Senior Scientist – Small Molecule Analytics & CMC Leadership

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

Benefits offered by this job

Bonus eligibility

Comprehensive benefits package

Job summary

Merck in Rahway, NJ and West Point, PA seeks a Principal Scientist to lead the Analytical Commercialization Technology group within ACiDS. You will drive analytical method development, validation, drug product testing, and cGMP investigations to support late-stage drug product development and commercialization.

You will mentor scientists, coordinate technology transfers, and collaborate across regulatory, research, and manufacturing to ensure robust CMC documentation and regulatory readiness.

Qualifications

• PhD in Analytical Chemistry or related discipline with seven or more years of small molecule pharmaceutical development experience; OR MS with ten or more years.
• Strong background with analytical techniques such as UHPLC/HPLC, dissolution, GC, UV, IR, and Karl Fischer titration.
• Extensive experience with method development and validation.
• Significant experience authoring CTD sections for regulatory submissions (IND, NDA, MAA, JNDA, etc.).
• Demonstrated problem-solving ability and excellent communication skills.

Responsibilities

• Lead a team of scientists in analytical method development and validation in a cGMP environment.
• Oversee drug product testing, characterization, stability studies, and specification development.
• Support manufacturing process scale-up and validation activities.
• Prepare CMC documents for global regulatory submissions and respond to regulatory questions.
• Collaborate with cross-functional groups including regulatory, research, and manufacturing.
• Coordinate development efforts across multiple projects and mentor junior scientists.

Skills

UHPLC/HPLC

Dissolution

Gas Chromatography

UV spectroscopy

IR spectroscopy

Karl Fischer

method development

regulatory submissions CTD

team leadership

mentoring

analytical technology transfers

Education

PhD in Analytical Chemistry

MS in Analytical Chemistry

Tools

LC/MS

GC/MS

UHPLC

Job description

Merck in Rahway, NJ and West Point, PA seeks a Principal Scientist to lead the Analytical Commercialization Technology group within ACiDS. You will drive analytical method development, validation, drug product testing, and cGMP investigations to support late-stage drug product development and commercialization.

You will mentor scientists, coordinate technology transfers, and collaborate across regulatory, research, and manufacturing to ensure robust CMC documentation and regulatory readiness.