Lead, Analytical Method Transfer (GMP/ICH)

RiseMe; Norwood (MA); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Healthcare benefits

Paid time off

Fitness programs

Location-based perks

Job summary

Moderna is seeking a scientific lead to transfer analytical methods from Development into ATO and QC laboratories, ensuring robust, scientifically sound methods are ready for routine testing. You will design transfer strategies, assess readiness, and troubleshoot issues while aligning with regulatory expectations.

The role requires hands-on method development expertise, strong GMP knowledge, and collaboration with cross-functional teams across Analytical Development, QC, and Regulatory.

Qualifications

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field with 2+ years of relevant industry experience, or M.S. with 8+ years, or B.S./B.A. with 12+ years of relevant experience in analytical development, analytical sciences, Quality Control, or related pharmaceutical development functions.

Responsibilities

• Serve as the Analytical Sciences technical transfer lead for analytical methods moving from Analytical Development into ATO and QC laboratories, driving transfer activities from readiness assessment through execution, troubleshooting, and transfer closeout.
• Perform rigorous method-transfer readiness assessments using development and qualification data, robustness knowledge, method risk assessments, critical method parameters, system suitability, assay controls, reference standards, critical reagents, sample preparation, data processing, and known method limitations.
• Define and execute phase-appropriate transfer strategies, protocols, acceptance criteria, and study designs that reflect the method’s intended use, product-development phase, scientific maturity, and patient/product risk.
• Lead scientific troubleshooting and root-cause investigations during transfer and early routine use, designing targeted experiments to distinguish method, sample, reagent, instrument, software, analyst, and laboratory-environment sources of variability and implementing durable corrective actions.

Skills

Analytical method development

Method transfer

GMP knowledge

ICH Q2(R2) / Q14

Education

Ph.D. in Analytical Chemistry or related field

Job description

Moderna is seeking a scientific lead to transfer analytical methods from Development into ATO and QC laboratories, ensuring robust, scientifically sound methods are ready for routine testing. You will design transfer strategies, assess readiness, and troubleshoot issues while aligning with regulatory expectations.

The role requires hands-on method development expertise, strong GMP knowledge, and collaboration with cross-functional teams across Analytical Development, QC, and Regulatory.