Scientist, Analytical Sciences and Technology at Moderna

Norwood, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

03 Oct, 26

Salary

174600.0

Posted On

05 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical Method Lifecycle Management, Method Validation, Method Transfer, GMP Compliance, Troubleshooting, OOS/OOT Investigations, CAPA Implementation, Technical Writing, Data Analysis, Cross-functional Collaboration, Regulatory Submissions, CMO Management, Chromatography, Spectroscopy, Molecular Analysis, Biochemical Techniques

Industry

Biotechnology Research

Description

The Role 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. Here's What You’ll Do 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. Technical Support & Troubleshooting 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. Investigations & Data Review 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. Documentation & Compliance 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. QC Network & External Partner Support 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. Data Trending & Continuous Improvement 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. Here’s What You’ll Need (Basic Qualifications) 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. Here’s What You’ll Bring to the Table (Preferred Qualifications) 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. Competency 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 Pay & Benefits 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. 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. #LI-SB2 - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home

Responsibilities

Provide technical leadership for analytical method lifecycle management, including transfer, validation, and troubleshooting across commercial and late-stage programs. Collaborate with QC, QA, and external partners to ensure compliance, inspection readiness, and robust analytical performance.