What are the responsibilities and job description for the Sr. Manager, CMC Stability position at BioSpace?
The Role
Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.
Moderna is strengthening its presence in Norwood, Massachusetts, a cornerstone of our manufacturing and operational excellence. Our Norwood campus translates mRNA science into scalable impact, supporting the global delivery of our medicines. We welcome talent ready to drive innovation and make a meaningful difference for patients worldwide.
As a stability leader, you will execute phase-appropriate stability strategies across a diverse portfolio of mRNA programs spanning development, clinical, and commercial stages.
You will act as a program-facing scientific expert, translating stability data into actionable insights that inform regulatory, supply, and lifecycle decisions.
Operating as an individual contributor, you will combine scientific rigor, operational execution, and cross-functional collaboration to ensure robust product control strategies and uninterrupted patient supply.
Here’s What You’ll Do
Define and execute stability strategies for assigned development, clinical, or commercial programs, ensuring alignment with program goals, regulatory expectations, and business needs.
Design stability protocols and study plans to support clinical progression, registration activities, commercial maintenance, and lifecycle management initiatives as applicable.
Review and interpret stability data, perform trending analyses, and support statistical evaluations to identify product trends, risks, and opportunities.
Generate and communicate recommendations for shelf-life assignment, expiry updates, storage conditions, and stability risk mitigation based on available data.
Support stability-related input into formulation, process development, control strategy, and change-management discussions.
Author and contribute to stability sections for regulatory submissions, responses, and technical documentation across clinical, registration, and post-approval stages.
Partner with Clinical Supply, Supply Chain, and cross-functional stakeholders to manage stability milestones, inventory risk, and expiry-related planning.
Lead or support investigations for stability-related OOS/OOT events, working closely with Quality to ensure timely and compliant resolution.
Maintain high standards of data integrity, documentation quality, and inspection readiness for all stability-related deliverables.
Collaborate across Analytical Development, Quantitative Sciences, Process Development, Quality, Regulatory, Clinical Supply, Supply Chain, and Commercial teams to align study execution and decision-making with broader program priorities.
Identify and implement opportunities to improve stability processes, tracking, reporting, and overall team effectiveness.
Leverage digital tools and advanced analytics, including exposure to emerging generative AI capabilities, to enhance data interpretation and decision-making.
Perform additional duties as required to support evolving portfolio and business needs.
The key Moderna Mindsets you’ll need to succeed in the role:
“We act with dynamic range, driving strategy and execution at the same time at every step.”
“We obsess over learning. We don’t have to be the smartest we have to learn the fastest.”
Here’s What You’ll Bring to the Table (Basic Qualifications)
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.
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.
Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.
Moderna is strengthening its presence in Norwood, Massachusetts, a cornerstone of our manufacturing and operational excellence. Our Norwood campus translates mRNA science into scalable impact, supporting the global delivery of our medicines. We welcome talent ready to drive innovation and make a meaningful difference for patients worldwide.
As a stability leader, you will execute phase-appropriate stability strategies across a diverse portfolio of mRNA programs spanning development, clinical, and commercial stages.
You will act as a program-facing scientific expert, translating stability data into actionable insights that inform regulatory, supply, and lifecycle decisions.
Operating as an individual contributor, you will combine scientific rigor, operational execution, and cross-functional collaboration to ensure robust product control strategies and uninterrupted patient supply.
Here’s What You’ll Do
Define and execute stability strategies for assigned development, clinical, or commercial programs, ensuring alignment with program goals, regulatory expectations, and business needs.
Design stability protocols and study plans to support clinical progression, registration activities, commercial maintenance, and lifecycle management initiatives as applicable.
Review and interpret stability data, perform trending analyses, and support statistical evaluations to identify product trends, risks, and opportunities.
Generate and communicate recommendations for shelf-life assignment, expiry updates, storage conditions, and stability risk mitigation based on available data.
Support stability-related input into formulation, process development, control strategy, and change-management discussions.
Author and contribute to stability sections for regulatory submissions, responses, and technical documentation across clinical, registration, and post-approval stages.
Partner with Clinical Supply, Supply Chain, and cross-functional stakeholders to manage stability milestones, inventory risk, and expiry-related planning.
Lead or support investigations for stability-related OOS/OOT events, working closely with Quality to ensure timely and compliant resolution.
Maintain high standards of data integrity, documentation quality, and inspection readiness for all stability-related deliverables.
Collaborate across Analytical Development, Quantitative Sciences, Process Development, Quality, Regulatory, Clinical Supply, Supply Chain, and Commercial teams to align study execution and decision-making with broader program priorities.
Identify and implement opportunities to improve stability processes, tracking, reporting, and overall team effectiveness.
Leverage digital tools and advanced analytics, including exposure to emerging generative AI capabilities, to enhance data interpretation and decision-making.
Perform additional duties as required to support evolving portfolio and business needs.
The key Moderna Mindsets you’ll need to succeed in the role:
“We act with dynamic range, driving strategy and execution at the same time at every step.”
“We obsess over learning. We don’t have to be the smartest we have to learn the fastest.”
Here’s What You’ll Bring to the Table (Basic Qualifications)
- Education: Degree in Life Sciences, Chemistry, Engineering, Pharmaceutical Sciences, or related technical discipline
- Experience: 10 years of relevant experience with Bachelor’s degree or 2 years of relevant experience with a PhD.
- This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.
- Advanced degree in a relevant field is preferred combined with a 4 years of relevant industry experience
- Experience supporting stability programs for biologics, vaccines, or other complex drug products in either development/clinical or commercial settings.
- Experience authoring or contributing to stability sections for regulatory submissions and responses.
- Strong background in stability data interpretation, statistical analysis, and shelf-life assessment.
- Experience working in cross-functional CMC teams within a matrixed development or commercial environment.
- Familiarity with ICH stability guidance and global regulatory expectations related to expiry dating, storage conditions, and post-approval commitments.
- Experience supporting stability-related investigations, risk assessments, and change evaluations.
- Ability to communicate clearly, influence constructively, and manage multiple priorities in a fast-paced environment.
- Strong organizational skills and a demonstrated ability to drive execution with a high degree of accountability.
- Experience with development and clinical programs, or with commercial lifecycle management, annual product quality review support, or expiry-risk management, is preferred.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
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
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.
Salary : $130,800 - $209,400