Director, Vaccine Analytics & Method Excellence

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

Benefits offered by this job

Annual bonus

Long-term incentive

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays

Vacation

Sick days

Job summary

Merck & Co., Inc. seeks a senior leader to manage a team of SMEs delivering in-depth support for vaccine analytical methods.

You will oversee method lifecycle management, reference standards, and assay validation across HPV/PCV franchises, interfacing with QA, CMC-Regulatory, and external labs to ensure compliant release and lifecycle initiatives. The role requires a strong GMP background, 10+ years in analytical testing, and demonstrated leadership in cross-functional settings to meet deadlines

Qualifications

• Strong Quality control background with GMP analytical methods experience.
• Experience defending technical content during inspections.
• Cross-functional leadership with project accountability.
• Experience with Analytical Method Validation and ICH Q2/Q14.

Responsibilities

• Lead SMEs and coordinate analytical testing support across vaccine franchises.
• Oversee method lifecycle management, reference standards, and reagents.
• Drive method optimization, risk assessments, and regulatory submissions.
• Mentor and develop scientific talent within the team.
• Collaborate with QA, R&D, CMC-Regulatory and external partners.

Skills

Quality leadership

GMP analytical methods

Team management

Cross-functional collaboration

Analytical method development

Regulatory submissions

Project timeline management

Mentoring scientific talent

Education

15 years experience + Master/Bachelor

10 years experience + PhD in analytical testing

Job description

Merck & Co., Inc. seeks a senior leader to manage a team of SMEs delivering in-depth support for vaccine analytical methods.

You will oversee method lifecycle management, reference standards, and assay validation across HPV/PCV franchises, interfacing with QA, CMC-Regulatory, and external labs to ensure compliant release and lifecycle initiatives. The role requires a strong GMP background, 10+ years in analytical testing, and demonstrated leadership in cross-functional settings to meet deadlines