Principal Scientist, Biologics Process Development

MSD; Upper Gwynedd Township (Montgomery County); On-site; USD 173,000 - 273,000; Full time

Job summary

Merck & Co., Inc. in the USA (West Point, PA) seeks a Principal Scientist to lead process characterization, scale-up, technology transfer and process validation for late-stage and commercial biologics programs.

Responsibilities include cross-functional DP oversight, PPQ readiness, regulatory support, and mentoring. The role advances standardized platform approaches for sterile product manufacturing and commercialization.

Qualifications

• Experience with biologics drug product development and characterization
• Experience with scale-up and fill-finish operations
• Experience with late-stage commercialization and PPQ
• Technical expertise in sterile drug product manufacturing
• Experience with tech transfer and scale-up to pilot/manufacturing
• Strong written and oral communication in cross-functional teams

Responsibilities

• Lead design, development, and tech transfer of biologics DP
• Oversee PPQ readiness, stability studies, and regulatory filings
• Drive process development and validation at commercial sites
• Develop scale-down models and platform engineering for sterile products
• Mentor team members and provide strategic guidance

Skills

Biologics process development

Tech transfer

Process characterization

PPQ readiness

Regulatory submissions

Leadership

Education

B.S. in Chemical Engineering / related field

M.S. in Chemical Engineering / related field

Ph.D. in Chemical Engineering / related field

Job description

Merck & Co., Inc. in the USA (West Point, PA) seeks a Principal Scientist to lead process characterization, scale-up, technology transfer and process validation for late-stage and commercial biologics programs.

Responsibilities include cross-functional DP oversight, PPQ readiness, regulatory support, and mentoring. The role advances standardized platform approaches for sterile product manufacturing and commercialization.