Vaccine Analytical Methods Lead

MSD Malaysia; Northern (KY); Hybrid; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision care

401(k) retirement plan

Paid holidays

Vacation

Job summary

MSD Malaysia is seeking a Senior Lead for Analytical Methods within Global Quality Large Molecule Analytical Sciences. You will guide SMEs across vaccine franchises, ensuring robust analytical testing and lifecycle management for HPV and PCV programs, with strong collaboration across QA, R&D, and external partners.

Responsibilities include method lifecycle oversight, regulatory support, and cross‑functional leadership to deliver reliable, compliant results in a fast-paced vaccine setting.

Qualifications

• Strong quality control background with GMP analytical methods support.
• Experience leading technical teams and cross‑functional projects.
• Familiarity with analytical method validation and regulatory guidelines.

Responsibilities

• Lead SME teams across vaccine franchises to ensure method effectiveness.
• Oversee method lifecycle management and critical reagent strategy.
• Coordinate testing strategy and risk assessments.
• Support regulatory submissions and method transfer.
• Collaborate with QA, R&D, and external partners.

Skills

Quality control

GMP analytical methods

Team leadership

Cross-functional leadership

Analytical method validation

Tech transfer

ICH Q2/Q14

Regulatory liaison

Project timeline management

Communication skills

Education

Master’s degree

Bachelor’s degree

PhD degree

Job description

MSD Malaysia is seeking a Senior Lead for Analytical Methods within Global Quality Large Molecule Analytical Sciences. You will guide SMEs across vaccine franchises, ensuring robust analytical testing and lifecycle management for HPV and PCV programs, with strong collaboration across QA, R&D, and external partners.

Responsibilities include method lifecycle oversight, regulatory support, and cross‑functional leadership to deliver reliable, compliant results in a fast-paced vaccine setting.