Lead Scientist, Process Development & Commercialization

MSD Malaysia; Rahway (NJ); On-site; USD 173,000 - 273,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ seeks a Principal Scientist, Engineering to lead late-stage small molecule manufacturing development, technology transfer, validation, and regulatory filing support across global sites.

You will mentor staff, apply QbD and DOE, drive process characterization, risk assessments, GDP, and work with cross-functional teams to deliver robust, scalable processes for commercial supply.

Qualifications

• Bachelor’s or master’s degree in chemical engineering with at least 11 years experience.
• Experience leading process development and characterization activities.
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• Experience supporting regulatory filings and process validation.
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• Mentoring and developing technical staff in a cross-functional setting.

Responsibilities

• Lead process characterization studies and DOE to establish robust manufacturing processes.
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• Drive technology transfer to commercial manufacturing sites.
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• Develop and execute regulatory filing strategies and process validation planning.
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• Mentor and develop technical staff within laboratory and cross-functional teams.

Skills

Process development

Regulatory filing

Mentoring

DOE

cGMP

Cross-functional leadership

Education

Bachelor's or master's in chemical engineering

PhD in Chemical Engineering

Tools

QbD principles

Job description

Merck & Co., Inc. in Rahway, NJ seeks a Principal Scientist, Engineering to lead late-stage small molecule manufacturing development, technology transfer, validation, and regulatory filing support across global sites.

You will mentor staff, apply QbD and DOE, drive process characterization, risk assessments, GDP, and work with cross-functional teams to deliver robust, scalable processes for commercial supply.