Analytical Program Lead for Regulatory Filings

Moderna Therapeutics; Norwood (MA); On-site; USD 131,000 - 209,000; Full time

Job summary

Moderna Therapeutics is seeking an Analytical Program Lead to oversee analytical activities supporting regulatory filings (IND and BLA/MAA) and early lifecycle submissions across a family of programs.

You will define integrated analytical strategies, including specifications, control strategies, comparability, and assay lifecycle management, and establish commercial specs to enable licensure and post‑approval changes.

Qualifications

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with 5+ years of industry experience.
• MS/BS with 8+ years in analytical development or QC of biologics or vaccines.
• Experience authoring/regulatory justification and responding to health authority queries.
• Strong cross-functional leadership and regulatory excellence.

Responsibilities

• Lead analytical activities for regulatory filings (IND and BLA/MAA) and early lifecycle submissions.
• Define and execute integrated analytical strategies including specifications, control strategy, comparability, and assay lifecycle management.
• Establish commercial specifications, control strategies, and comparability frameworks for licensure and post-approval changes.
• Ensure analytical readiness for clinical studies and commercial manufacturing (qualification/validation, transfer, control strategies).
• Lead and author analytical sections of regulatory filings and responses to health authorities.

Skills

Cross-functional leadership

Regulatory collaboration

Analytical thinking

Regulatory writing

Education

Ph.D. in Analytical Chemistry or related field

MS/BS with 8+ years in analytical development or QC of biologics or vaccines

Job description

Moderna Therapeutics is seeking an Analytical Program Lead to oversee analytical activities supporting regulatory filings (IND and BLA/MAA) and early lifecycle submissions across a family of programs.

You will define integrated analytical strategies, including specifications, control strategies, comparability, and assay lifecycle management, and establish commercial specs to enable licensure and post‑approval changes.