Principal Scientist, Sterile Drug Product Commercialization

MSD; West Point (PA); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement plan

401(k) plan

Paid holidays

Vacation

Sick days

Job summary

Merck & Co., Inc. in the United States is seeking an Associate Principal Scientist to advance biologics pipeline programs. You will lead process characterization, scale-up, transfer and process validation activities to support late-stage and commercial products.

The role requires deep expertise in sterile biologics manufacturing, regulatory interactions, and cross-functional leadership to deliver robust commercialization strategies.

Qualifications

• Experience with drug product process development, optimization, and/or process characterization of biologics.
• Experience with at scale biologics drug product manufacturing and fill finish operations.
• Technical expertise in sterile drug product fill finish related manufacturing processes for large molecules.

Responsibilities

• Leads cross functional biologics drug product programs through filing and PPQ readiness.
• Drives process development, tech transfer, and validation at commercial sites.
• Supports regulatory submissions and provides technical mentoring.

Skills

Biologics process development

Scale-up

Technology transfer

Process characterization

PPQ readiness

Regulatory submissions

Technical leadership

Communication (oral/written)

Education

B.S. in Chemical Engineering

M.S. in Chemical Engineering or related field

Ph.D. in Chemical Engineering or related field

Job description

Merck & Co., Inc. in the United States is seeking an Associate Principal Scientist to advance biologics pipeline programs. You will lead process characterization, scale-up, transfer and process validation activities to support late-stage and commercial products.

The role requires deep expertise in sterile biologics manufacturing, regulatory interactions, and cross-functional leadership to deliver robust commercialization strategies.