What are the responsibilities and job description for the Scientist, Analytical Development position at BioSpace?
The Role
Moderna is seeking a Scientist / Manager for our Norwood, MA Technology Center to lead the Reference Standard strategy and lifecycle management that underpins analytical activities for our mRNA programs. Partnering with technical and operations teams across Analytical Development, Analytical Tech Operations, Quality Control, Analytical Science & Technology, Process Development, Manufacturing, and Regulatory Affairs, this position will design and execute the acquisition, qualification, re-qualification, change-control, and phase-transition plans that keep RNA, lipid nanoparticle, and drug-product reference standards fit-for-purpose throughout clinical development. Reporting to the Director of Analytical Science, this person will oversee aliquoting, inventory, distribution, and shipments with end-to-end traceability; mine and trend analytical data to inform decisions; author protocols and regulatory submissions; and champion a culture of safety, data integrity, and cross-functional collaboration.
Here’s What You’ll Do
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.
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.
Moderna is seeking a Scientist / Manager for our Norwood, MA Technology Center to lead the Reference Standard strategy and lifecycle management that underpins analytical activities for our mRNA programs. Partnering with technical and operations teams across Analytical Development, Analytical Tech Operations, Quality Control, Analytical Science & Technology, Process Development, Manufacturing, and Regulatory Affairs, this position will design and execute the acquisition, qualification, re-qualification, change-control, and phase-transition plans that keep RNA, lipid nanoparticle, and drug-product reference standards fit-for-purpose throughout clinical development. Reporting to the Director of Analytical Science, this person will oversee aliquoting, inventory, distribution, and shipments with end-to-end traceability; mine and trend analytical data to inform decisions; author protocols and regulatory submissions; and champion a culture of safety, data integrity, and cross-functional collaboration.
Here’s What You’ll Do
- Lead the end-to-end Analytical Reference Standard strategy for RNA, lipid nanoparticle and drug product for mRNA programs in clinical development.
- Work closely with colleagues within Analytical Development, Process Development, Analytical Tech Operations, Analytical Sciences and Technology and Quality Control teams to manage Reference Standard lifecycle activities (acquisition, qualification, requalification/stability, phase transition change/bridging), and drive timelines using project management tools.
- Review, track and assess Reference Standard data, and document and communicate findings.
- Oversee all logistic for Reference Standard, such as aliquoting, storage, inventory, distribution, shipping, and disposal activities to ensure full compliance ad traceability.
- Demonstrate independent scientific judgment to study design, data interpretation, technical protocols and reports, regulatory filings, and responses to agency queries; Clearly present findings to multidisciplinary teams.
- Maintain a safe laboratory work environment and be accountable for good documentation practices.
- B.S. with 5-10 years or MS with 3-5 years of relevant industry experience in analytical development, or quality control, or closely related field. GMP analytical-chemistry experience is preferred.
- Proven ability to manage projects of significant scope and complexity, while meeting all deliverables and timelines.
- Hand-on experience in data analysis and statistical evaluation.
- Hand-on experience in analytical method development and analytical reference standard.
- Experience in documentation and authoring regulatory submission documents in pharmaceutical or biotech industries
- Exceptional organizational, communication, and critical thinking skills, and the ability to thrive in an interdependent and idea-rich environment.
- Excellent interpersonal and collaborative skills.
- Ability to navigate through ambiguity and rapid growth and adapt to change.
- Previous hands-on industry experience with analytical development for nanoparticles, RNA, therapeutics, or biologics is a plus and preferred
- 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 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 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.
Salary : $109,200 - $174,600