Senior Scientist, Sterile Biologics Commercialization

MSD; Northern (KY); Hybrid; USD 173,000 - 273,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical, dental, vision

401(k) retirement benefits

Paid holidays

Job summary

Merck & Co., Inc. is seeking a Principal Scientist to advance and commercialize sterile biologics programs. You will lead design, development, characterization, technology transfer, and validated processes for late-stage and commercial products.

You will drive PPQ readiness, scale-up to manufacturing, and support regulatory submissions with cross-functional teams in a fast-paced environment.

Qualifications

• Experience with biologics drug product process development and scale-up.
• Experience with technology transfer and PPQ readiness for sterile biologics.
• Familiarity with regulatory submissions and cGMPs for sterile products.

Responsibilities

• Lead biologics product design, development, and process validation for commercial programs.
• Drive tech transfer to pilot/manufacturing scales and establish robust scale-down models.
• Regulatory filing readiness, PPQ execution, and support for agency meetings.

Skills

Biologics

Drug product process development

Technology transfer

PPQ readiness

Process validation

Regulatory submissions

cGMPs

Sterile drug product

Statistical analysis

Education

Ph.D. or equivalent in Chemical Engineering or related field

Job description

Merck & Co., Inc. is seeking a Principal Scientist to advance and commercialize sterile biologics programs. You will lead design, development, characterization, technology transfer, and validated processes for late-stage and commercial products.

You will drive PPQ readiness, scale-up to manufacturing, and support regulatory submissions with cross-functional teams in a fast-paced environment.