Senior Scientist, Sterile DP Process Development

Socket.dev; West Point (PA); On-site; USD 117,000 - 184,000; Full time

Job summary

Merck & Co., Inc. seeks a Senior Scientist to lead drug product development for sterile biologics and vaccines. The role focuses on establishing scalable commercial processes, technology transfers, and robust process validation for DP manufacturing sites.

Responsibilities include designing studies, implementing DOE, authoring reports, and supporting regulatory submissions while driving cost efficiency and process robustness across inline and pipeline programs.

Qualifications

• Bachelor of Science in Chemical Engineering or related field with 6 years of hands-on DP Process development, scale-up, tech transfer OR MS with 4 years OR PhD with no industry experience.
• Excellent interpersonal and communication skills for cross-functional collaboration.
• Experience with large biologics manufacturing and protein attributes.

Responsibilities

• Design and execute studies to develop and characterize sterile drug product processes and establish the commercial integrated control strategy.
• 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, incl. regulatory filings and product lifecycle management.
• Ensure DOE and proper experimental design; develop fit-for-purpose scale-down models.

Skills

Communication skills

Team collaboration

DOE

Analytical thinking

Education

B.S. in Chemical Engineering / related

M.S. in Chemical Engineering / related

Ph.D. with no industry experience

Job description

Merck & Co., Inc. seeks a Senior Scientist to lead drug product development for sterile biologics and vaccines. The role focuses on establishing scalable commercial processes, technology transfers, and robust process validation for DP manufacturing sites.

Responsibilities include designing studies, implementing DOE, authoring reports, and supporting regulatory submissions while driving cost efficiency and process robustness across inline and pipeline programs.