Sr. Scientist, Analytical Development

The Role

In this role you will serve as the Analytical Program Lead (APL) for a family of programs accountable for all analytical activities required to support regulatory filings (e.g. IND and BLA/MAA) and early post-approval lifecycle activities. You will lead the definition and execution of program-level analytical strategies to enable successful clinical introduction licensure. and transition to commercial manufacturing.

You will be responsible for driving analytical readiness for clinical and registrational stage programs including specification setting analytical control strategy development and comparability strategy design and execution (e.g. process changes site transfers lifecycle evolution) as well as generation of robust data packages to support global submissions. This role requires strong cross-functional leadership and the ability to ensure alignment across development manufacturing quality and regulatory teams.

This is an individual contributor role focused on program delivery scientific rigor and regulatory excellence. The role also plays an integral part in authoring and reviewing regulatory sections and responding to RTQs across programs.

Heres What Youll Do

• Serve as the Analytical Program Lead for a family of programs accountable for all analytical activities required to support regulatory filings (e.g. IND and BLA/MAA) and early lifecycle submissions.
• Define and execute integrated analytical strategies including specifications analytical control strategy comparability (process changes site transfers lifecycle) and assay lifecycle management.
• Establish commercial specifications control strategies and comparability frameworks to enable initial licensure and post-approval changes.
• Ensure analytical readiness for clinical studies and commercial manufacturing including method qualification/validation transfer and control strategy implementation.
• Lead and author analytical sections of regulatory filings (e.g. IND and BLA/MAA) and responses to health authority questions/RTQs ensuring clarity consistency and regulatory defensibility.
• Partner cross-functionally (QC Regulatory CMC MS&T Manufacturing) to deliver robust compliant and inspection-ready analytical data packages.
• Identify and mitigate analytical risks including defining acceptance criteria and justification strategies aligned with global regulatory expectations.
• Mentor team members and contribute to consistent high-quality execution across programs.
• Additional duties may be assigned from time to time.

Heres What Youll Bring to the Table (Basic Qualifications)

• Ph.D. in Analytical Chemistry Biochemistry Pharmaceutical Sciences or related field with 5 years of relevant industry experience or M.S./B.S. with 8 years of experience in analytical development or quality control of biologics or vaccines.

Heres What Youll Bring to the Table (Preferred Qualifications)

• Experience in analytical development for biologics or nucleic acid-based therapeutics including experience with comparability strategy study design and regulatory justification.
• Understanding of analytical control strategy specification setting and method lifecycle management for initial licensure.
• Demonstrated experience authoring and reviewing analytical and CMC sections of BLAs/MAAs and responding to health authority queries.
• Knowledge of ICH guidelines GMP and global regulatory expectations for late-phase development and commercial readiness.
• Proven ability to translate complex analytical data into clear concise and defensible regulatory narratives.
• Experience supporting technology transfer method validation and commercial site readiness.
• Cross-functional collaboration skills with Regulatory Quality MS&T and Manufacturing.
• Ability to operate effectively in a fast-paced matrixed environment with a high degree of accountability.
• A desire to make an impact as part of a high-growth transformational company that is Bold Relentless Curious and Collaborative.

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. Thats why our benefits and well-being resources are designed to support youat 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 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 investments to help you plan for the future
• Location-specific perks and extras

The salary range for this role is $130800.00 - $209400.00. 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 individuals 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 to learn more about our current opportunities.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons 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 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

Were 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 .

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 applicants 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.

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