Senior Scientist, Sterile Drug Product Development

Merck & Co.; West Point (PA); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical benefits

Retirement benefits

Job summary

Merck & Co., Inc. in West Point, PA, seeks a Senior Scientist to lead drug product process development for sterile products, vaccines, and biologics. You will design studies, transfer robust processes, and support regulatory submissions.

The role emphasizes DOE, scale‑up, technology transfer, and platform engineering for commercial manufacturing, with travel up to 25% in a fast‑paced, collaborative environment.

Qualifications

• Bachelor of Science in Chemical Engineering or related field with six years of hands-on DP process development experience or MS with four years or PhD with no industry experience.
• Excellent interpersonal and communication skills for cross-functional collaboration.
• Experience in the process development and manufacturing of large biological molecules with understanding of protein attributes.

Responsibilities

• Design and execute studies to develop and characterize sterile drug product processes.
• Develop and transfer robust processes to the DP commercial manufacturing site.
• Build strategy and technical framework for process validation at commercial sites.
• Manage DP activities for inline and pipeline programs, including regulatory filings.
• Ensure DOE and appropriate experimental design principles are used.
• Author technical protocols and reports for regulatory submissions.
• Lead cross-functional teams on process optimization and platform development.

Skills

Adaptability

Biochemistry

Biologics

Bioprocess Engineering

Bioproducts

Bioreactors

Biotechnology

cGMP Regulations

Chemical Engineering

Chemistry

Chromatographic Techniques

Clinical Judgment

Clinical Manufacturing

Commercialization

Design of Experiments (DOE)

Detail‑Oriented

Good Manufacturing Practices (GMP)

Process Design

Process Development (PD)

Process Optimization

Process Scale Up

Process Verification

Regulatory Submissions

Sample Management

Education

BS in Chemical Engineering or related field with six years of hands-on DP process development experience

MS with four years of experience in DP process development

PhD with no industry experience

Job description

Merck & Co., Inc. in West Point, PA, seeks a Senior Scientist to lead drug product process development for sterile products, vaccines, and biologics. You will design studies, transfer robust processes, and support regulatory submissions.

The role emphasizes DOE, scale‑up, technology transfer, and platform engineering for commercial manufacturing, with travel up to 25% in a fast‑paced, collaborative environment.