Senior Principal Scientist, Large Molecule Analytical Transfer

Merck; West Point (PA); On-site; USD 120,000 - 160,000; Full time

Job summary

Merck is seeking a senior analyst to lead complex analytical transfers for large molecule programs, including ADCs, mAbs, and vaccines. The role involves oversight of method transfers, validations, and life-cycle management across global teams.

Collaborate with product development, manufacturing, and testing sites, drive continuous improvement, and support regulatory documentation for biologics and vaccines in a fast-paced environment.

Qualifications

• Bachelor's degree in biology, chemistry, biochemistry, or related science with six years of relevant industry knowledge in systematic development, validation, and/or quality control (QC)
• Master's degree in biology, chemistry, biochemistry, or related science with four years of relevant industry knowledge in systematic development, validation, and/or quality control (QC)
• PhD in biology, chemistry, biochemistry, or related science with one year of relevant industry knowledge in systematic development, validation, and/or quality control (QC)

Responsibilities

• Lead complex analytical transfers for the team including ADCs, mAbs and Vaccines
• Lead method transfers and/or validations across vaccine and biologics programs including quality risk assessments/gap analysis
• Interface across our Company network to ensure the successful commercialization of assays promoting our pipeline programs
• Involvement in development, troubleshooting and optimization of analytical methods
• Continuous improvement using laboratory standardization and lean six sigma methodologies
• Assay Life Cycle activities across various large molecule franchises and analytical platforms
• Support facility start-up activities and analytical testing at CMOs or contract labs

Skills

ICH Knowledge

Method Transfer

cGMP Experience

Analytical Validation

Vaccine/Biologics

Project Management

Cross-functional

Education

Bachelor's degree

Master's degree

PhD

Job description

Merck is seeking a senior analyst to lead complex analytical transfers for large molecule programs, including ADCs, mAbs, and vaccines. The role involves oversight of method transfers, validations, and life-cycle management across global teams.

Collaborate with product development, manufacturing, and testing sites, drive continuous improvement, and support regulatory documentation for biologics and vaccines in a fast-paced environment.