Lead Principal Scientist — Small Molecule Analytics

MSD Malaysia; West Point (PA); On-site; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Paid holidays

Vacation

Sick days

Job summary

Merck seeks a Principal Scientist to lead the Analytical Commercialization Technology group at Rahway, NJ and West Point, PA, driving late-stage small molecule drug product development in a cGMP environment.

You will mentor scientists, oversee method development and validation, contribute to regulatory submissions, and collaborate across regulatory, research, and manufacturing teams to deliver robust drug products.

Qualifications

• PhD or MS with extensive pharmaceutical development experience in small molecules.
• Strong background with UHPLC/HPLC, dissolution, GC, UV/IR, and Karl Fischer.
• Experience with method development and validation for regulatory submissions.
• Proven ability to author CTD sections for IND/NDA/MAA submissions.
• Excellent communication, teamwork, and leadership skills.

Responsibilities

• Lead a team in analytical method development and validation in a cGMP environment.
• Oversee drug product testing, characterization, stability studies, and specification development.
• Support manufacturing scale-up and validation activities.
• Prepare CMC documents for global regulatory submissions and address questions.
• Collaborate with regulatory, research, and manufacturing groups across functions.
• Coordinate drug product development and drive progress on multiple projects.
• Mentor scientists and build analytical capabilities within the organization.

Skills

Academic Presentations

Bioconjugation

Computational Chemistry

Creativity

Data Analysis

High-Throughput Experimentation

Organic Synthesis

Professional Networking

Project Leadership

Research Proposal Development

Scientific Leadership

Scientific Literature Search

Strategic Thinking

Structure Based Drug Design

Synthetic Chemistry

Education

PhD in Analytical Chemistry or related discipline

MS in Analytical Chemistry or related discipline

Tools

UHPLC/HPLC

Dissolution

GC

UV spectroscopy

IR spectroscopy

Karl Fischer titration

LC/MS

GC/MS

Job description

Merck seeks a Principal Scientist to lead the Analytical Commercialization Technology group at Rahway, NJ and West Point, PA, driving late-stage small molecule drug product development in a cGMP environment.

You will mentor scientists, oversee method development and validation, contribute to regulatory submissions, and collaborate across regulatory, research, and manufacturing teams to deliver robust drug products.