Senior Scientist, Small Molecule Analytics & cGMP

MSD; Rahway, West Point (NJ, PA); On-site; GBP 131,000 - 206,000; Full time

Job summary

Merck & Co., Inc. in San Francisco/Bay Area seeks a Principal Scientist to lead a team in analytical characterization for late-stage small molecule drug product development and commercialization.

You will drive method development, regulatory documentation, and cross-functional collaboration to ensure robust product quality. The role emphasizes mentoring, technical leadership, and partnerships with regulatory, research, and manufacturing groups across global projects.

Qualifications

• PhD in Analytical Chemistry or related discipline with seven or more years of relevant small molecule pharmaceutical development experience; OR MS with ten or more years.
• Strong background with UHPLC/HPLC, Dissolution, GC, UV and IR spectroscopy, and Karl Fischer titration.
• Extensive experience with method development and validation.
• Significant experience authoring regulatory CTD sections (IND, NDA, MAA, JNDA, etc.).
• Demonstrated problem-solving ability and excellent communication skills.
• Ability to mentor teams and lead cross-functional collaborations.
• Experience in analytical technology transfers and regulatory strategy planning.

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.
• Prepare CMC documents for global regulatory submissions and respond to questions.
• Collaborate with technical, regulatory, research, and manufacturing groups.
• Coordinate drug product development efforts and lead multiple projects.
• Mentor scientists and build/maintain scientific capabilities.

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 with 10+ years

Tools

UHPLC/HPLC

Dissolution

Gas Chromatography

UV spectroscopy

IR spectroscopy

Karl Fischer titration

LC/MS

GC/MS

Job description

Merck & Co., Inc. in San Francisco/Bay Area seeks a Principal Scientist to lead a team in analytical characterization for late-stage small molecule drug product development and commercialization.

You will drive method development, regulatory documentation, and cross-functional collaboration to ensure robust product quality. The role emphasizes mentoring, technical leadership, and partnerships with regulatory, research, and manufacturing groups across global projects.