Lead Scientist, Small Molecule Analytics & CMC

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

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement benefits

Paid time off

Job summary

HireLifeScience in Rahway, NJ, leads analytical commercialization for late-stage drug products. The Principal Scientist will drive method development, validation, and drug product testing in a collaborative, cross-functional team.

Responsibilities include CMC document preparation for regulatory submissions and mentoring scientists, with a focus on scale-up and regulatory readiness across global programs.

Qualifications

• PhD or MS with extensive pharma development experience in small molecules.
• Proven ability to develop and validate analytical methods in cGMP.
• Experience authoring CTD sections for regulatory submissions.

Responsibilities

• Lead a team in analytical method development and validation.
• Oversee drug product testing, characterization, and stability studies.
• Prepare CMC documents for global regulatory submissions.
• Collaborate with regulatory, manufacturing, and research groups.
• Mentor scientists and build analytical capabilities.
• Coordinate drug product development for multiple projects.

Skills

Academic Presentations

Bioconjugation

Computational Chemistry

Creativity

Data Analysis

High-Throughput

Organic Synthesis

Professional Networking

Project Leadership

Research Proposal

Leadership

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

Gas Chromatography

UV Spectroscopy

IR Spectroscopy

Karl Fischer Titration

Job description

HireLifeScience in Rahway, NJ, leads analytical commercialization for late-stage drug products. The Principal Scientist will drive method development, validation, and drug product testing in a collaborative, cross-functional team.

Responsibilities include CMC document preparation for regulatory submissions and mentoring scientists, with a focus on scale-up and regulatory readiness across global programs.