Scientist, Analytical Sciences and Technology
RXinsider LTD.
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Benefits offered by this job
Job summary
Moderna is seeking an experienced analytical chemistry leader to drive method transfer, validation, troubleshooting, and lifecycle management across internal and external labs. You will collaborate with QC, QA, regulatory, and CMOs to ensure compliant, robust analytical performance.
The role emphasizes data-driven decision making, investigations of OOS/OOT results, and development of CAPAs to improve processes and product quality across commercial and late-stage programs.
Qualifications
- Bachelor's degree with 5+ years in GMP regulated environments or higher degrees with corresponding experience.
- Experience supporting analytical method transfer, qualification, validation, verification, or lifecycle management.
- Experience authoring and reviewing technical documents and SOPs.
Responsibilities
- Lead method transfers, validations, verifications, and comparability assessments across labs.
- Provide technical expertise for method performance monitoring and lifecycle management.
- Collaborate cross-functionally to ensure robust analytical performance and compliance.
- Support investigations, OOS/OOT assessments, and CAPA development.
- Author, review, and approve protocols, reports, specifications, and SOPs.
- Provide technical oversight for external partners and CMOs.
Skills
Education
Tools
Job description
Moderna is seeking an Individual that will provide technical leadership and execution support for analytical method lifecycle management across commercial and late-stage development programs. This role will be responsible for method transfer, validation, troubleshooting, investigations, and continuous improvement activities supporting Quality Control laboratories, manufacturing operations, and external testing partners. The Candidate will serve as a key technical resource across the analytical network, collaborating with Quality Control, Quality Assurance, Regulatory Affairs, Manufacturing Sciences, and Contract Manufacturing Organizations (CMOs) to ensure robust analytical performance, compliance, and inspection readiness. The successful candidate will leverage scientific expertise to support product lifecycle management, drive technical solutions, and ensure reliable execution of analytical testing strategies.
- Lead and support analytical method transfers, validations, verifications, and comparability assessments across internal and external laboratories.
- Provide technical expertise for method performance monitoring and lifecycle management activities.
- Evaluate analytical method suitability and identify opportunities for continuous improvement.
- Serve as a subject matter expert for analytical methods and testing processes.
- Support troubleshooting of analytical issues impacting laboratory operations, manufacturing, and product disposition.
- Collaborate cross-functionally to identify root causes and implement effective corrective actions.
- Support laboratory investigations, out-of-specification (OOS), out-of-trend (OOT), and atypical result assessments.
- Perform scientific data analysis to identify trends, risks, and opportunities for process improvement.
- Contribute to development and implementation of CAPAs to address analytical and operational issues.
- Author, review, and approve technical documents including protocols, reports, methods, specifications, and standard operating procedures (SOPs).
- Ensure documentation is accurate, compliant, and inspection-ready.
- Support regulatory submissions, health authority inspections, and internal audits as required.
- Collaborate with QC laboratories and external testing partners to ensure successful method implementation and execution.
- Provide technical oversight and support for analytical activities conducted at CMOs and contract testing laboratories.
- Support network harmonization efforts and best-practice sharing across sites.
- Analyze analytical performance metrics and trending data to drive informed decision-making.
- Support development and implementation of process improvements that enhance efficiency, compliance, and robustness.
- Contribute to digital and data-driven initiatives supporting analytical operations.
- Bachelor's degree in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline with 5+ years of relevant industry experience; OR
- Master's degree in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline with 3+ years of relevant industry experience; OR
- PhD in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline with 0-2 years of relevant industry experience.
- Experience supporting analytical method transfer, qualification, validation, verification, or lifecycle management activities in a GMP-regulated pharmaceutical, biotechnology, biologics, or vaccine environment.
- Experience authoring and reviewing technical documents, including protocols, reports, specifications, test methods, investigations, and standard operating procedures (SOPs).
- Working knowledge of GMP regulations, data integrity principles, and pharmaceutical quality systems.
- Experience supporting laboratory investigations, including out-of-specification (OOS), out-of-trend (OOT), deviation, or atypical result assessments.
- Demonstrated ability to analyze scientific data, identify trends, and apply scientific judgment to solve technical problems.
- Experience working effectively in cross-functional teams with Quality Control, Quality Assurance, Manufacturing, Regulatory Affairs, and/or external partners.
- Strong understanding of analytical method validation, transfer, qualification, verification, and lifecycle management principles, including application of risk-based and phase-appropriate strategies.
- Hands-on experience with chromatographic, spectroscopic, molecular, lipid-based, vaccine, biologics, or biochemical analytical techniques.
- Knowledge of applicable regulatory and compendial expectations, including ICH, USP, FDA, EMA, and other global health authority requirements.
- Experience leading or substantially contributing to investigations, CAPAs, deviation management, change controls, or analytical troubleshooting activities.
- Experience working with external manufacturing organizations, contract testing laboratories, or other third-party testing partners.
- Experience supporting analytical control strategies, method readiness, product lifecycle changes, or regulatory filing activities.
- Ability to communicate complex technical topics clearly to cross-functional stakeholders, including Quality, Manufacturing, Regulatory, Technical Development, and senior leadership audiences.
- Demonstrated ability to operate effectively in a matrixed, fast-paced, and evolving technical environment.
- Scientific problem solving and critical thinking
- Technical leadership and collaboration
- Strong data analysis and interpretation skills
- Effective communication and stakeholder management
- Attention to detail and commitment to quality
- Ability to manage multiple priorities in a fast-paced environment
At Moderna, we believe that when you feel your best, you can do your best work.
That's why our benefits and well-being resources are designed to support you - at 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 $109,200.00 - $174,600.00. 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.
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.
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.
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.
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.
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