collaborative spirit, respect for people, exemplary work ethic and setting the bar high are key values to thrive in this team.

This role is located at the Moderna Technology Center in Norwood, MA.

Here's What You'll Do:

• Partner closely with the Analytical Program Lead for DNA and Enzymes to drive analytical control strategies that support large-scale process development and optimization for plasmid DNA, cell-free DNA, and enzymes.

• Develop and maintain tracking systems to monitor analytical deliverables, including test method development, optimization, pre-qualification, qualification, and validation; specification setting; and timely initiation of IPC, release, characterization testing, and stability studies.

• Collaborate with cross-functional stakeholders to ensure timely procurement and availability of analytical testing materials

• Support investigations of out-of-specification (OOS) and out-of-trend (OOT) results in collaboration with Analytical Development SMEs, Analytical Technical Operations, and Quality, as needed.

• Generate high-quality technical documentation to support regulatory submissions and internal communications.

• Serve as a subject matter expert in analytical control strategies for DNA and enzymes, supporting cross-functional teams including Analytical Development, Process Development, Manufacturing, Quality, Supply Chain, and CMC Regulatory.

Here's What You'll Need (Basic Qualifications)

• MS with 5 years or BS with 8 years of biotech or pharmaceutical industry experience in analytical development.

• Strong background in chromatographic separation, biophysical characterization, and spectrophotometric techniques, equipment platforms (e.g. Thermo, Waters, Agilent), and data processing software (e.g. Chromeleon, ChemStation, Empower)

• (Preferred) Understanding of critical quality attributes and analytical test methods for biologics including plasmid DNA, proteins, enzymes, mRNA and lipid nanoparticles

• (Preferred) Experience with method development and qualification

• (Preferred) Experience with program or project management

• Knowledge of industry standards and current FDA and ICH guidelines

• Excellent written and oral communication skills; strong organizational skills and attention to detail

• (Preferred) Familiarity with electronic notebooks, LES, LIMS and Veeva quality management system

• Ability to work independently and as part of a team, self-motivation, adaptable, and a positive attitude.

• Ability to prioritize work and experience in managing multiple projects 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.

• At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.

Pay & Benefits

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

• Best-in-class healthcare coverage, 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 planning benefits, including fertility, adoption, and surrogacy support

• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown

• Savings and investment opportunities to help you plan for the future

• Location-specific perks and extras

The salary range for this role is $89,900.00 - $143,800.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

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.

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.

Our Working Model

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.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Equal Opportunities

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.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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

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 accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation 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 team at leavesandaccommodations@modernatx.com.

Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-TR2

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