Scientist, Analytical Development

Moderna Therapeutics; Norwood (MA); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Fertility/adoption support

Generous paid time off

Discretionary bonus eligibility

Job summary

Moderna Therapeutics in the United States seeks an Analytical Sciences transfer lead to drive method moves from development into ATO and QC laboratories. You will oversee readiness assessments, strategy design, and cross-site collaboration to ensure robust transfers and rapid issue resolution.

The role demands advanced degree with extensive hands-on experience in analytical method transfer, GMP environments, and strong troubleshooting capabilities to support high-stakes clinical development

Qualifications

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering or a related field with 2+ years of industry experience, or M.S. with 8+ years, or B.S./B.A. with 12+ years in analytical development or related functions.
• Experience leading analytical method transfers into GMP or GMP-supporting laboratories across multiple methods, products, or sites.
• Familiarity with ICH Q2(R2), ICH Q14, USP <1224>, data integrity, and lifecycle principles.

Responsibilities

• Serve as the Analytical Sciences transfer lead for methods moving from Development into ATO and QC labs.
• Perform readiness assessments using data, robustness, risks, system suitability, and reference standards.
• Define phase-appropriate transfer strategies, criteria, and study designs reflecting product use and risk.
• Lead troubleshooting and root-cause investigations during transfer and early routine use.
• Prepare complete transfer packages with rationale, critical steps, and troubleshooting guidance.

Skills

Method transfer leadership

GMP experience

ICH Q2(R2) knowledge

Analytical method development

Root-cause investigations

Education

Ph.D. in Analytical Chemistry/related

M.S. in Analytical Chemistry/related

B.S./B.A. in Analytical Chemistry/related

Job description

Here’s What You’ll Do

Serve as the Analytical Sciences technical transfer lead for assigned analytical methods moving from Analytical Development into ATO and QC laboratories, driving transfer activities from readiness assessment through execution, troubleshooting, and transfer closeout.

Perform rigorous method-transfer readiness assessments using development and qualification data, robustness knowledge, method risk assessments, critical method parameters, system suitability, assay controls, reference standards, critical reagents, sample preparation, data processing, and known method limitations.

Define and execute phase-appropriate transfer strategies, protocols, acceptance criteria, and study designs that reflect the method’s intended use, product-development phase, scientific maturity, and patient/product risk.

Partner with method-development scientists before formal handoff to improve transferability, including strengthening method robustness, operational ranges, procedural clarity, system suitability and assay controls, critical-material controls, and troubleshooting guidance.

Apply strong hands‑on laboratory expertise during method transfer as needed to reproduce methods, train receiving-laboratory analysts, evaluate analyst/instrument/site effects, and rapidly resolve technical barriers to successful execution.

Lead scientific troubleshooting and root‑cause investigations during transfer and early routine use, designing targeted experiments to distinguish method, sample, reagent, instrument, software, analyst, and laboratory‑environment sources of variability and implementing durable corrective actions.

Ensure development knowledge is translated into complete and usable transfer packages, including scientific rationale, critical steps and parameters, method failure modes, material and reagent requirements, expected performance, data‑analysis conventions, and practical troubleshooting guidance.

Partner with AST, QC, Quality, ATO, and Regulatory to align method qualification, validation, verification, and transfer expectations with ICH Q2(R2), ICH Q14, USP <1224>, applicable GMP requirements, and phase‑appropriate principles for clinical development.

Provide scientific support for deviations, OOS/OOT investigations, change controls, CAPAs, and post‑transfer stabilization when method performance or execution issues arise, ensuring that troubleshooting remains grounded in method‑development knowledge and scientific rationale.

Build and improve standardized transfer playbooks, templates, readiness criteria, and best practices across method families, helping establish consistent expectations for transfers into clinical and commercial testing laboratories.

Monitor transfer outcomes and early method‑performance trends, capture lessons learned, and feed findings back to Analytical Development and Analytical Sciences to drive continual method improvement, platform harmonization, and stronger future method designs.

Author and review transfer protocols and reports, analytical procedures, risk assessments, technical summaries, training materials, change‑control documentation, and regulatory‑supporting content with a high standard of scientific rigor and data integrity.

Here’s What You’ll Need (Basic Qualifications)

Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field with 2+ years of relevant industry experience, or M.S. with 8+ years, or B.S./B.A. with 12+ years of relevant experience in analytical development, analytical sciences, Quality Control, or related pharmaceutical development functions.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

Strong hands‑on analytical method development experience, with demonstrated ability to optimize methods, establish robustness, understand method failure modes, and translate scientific knowledge into reliable routine procedures.

Direct experience executing multiple analytical method transfers into GMP or GMP‑supporting laboratories, with strong preference for candidates who have led transfers across different methods, products, laboratories, or sites.

Demonstrated expertise troubleshooting difficult analytical method‑performance issues during transfer or routine testing and designing scientifically sound experiments to identify root causes and implement sustainable solutions.

Strong working knowledge of analytical procedure development, qualification, validation, verification, and lifecycle principles, including ICH Q2(R2), ICH Q14, USP <1224>, quality risk management, and data‑integrity expectations.

Solid understanding of phase‑appropriate GMP principles and the ability to apply an appropriate level of analytical rigor, documentation, controls, and validation based on clinical phase, intended use, method maturity, and risk.

Scientific depth in one or more major analytical technology areas such as chromatography/separation science, electrophoresis, spectroscopy, compendial testing, molecular methods, bioassays, or other analytical platforms relevant to biologics, vaccines, nucleic acids, or advanced modalities.

Experience assessing laboratory‑to‑laboratory differences in instrumentation, software, reagents, reference standards, sample preparation, environmental conditions, and analyst technique and determining appropriate bridging or mitigation strategies.

Strong understanding of system suitability, assay controls, critical reagents and materials, reference‑standard strategy, statistical assessment of method performance, and the relationship between method robustness and successful transfer.

Experience supporting deviations, OOS/OOT investigations, change controls, CAPAs, method remediation, or lifecycle changes in a regulated analytical environment.

Experience working across Analytical Development, QC, Quality, Regulatory, AS&T/MST&T, and/or external testing laboratories, with the ability to translate development science into practical expectations for routine laboratory execution.

Experience with mRNA, LNP, vaccines, biologics, or other advanced therapeutic modalities is preferred.

Excellent technical writing, communication, collaboration, and stakeholder‑management skills, with the ability to explain complex analytical issues clearly, influence cross‑functional decisions, and maintain scientific rigor in a fast‑moving environment.

Self‑motivated, highly collaborative, and comfortable combining hands‑on technical work with cross‑functional leadership, with a desire to make an impact as part of a company that is Bold, Relentless, Curious, and Collaborative.

Our Working Model

As we build our company, we have always believed that an in‑person culture is critical to our success. This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to our site‑based operations. Working onsite enables real‑time collaboration, strong team connections, direct mentorship, and the hands‑on partnership needed to deliver our mission.

Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

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

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.

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, 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 [e-mail].

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.

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 relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay any 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 [e-mail] 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.