BioSpace
Senior Manager, Analytical Science & Technology (AS&T)
BioSpace, Norwood, Massachusetts, us, 02062
Senior Manager, Analytical Science & Technology (AS&T)
Moderna is seeking a Senior Manager – Analytical Sciences & Technology (AS&T) – CMC based at their Norwood, MA site. The role provides technical expertise and program support for analytical method related activities that support late‑phase development and commercial programs. The Senior Manager, AS&T – CMC Lead will oversee qualification, validation, transfer, and lifecycle strategies for analytical methods across a global network. The ideal candidate has a strong background in regulatory submissions, analytical sciences, and method validation, with proven experience in late‑stage and commercial product support.
Responsibilities
Late‑Phase & Commercial Program Strategy
Lead the design and execution of analytical qualification and validation strategies for late‑phase and commercial programs, ensuring alignment with regulatory expectations and industry best practices.
Method Transfer Leadership
Contribute to method transfer strategies in collaboration with internal and external partners across the Norwood site and other testing locations, ensuring consistency, compliance, and readiness for commercial supply.
Validation Master Plan Ownership
Author, maintain, and oversee Validation Master Plans, ensuring they reflect program needs, compliance requirements, and product lifecycle considerations.
Analytical Method Lifecycle Management
Define and manage commercial method lifecycle strategy, including distribution, governance, and continuous improvement across the manufacturing network.
Regulatory Submission Support
Support the preparation of analytical sections for regulatory filings related to late‑phase and commercial programs to support product approvals and lifecycle maintenance.
Regulatory Commitments & Queries
Lead the preparation and execution of responses to regulatory queries (RtQ) and post‑approval commitments, ensuring timely, clear, and compliant communication with global health authorities.
Basic Qualifications
Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field
8+ years of experience in Analytical Development, Quality Control, or related functions within the biopharmaceutical industry
Strong expertise in analytical method qualification, validation, and lifecycle management in late‑phase and commercial settings
Proven experience with regulatory submissions (BLA, MAA, etc.) and direct interactions with global health authorities
In‑depth knowledge of ICH guidelines, GMP regulations, and industry best practices
Excellent technical writing skills and ability to author high‑quality regulatory documentation
Strong collaboration, communication, and influencing skills across cross‑functional and global teams
This position is site‑based, requiring full‑time presence at Moderna’s site; remote work is not eligible
Preferred Qualifications
Advanced degree (M.S., Ph.D.) in a scientific discipline
Experience supporting biologics, vaccines, or other complex modalities
Prior experience in global method transfers and managing a network of manufacturing/testing sites
Work Environment & Expectations
Individual contributor position with high visibility and strategic impact
Cross‑functional engagement with Regulatory Affairs, Quality Control, Manufacturing, and Technical Operations
Some domestic and international travel may be required to support site transfers and regulatory engagements
Pay & Benefits Salary range: $130,800.00 – $209,400.00. The final compensation will be based on qualifications, experience, and business needs.
Best‑in‑class healthcare coverage and voluntary benefit programs
Well‑being resources—including fitness, mindfulness, and mental health support
Family planning benefits (fertility, adoption, surrogacy support)
Generous paid time off, vacation, volunteer days, sabbatical, global recharge days, and discretionary year‑end shutdown
Savings and investment opportunities for future planning
Location‑specific perks and extras
About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform and the infrastructure to reimagine how medicines are created and delivered. 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.
Equal Opportunities Moderna is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to race, color, sex, gender identity, age, religion, national origin, ancestry, citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status or any other protected characteristic under applicable law.
Accommodations We are committed to offering reasonable accommodations to qualified job applicants with disabilities. For accommodation requests, please 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. Employment is contingent upon the applicant’s ability to access export‑controlled information in accordance with U.S. law. Only U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible; non‑U.S. persons will not be sponsored for an export control license.
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Responsibilities
Late‑Phase & Commercial Program Strategy
Lead the design and execution of analytical qualification and validation strategies for late‑phase and commercial programs, ensuring alignment with regulatory expectations and industry best practices.
Method Transfer Leadership
Contribute to method transfer strategies in collaboration with internal and external partners across the Norwood site and other testing locations, ensuring consistency, compliance, and readiness for commercial supply.
Validation Master Plan Ownership
Author, maintain, and oversee Validation Master Plans, ensuring they reflect program needs, compliance requirements, and product lifecycle considerations.
Analytical Method Lifecycle Management
Define and manage commercial method lifecycle strategy, including distribution, governance, and continuous improvement across the manufacturing network.
Regulatory Submission Support
Support the preparation of analytical sections for regulatory filings related to late‑phase and commercial programs to support product approvals and lifecycle maintenance.
Regulatory Commitments & Queries
Lead the preparation and execution of responses to regulatory queries (RtQ) and post‑approval commitments, ensuring timely, clear, and compliant communication with global health authorities.
Basic Qualifications
Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field
8+ years of experience in Analytical Development, Quality Control, or related functions within the biopharmaceutical industry
Strong expertise in analytical method qualification, validation, and lifecycle management in late‑phase and commercial settings
Proven experience with regulatory submissions (BLA, MAA, etc.) and direct interactions with global health authorities
In‑depth knowledge of ICH guidelines, GMP regulations, and industry best practices
Excellent technical writing skills and ability to author high‑quality regulatory documentation
Strong collaboration, communication, and influencing skills across cross‑functional and global teams
This position is site‑based, requiring full‑time presence at Moderna’s site; remote work is not eligible
Preferred Qualifications
Advanced degree (M.S., Ph.D.) in a scientific discipline
Experience supporting biologics, vaccines, or other complex modalities
Prior experience in global method transfers and managing a network of manufacturing/testing sites
Work Environment & Expectations
Individual contributor position with high visibility and strategic impact
Cross‑functional engagement with Regulatory Affairs, Quality Control, Manufacturing, and Technical Operations
Some domestic and international travel may be required to support site transfers and regulatory engagements
Pay & Benefits Salary range: $130,800.00 – $209,400.00. The final compensation will be based on qualifications, experience, and business needs.
Best‑in‑class healthcare coverage and voluntary benefit programs
Well‑being resources—including fitness, mindfulness, and mental health support
Family planning benefits (fertility, adoption, surrogacy support)
Generous paid time off, vacation, volunteer days, sabbatical, global recharge days, and discretionary year‑end shutdown
Savings and investment opportunities for future planning
Location‑specific perks and extras
About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform and the infrastructure to reimagine how medicines are created and delivered. 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.
Equal Opportunities Moderna is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to race, color, sex, gender identity, age, religion, national origin, ancestry, citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status or any other protected characteristic under applicable law.
Accommodations We are committed to offering reasonable accommodations to qualified job applicants with disabilities. For accommodation requests, please 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. Employment is contingent upon the applicant’s ability to access export‑controlled information in accordance with U.S. law. Only U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible; non‑U.S. persons will not be sponsored for an export control license.
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