Senior Scientist, Sterile Drug Product Process Development

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

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck is seeking a Senior Scientist to lead drug product process development for sterile biologics and vaccines. The role focuses on scalable, robust DP manufacturing processes and technology transfer to commercial sites.

You will design experiments, manage regulatory documentation, and drive optimization across inline programs while collaborating with global teams and maintaining cGMP standards.

Qualifications

• BS in Chemical Engineering or related field with six years of hands-on DP Process development experience; MS with four years; PhD with no experience.
• Excellent interpersonal and communication skills for cross-functional collaboration.
• Experience with sterile drug product manufacturing and protein attributes.

Responsibilities

• Design and execute studies to develop/characterize sterile drug product processes and commercial CMC strategies.
• Develop and transfer robust processes to DP commercial manufacturing sites.
• Lead process validation planning and technology transfers for inline/pipeline programs.

Skills

DOE

Process development

Regulatory submissions

Project management

cGMP knowledge

Data analysis

Education

B.S. in Chemical Engineering

M.S. in Chemical Engineering

Ph.D. in related field

Tools

Statistical analysis

Scale-up

Job description

Merck is seeking a Senior Scientist to lead drug product process development for sterile biologics and vaccines. The role focuses on scalable, robust DP manufacturing processes and technology transfer to commercial sites.

You will design experiments, manage regulatory documentation, and drive optimization across inline programs while collaborating with global teams and maintaining cGMP standards.