Analytical Development Bridge Lead: Method Transfer

RXinsider LTD.; Norwood (MA); On-site; USD 90,000 - 144,000; Full time

Benefits offered by this job

Healthcare

Well-being resources

Family planning

Paid time off

Savings & investments

Location perks

Job summary

Moderna is seeking a Principal Research Associate to bridge Analytical Development (AD) with cross-functional partners including AST, QC, ATO, and QA. You will drive robust method development for clinical-stage qualification and commercial validation-readiness, with emphasis on method transfer, troubleshooting, and lifecycle improvements.

The role requires hands-on expertise in HPLC, absorption, and molecular biology assays, and ownership of investigations across development and operations.

Qualifications

• The ideal candidate brings deep technical expertise in analytical methods, including HPLC, absorption, and molecular biology assays.
• Experience with analytical method transfer to QC or external labs.
• Proven troubleshooting and investigator lead in GMP or late-stage development environments.
• Understanding of CQA frameworks, lifecycle management, and regulatory expectations.

Responsibilities

• Serve as liaison between Method Development, AST, ATO, and QC with aligned analytical method expectations.
• Represent Analytical Development in cross-functional forums with AS&T and QC.
• Ensure methods meet technical, operational, and regulatory requirements before qualification or validation.
• Act as SME for investigations and performance issues across development and QC.
• Influence method development and continuous improvement based on feedback and lifecycle needs.
• Collaborate with Quality and AST on deviation investigations, CAPAs, and change controls.
• Analyze complex datasets to inform performance and variability.
• Author and review protocols, reports, and method lifecycle documents.

Skills

HPLC

Absorption

Molecular Biology assays

Education

MS in a relevant field

BS in a relevant field

Job description

Moderna is seeking a Principal Research Associate to bridge Analytical Development (AD) with cross-functional partners including AST, QC, ATO, and QA. You will drive robust method development for clinical-stage qualification and commercial validation-readiness, with emphasis on method transfer, troubleshooting, and lifecycle improvements.

The role requires hands-on expertise in HPLC, absorption, and molecular biology assays, and ownership of investigations across development and operations.