Senior Analytical Chemist, GMP & API Development

Jobtailor; New Jersey; On-site; USD 110,000 - 150,000; Full time

Job summary

Jobtailor in New Jersey is seeking an experienced pharmaceutical analytical scientist to lead development, validation, and documentation of analytical methods. You will troubleshoot technical issues and contribute to regulatory submissions, audits, and data integrity initiatives.

The role requires strong communication, adaptability, and collaboration across cross-functional teams, with occasional international travel to support API development and drug substance activities.

Qualifications

• Requires MS or PhD with 5+ years in pharmaceutical development.
• Experience with analytics for raw materials, intermediates, and drug substances.
• Strong written and verbal communication skills.
• Ability to adapt in a dynamic regulatory environment.
• Experience traveling abroad is a plus.
• Knowledge of API development and drug substance development.

Responsibilities

• Author analytical procedures, development and validation protocols and reports.
• Perform investigations and technical troubleshooting.
• Provide documentation for regulatory and internal audits.
• Apply data integrity concepts across workflows.
• Train staff on analytical techniques and problem solving.
• Influence external sites to improve test methods, workflows, and materials
• Support compliant, robust supply and drive lead-time reductions
• Contribute to World Class Supplier and Operationalizing Quality goals

Skills

Analytical Techniques

Chromatography

Spectroscopy

Data Integrity

cGMP Knowledge

Problem-Solving

Risk Management

API Development

Drug Substance Development

Product Specifications

Regulatory Submissions

Validation Protocols

Technical Reports

Analytical Procedures

Experimental Designs

Education

MS in Chemistry or related discipline

PhD in Analytical Chemistry or related discipline

Job description

Jobtailor in New Jersey is seeking an experienced pharmaceutical analytical scientist to lead development, validation, and documentation of analytical methods. You will troubleshoot technical issues and contribute to regulatory submissions, audits, and data integrity initiatives.

The role requires strong communication, adaptability, and collaboration across cross-functional teams, with occasional international travel to support API development and drug substance activities.