Senior Scientist, Small Molecule Process Development

Merck; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Benefits package

Job summary

Merck in Rahway, NJ is seeking a Senior Scientist to lead cross-functional efforts in small molecule drug substance development and commercialization. You will drive process understanding, risk-based design, and robust transfer from development to manufacturing across lab, pilot plant, and production environments.

The role emphasizes cGMP, data integrity, and lifecycle optimization, with collaboration across research, manufacturing, quality, regulatory, and external partners."

Qualifications

• Demonstrated experience in chemical process development, commercialization, or manufacturing support of small molecule pharmaceutical processes.
• Experience designing and executing experimental programs to solve complex chemical engineering and manufacturing challenges.
• Strong communication and ability to work in multidisciplinary teams; commitment to safety and compliance.

Responsibilities

• Lead process understanding, characterization, and commercialization activities for small molecule drug substance manufacturing processes.
• Design and execute scientifically sound experimental programs using Quality Risk Management (QRM) and Quality by Design (QbD) principles.
• Apply statistical methods, Design of Experiments (DoE), and data-driven decision making to establish process robustness and control strategies.
• Develop, defend, and communicate technical recommendations to cross-functional teams, manufacturing sites, and senior leadership.
• Support technology transfer activities from development laboratories to pilot plants and commercial manufacturing facilities.
• Author and review technical reports, validation documents, regulatory filing content, control strategies, and lifecycle management documentation.
• Provide technical leadership during process performance qualification (PPQ), process validation, and commercial manufacturing campaigns.
• Lead or support investigations, risk assessments, change controls, deviations, and corrective and preventive actions (CAPAs).
• Collaborate with internal and external manufacturing partners to resolve technical challenges and implement process improvements.
• Utilize first-principles engineering, process modeling, and scale-up methodologies to support manufacturing and process optimization.
• Champion a culture of safety, compliance, operational excellence, and continuous improvement.

Skills

API Manufacturing

Chemical Engineering

Chemical Manufacturing

Commercialization

Design of Experiments

Manufacturing Processes

Manufacturing Technologies

Pharmaceutical Process Development

Process Control

Process Improvements

Process Scale Up

Product Commercialization

Small Molecule Synthesis

Technology Development

Technology Transfer

Education

Ph.D. in Chemical Engineering or related discipline

B.S. or M.S. in Chemical Engineering or related discipline with 5+ years industrial experience

Tools

JMP

Minitab

Python

Job description

Merck in Rahway, NJ is seeking a Senior Scientist to lead cross-functional efforts in small molecule drug substance development and commercialization. You will drive process understanding, risk-based design, and robust transfer from development to manufacturing across lab, pilot plant, and production environments.

The role emphasizes cGMP, data integrity, and lifecycle optimization, with collaboration across research, manufacturing, quality, regulatory, and external partners."