Director, Analytical Development

Moderna; Norwood (KY); On-site; USD 167,000 - 301,000; Full time

Benefits offered by this job

Competitive healthcare

Generous time off & PTO

Location‑specific perks

Job summary

Moderna seeks a senior leader to own the Innovative Technology and Methodology capability within Analytical Development. You will set strategy for next‑generation analytical methods, translating science into scalable, regulatory‑compliant solutions across QC and clinical/commercial products.

You will partner across Analytical Sciences, QC, AST, and other CMC functions to drive method modernization, support validation, transfer, and lifecycle adoption, while advancing automation and digital

Qualifications

• Ph.D. in Analytical Chemistry or related field with 12+ years industry experience, or MS/BS with 18+ years in analytical development/technology.
• Deep expertise in analytical method development across multiple domains.
• Knowledge of ICH Q14 and Q2(R2) preferred; lifecycle management experience.

Responsibilities

• Lead the Innovative Technology and Methodology capability and set the strategy for next‑gen analytical methods.
• Build an end‑to‑end innovation pipeline and oversee proof‑of‑concept through transfer and lifecycle adoption.
• Partner with Analytical Sciences, QC, AST, and other functions to translate needs into prioritized programs.
• Drive modernization of methodologies across separation sciences, sequencing, biophysics, bioassays, and other platforms.
• Oversee method transformation to replace legacy methods with scalable, automation‑ready approaches.
• Define implementation pathways including bridging, transfer, qualification/validation, and digital integration.
• Embed risk‑based development aligned with ICH and regulatory expectations; ensure robust regulatory strategy.

Skills

Analytical chemistry

Regulatory knowledge

Cross-functional leadership

ICH Q14 / Q2(R2) familiarity

GMP & data integrity

Automation & digital analytics

mRNA / nucleic acids knowledge

Strategic planning & roadmapping

Executive stakeholder management

Technology transfer & validation

Education

Ph.D. in Analytical Chemistry or related

MS/BS with extensive industry experience

Job description

The Role

In this role, you will lead the Innovative Technology and Methodology capability within Analytical Development and report to the Head of Analytical Development. You will set and execute the strategy for next-generation analytical methods and technologies, translating emerging scientific capabilities into robust, scalable, and sustainable solutions across the Quality Control network. Success in this role requires the ability to connect scientific innovation with product and control-strategy needs, operational realities, regulatory expectations, and measurable business value. You will partner closely with Analytical Sciences, Analytical Product Leads (APLs), Analytical Sciences & Technology (AST), Quality Control (QC), and other CMC functions to build an end-to-end pathway from technology identification and proof of concept through method development, transfer, implementation, and lifecycle adoption.

Here’s What You’ll Do

• Lead the Innovative Technology and Methodology capability within Analytical Development, establishing the vision, scientific strategy, portfolio, and roadmap for next-generation analytical methods and technologies across clinical and commercial products.

• Build and govern an end-to-end analytical innovation pipeline that identifies unmet analytical needs, evaluates emerging technologies, prioritizes opportunities, develops proof-of-concept solutions, and advances successful technologies through development, qualification or validation strategy, transfer, and implementation.

• Partner closely with Analytical Sciences, APLs, AST, and QC to translate product knowledge, control-strategy needs, method performance trends, investigations, and network pain points into prioritized innovation programs with clear analytical target profiles and intended-use requirements.

• Drive development and modernization of analytical methodologies across relevant scientific domains, including separation sciences, molecular and sequencing technologies, biophysical and spectroscopic methods, bioassays, microbiology, advanced characterization, and other emerging analytical platforms appropriate to mRNA and advanced therapeutic modalities.

• Lead method transformation across the QC network by enabling replacement, simplification, consolidation, and harmonization of legacy methods with more robust, higher-throughput, automation-ready, and scalable platform approaches where scientifically and regulatorily justified.

• Partner with AST, QC, ATO, Quality, Regulatory, Digital, and Automation teams to establish practical implementation pathways for innovative methods, including bridging, transfer, validation, change management, digital integration, training, and sustained method performance across internal and external testing sites.

• Embed science- and risk-based analytical development principles consistent with evolving global expectations, including ICH Q14 and Q2(R2), to ensure new methodologies are fit for intended purpose, appropriately robust, lifecycle-ready, and supported by a defensible regulatory strategy.

• Establish a strong external innovation network across instrument and technology vendors, biotechnology companies, academic collaborators, consortia, and other external partners; actively scout emerging capabilities and determine where external innovation can accelerate Moderna analytical strategy.

• Advance automation-, digital-, and data-enabled analytical methodologies in partnership with relevant functions, designing methods and workflows that reduce manual variability, improve data integrity and review efficiency, and enable scalable deployment across the analytical network.

• Define clear success measures and business cases for the innovation portfolio, including improvements in method robustness, invalid/OOS/OOT rates, turnaround time, throughput, labor intensity, cost, method harmonization, and successful network adoption; use these measures to prioritize investment and stop or redirect low-value efforts early.

• Develop, coach, and inspire scientific talent while creating a culture that combines curiosity and experimentation with disciplined execution, technical rigor, cross-functional accountability, and a strong focus on translating innovation into sustained organizational impact.

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

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Bioengineering, or a related scientific field with 12+ years of relevant industry experience, or M.S. or B.S. with 18+ years of relevant experience in analytical development, analytical technology, pharmaceutical sciences, or related areas for biologics, vaccines, or advanced therapeutic modalities.

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

• Demonstrated ability to define and execute an analytical innovation or technology strategy and to translate emerging science into methods and capabilities that are adopted in development and/or GMP Quality Control environments.

• Deep scientific expertise in analytical method development with broad understanding across multiple analytical domains and the ability to assess the strengths, limitations, and intended-use suitability of emerging technologies.

• Strong understanding of analytical procedure lifecycle principles, including analytical target profiles, robustness and risk assessment, qualification/validation, method transfer, continued performance monitoring, and lifecycle change management; practical knowledge of ICH Q14 and Q2(R2) is strongly preferred.

• Proven experience moving new analytical technologies from concept or proof of concept through implementation, including cross-functional alignment, technology transfer, validation strategy, change control, and adoption within clinical and/or commercial testing networks.

• Strong knowledge of GMP, data integrity, global regulatory expectations, and inspection readiness, with the scientific judgment to balance innovation, phase-appropriate development, compliance, and operational scalability.

• Experience with analytical automation, high-throughput workflows, digital integration, advanced data analysis, AI/ML-enabled analytical applications, or other laboratory-of-the-future capabilities is highly desirable.

• Experience with mRNA, nucleic acids, lipid nanoparticles, vaccines, biologics, or other advanced modalities is strongly preferred, together with an understanding of how analytical technologies support product characterization, control strategy, comparability, stability, and manufacturing.

• Demonstrated success leading complex, matrixed initiatives across Analytical Development, QC, AST/MS&T, Process Development, Manufacturing, Quality, Regulatory, Digital, and external partners, with the ability to influence senior stakeholders without relying solely on direct authority.

• Strong external orientation and ability to build productive collaborations with technology vendors, academic groups, consortia, CROs/CDMOs, and peer organizations to identify, evaluate, and accelerate high‑value analytical innovation.

• Demonstrated success developing high‑performing scientific talent and creating an environment where rigorous experimentation, learning, prioritization, and execution translate into scalable organizational capabilities.

• Excellent scientific communication, executive presence, stakeholder management, and organizational leadership skills, along with a desire to make an impact as part of a high-growth, transformational 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.

Moderna is a smoke‑free, alcohol‑free, and drug‑free work 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 $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.

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.

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 NoticeThis 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.