Lead Scientist, Small Molecule Analytics

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

Job summary

Merck seeks a Principal Scientist to lead the Analytical Commercialization Technology group at Rahway, NJ and West Point, PA. You will drive analytical method development, drug product testing, and regulatory documentation to advance late-stage small molecule programs.

Strong leadership and expertise in UHPLC/HPLC, LC/MS, method validation, and cross-functional collaboration with regulatory, research, and manufacturing teams are required.

Qualifications

• PhD in Analytical Chemistry or MS with 7+ or 10+ years in small molecule pharmaceutical development.
• Experience with UHPLC/HPLC, dissolution, GC, UV/IR, and Karl Fischer.
• Proven track record in method development/validation and regulatory CTD submissions.
• Strong communication, leadership, and mentoring abilities.

Responsibilities

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

MS in Chemistry

Tools

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. You will drive analytical method development, drug product testing, and regulatory documentation to advance late-stage small molecule programs.

Strong leadership and expertise in UHPLC/HPLC, LC/MS, method validation, and cross-functional collaboration with regulatory, research, and manufacturing teams are required.