Global Vaccine Analytics Director | Method Lifecycle Lead

MSD Malaysia; West Point (PA); On-site; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays

Vacation

Sick days

Job summary

MSD Malaysia seeks a senior leader to guide a team of SMEs in analytical testing for vaccine methods across global labs. You will provide technical oversight, ensure compliance with GMP, and align method strategies with franchise priorities. Collaboration with CMC-Regulatory, QA, and external labs is essential.

The role emphasizes lifecycle management, reference standards, and risk mitigation to sustain robust analytical performance for vaccine products.

Qualifications

• Strong quality control background with GMP analytical methods experience.
• Experience leading technical teams, including goal setting and development planning.
• Cross-functional leadership and project coordination across QA, R&D, and regulatory.
• Experience with analytical method validation and regulatory guidelines.
• 10+ years in analytical testing or development with assay validation.

Responsibilities

• Oversee method lifecycle management and optimization.
• Lead reference standard and critical reagent strategies.
• Coordinate testing strategies and troubleshooting workshops.
• Support regulatory submissions and method transfers.
• Drive method modernization and risk assessment activities.

Skills

Quality control

Team leadership

Cross-functional

Method validation

ICH Q2/Q14

Vaccine analytics

Education

Master's or Bachelor’s

PhD acceptable

Job description

MSD Malaysia seeks a senior leader to guide a team of SMEs in analytical testing for vaccine methods across global labs. You will provide technical oversight, ensure compliance with GMP, and align method strategies with franchise priorities. Collaboration with CMC-Regulatory, QA, and external labs is essential.

The role emphasizes lifecycle management, reference standards, and risk mitigation to sustain robust analytical performance for vaccine products.