Director, Analytical Technical Operations

ModernaTX, Inc.; Norwood (MA); On-site; USD 167,000 - 301,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being programs

Family planning benefits

Generous paid time off

Savings and investments

Job summary

Moderna Therapeutics Inc. in Norwood, MA is seeking a senior leader to head the Core Analytical Testing & Integrations organization. You will guide a 30–50 person team responsible for generating high-quality analytical data for CMC development and Module 3 regulatory submissions.

The role focuses on non-GMP release, stability, and a subset of GMP testing in partnership with QC. You will align strategy with development, manufacturing and quality teams, drive digital workflows, and modernize tools

Qualifications

• Degree in Analytical Chemistry, Chemistry, Biochemistry, Molecular Biology, Pharmaceutical Sciences, Life Sciences, Engineering, or related technical discipline.
• 15 years of relevant industry experience with a Bachelor's or 10 years with a PhD in analytical development, analytical testing, technical operations, Quality Control, or related CMC lab functions.
• PhD in a relevant scientific or engineering discipline is preferred.

Responsibilities

• Lead the Core Analytical Testing & Integrations organization, setting strategy, capacity plans and execution standards.
• Oversee non-GMP analytical testing supporting end-to-end process development and non-GMP release.
• Ensure complete, accurate, traceable development analytical data for regulatory submissions.

Skills

Analytical chemistry

People leadership

Regulatory submissions

Data integrity

Education

Analytical Chemistry degree

PhD preferred

Job description

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. You will lead Moderna’s Core Analytical Testing & Integrations organization, an approximately 30–50-person team responsible for generating controlled, reproducible and filing-ready analytical data that underpin CMC development and Module 3 (Quality) regulatory submissions. Operating primarily in a non-GMP environment, you will bring together deep technical leadership across separations, RNA and lipid analytics, biophysical and compendial methods, molecular biology, sequencing and microbiology, while overseeing non-GMP release, stability, engineering-run and PPQ-related development support and a limited portfolio of phase-appropriate GMP testing in partnership with QC. You will shape the next evolution of the function by protecting rigorous scientific execution and submission-critical data quality while improving laboratory efficiency, method-performance insight, digital workflows and the connection between development analytical methods and GMP QC operations.

Here’s What You’ll Do

Lead the Core Analytical Testing & Integrations organization, setting strategy, capacity plans, execution standards and continuous-improvement priorities while safeguarding existing program commitments.

Lead approximately 30–50 scientists, analysts, managers and integration specialists across separations and RNA/lipid analytical methods, biophysical, compendial, molecular biology, sequencing and microbiology capabilities.

Oversee primarily non-GMP analytical testing supporting end-to-end process development, product characterization, non-GMP release and stability, manufacturing engineering runs and PPQ-related development activities.

Ensure ATO generates complete, accurate, reproducible, traceable and filing-ready development analytical data that underpin Module 3 (Quality) regulatory submissions, while supporting Regulatory CMC data requests across products and programs.

Provide broad technical leadership across separations, RNA critical quality attributes, lipids, biophysical methods, compendial testing, molecular biology, sequencing and microbiology, including bioburden and endotoxin testing.

Maintain reliable non-GMP release and stability execution across the full testing lifecycle, from sample receipt, study planning and test scheduling through data review, reporting and delivery against stability pull and testing commitments.

Lead the Integrations team responsible for test and request intake, analyst and assay scheduling, capacity and batching, stability study coordination and management, performance metrics, digital workflows, stakeholder engagement, cross-functional coordination and issue escalation.

Establish clear testing priorities, readiness expectations and delivery commitments in close partnership with Analytical Development, Process Development, CMC Stability, Manufacturing, MS&T, Quality, Regulatory CMC and Digital/IT.

Partner closely with QC and QA on the limited portfolio of phase-appropriate GMP testing required for early-phase material release, establishing qualified analytical coverage, appropriate controls, clear governance and robust records.

