Director of Analytical Operations & Methodology

Biopharma Asia; Norwood (MA); On-site; USD 167,000 - 301,000; Full time

Job summary

Moderna is seeking a highly experienced leader to steer the Core Analytical Testing & Integrations organization in Norwood, MA. The role drives strategy, capacity planning, and execution standards while guiding a 30–50 person team across separations, RNA/lipid analytics, biophysical assays, and molecular biology.

You will oversee non-GMP release, stability, PPQ-related development, and collaborate with QC/QA for GMP testing as needed, with a strong emphasis on data integrity and regulatory

Qualifications

• Degree in Analytical Chemistry, Chemistry, Biochemistry, Molecular Biology, Pharmaceutical Sciences, Life Sciences, Engineering, or a related technical discipline.
• 15 years of relevant industry experience with a Bachelor’s degree or 10 years with a PhD in analytical development, analytical testing, technical operations, Quality Control, or related CMC laboratory functions.
• PhD in a relevant scientific or engineering discipline is preferred.
• Experience leading multi-technology analytical testing supporting development, non-GMP release and stability for complex modalities.

Responsibilities

• Lead the Core Analytical Testing & Integrations organization, setting strategy, capacity plans, execution standards and continuous-improvement priorities.
• Oversee 30–50 scientists, analysts, managers and integration specialists across multiple analytical domains.
• Ensure data readiness for Module 3 (Quality) regulatory submissions and regulatory data requests.
• Modernize Benchling, LabVantage LIMS and related digital workflows with focus on data integrity and traceability.
• Establish testing priorities and delivery commitments in partnership with cross-functional teams.
• Build dashboards and manage capacity planning, scheduling, and performance metrics.

Skills

Leadership

Strategic planning

Cross-functional collaboration

Regulatory knowledge

Project management

Education

PhD preferred in analytical/engineering

Bachelor's degree in Analytical Chemistry or related

Tools

Benchling ELN

LabVantage LIMS

Job description

Moderna is seeking a highly experienced leader to steer the Core Analytical Testing & Integrations organization in Norwood, MA. The role drives strategy, capacity planning, and execution standards while guiding a 30–50 person team across separations, RNA/lipid analytics, biophysical assays, and molecular biology.

You will oversee non-GMP release, stability, PPQ-related development, and collaborate with QC/QA for GMP testing as needed, with a strong emphasis on data integrity and regulatory