Lead Scientist, Process Development & Commercialization

Merck & Co.; Rahway (NJ); On-site; USD 173,000 - 273,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Benefits package

Job summary

Merck & Co., Rahway, NJ, seeks a Principal Scientist, Engineering to lead late-stage small molecule programs from development to commercialization. You will drive process characterization, technology transfer to commercial sites, and regulatory filing support while mentoring staff.

This role emphasizes cGMP compliance, GDP, and QbD application, with broad cross-functional collaboration across our global network and strategic decision-making capabilities.

Qualifications

• Bachelor's or master's in chemical engineering or related field with 11 years of relevant experience in process development; or Ph.D. in Chemical Engineering with 7 years post-doctorate.
• Experience in chemical process development including designing experiments for robustness and scalability.
• Ability to lead technical teams and influence stakeholders across multiple functions.

Responsibilities

• Lead process characterization studies to develop robust manufacturing processes.
• Coordinate technology transfers to commercial manufacturing sites.
• Provide regulatory filing support and develop control strategies with process validation planning.
• Mentor technical staff and drive cross-functional development programs.
• Apply QbD, DOE, and risk management in development and optimization.
• Ensure cGMP and GDP compliance across development and manufacturing.

Skills

Process development

Process characterization

DOE

Regulatory filing

Mentorship

Cross-functional

Quality by Design

Statistical data analysis

Technology transfer

cGMP

Education

Bachelor's or master's in chemical engineering or related field with 11+ years experience or PhD with 7+ years

Job description

Merck & Co., Rahway, NJ, seeks a Principal Scientist, Engineering to lead late-stage small molecule programs from development to commercialization. You will drive process characterization, technology transfer to commercial sites, and regulatory filing support while mentoring staff.

This role emphasizes cGMP compliance, GDP, and QbD application, with broad cross-functional collaboration across our global network and strategic decision-making capabilities.