Build systematic analytical method-performance monitoring across system suitability, variability, control trends, method drift, repeats and atypical results, using those insights to identify risk early and enable method improvements and lifecycle decisions.

Work with Analytical Development, Process Development, Science & Technology and QC on method readiness, troubleshooting and transfer, creating a strong bridge between development analytical testing and GMP QC execution.

Establish and use operating dashboards covering right-first-time performance, turnaround time, on-time delivery, backlog, capacity utilization, investigations, retests, method performance and stability milestones, and translate emerging trends and constraints into action.

Improve laboratory throughput and cost effectiveness through standardized workflows, risk-based planning, cross-training, Lean practices, equipment optimization and automation without compromising scientific rigor, data quality or safety.

Modernize Benchling, LabVantage LIMS and related digital workflows, with a particular focus on structured data, study and sample traceability, scheduling and review, while reducing manual handoffs in partnership with Digital/IT.

Explore appropriate opportunities to bring Generative AI tools closer to laboratory and analytical operations, including support for knowledge access, structured data interpretation, workflow efficiency and scientific decision support, while maintaining appropriate controls, data integrity and human oversight.

Set clear expectations for quality, data integrity, training and EHS, maintaining fit-for-purpose procedures, documentation, investigation and escalation practices appropriate to the intended use of each analytical result.

Build a high-performing organization through workforce planning, manager coaching, performance management, clear goal setting, hiring, employee engagement, development, succession planning and structured rotations.

Strengthen leadership capabilities across the organization so managers can protect day-to-day delivery while continuously improving scientific, technical and operational performance.

Make risk-based cross-functional decisions on priorities, resources and trade-offs while protecting delivery commitments and strengthening collaboration across CMC.

Evolve the function, its operating model and its digital systems without disrupting ongoing analytical work or compromising submission-critical execution. Additional duties may be assigned from time to time.

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 digitize everywhere possible using the power of code to maximize our impact on patients.”.

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

Education: Degree in Analytical Chemistry, Chemistry, Biochemistry, Molecular Biology, Pharmaceutical Sciences, Life Sciences, Engineering, or a related technical discipline.

Experience: 15 years of relevant industry experience with a Bachelor’s degree or 10 years of relevant experience with a PhD in analytical development, analytical testing, technical operations, Quality Control, or related CMC laboratory functions.

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

PhD in a relevant scientific or engineering discipline is preferred.

Experience leading multi-technology analytical testing supporting development, non-GMP release and stability for mRNA/LNP, vaccines, biologics or other complex modalities.

Broad technical fluency across separations, RNA and lipid analyses, biophysical/compendial assays, molecular biology, sequencing and microbiology, with strong scientific judgment.

Demonstrated record of generating controlled analytical datasets supporting Module 3 filings, traceable source documentation and regulatory data requests.

Strong knowledge of non-GMP data integrity and fit-for-purpose methods, lifecycle management and phase-appropriate GMP requirements for early clinical programs.

Experience in analytical trending, method-performance monitoring, investigations and improvements that enable robust handoff from development to GMP QC.

Ability to build integrated scheduling, stability, metrics, portfolio prioritization and capacity-planning processes across multiple stakeholders.

Experience evolving ELN/LIMS, ideally Benchling and LabVantage, structured data models, digital interfaces and automation-enabled laboratory workflows.

Track record improving laboratory productivity, TAT, right-first-time performance and resource utilization while maintaining reliable delivery and high-quality data.

Proven people leadership through managers, including hiring, feedback, performance differentiation, coaching, staff development, succession and retention.

Executive communication and influence across Analytical Development, Process Development, CMC Stability, Manufacturing, MS&T, QC/QA, Regulatory CMC and Digital, aligned with Moderna’s values of 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.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Pay & Benefits

The salary range for this role is $167,000.00 - $300,700.00. 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.

• 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

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.

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.

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

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.