Senior Scientist, Analytical Development - Small Molecule

Insmed; Williamstown (NJ); On-site; USD 127,000 - 166,000; Full time

Job summary

Insmed seeks a Senior Scientist in Analytical Development to lead method development and validation for small-molecule drug substances and products across early- to late-stage programs. The role supports regulatory compliance and technology transfer while collaborating across cross-functional teams in the Bridgewater, NJ office.

Responsibilities include designing and executing method validation, overseeing method transfer to manufacturing and quality laboratories with thorough documentation, and

Qualifications

• Bachelor's degree in chemistry, biochemistry, or related field with 6+ years experience
• Hands-on expertise in analytical testing for inhalation, solid oral, and liquid dosage forms
• Proficiency with HPLC, GC, LC-MS, NMR, UV, and FTIR analytical techniques
• Strong knowledge of regulatory requirements including cGxP, CMC, ICH, and compendial standards
• Experience with inhalation and combination products preferred

Responsibilities

• Lead development and optimization of analytical methods for drug substances, intermediates, and products
• Design and execute method validation activities in compliance with ICH, FDA, EMA, and regulatory guidelines
• Oversee method transfer to manufacturing and quality laboratories with comprehensive documentation
• Author and review analytical sections of regulatory submissions including IND, IMPD, and NDA/MAA
• Serve as analytical lead for CMC programs, managing deliverables and external service providers

Skills

Analytical method development

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in chemistry, biochemistry, or related field

Master's degree in a related field

Tools

HPLC

GC

LC-MS

NMR

UV

FTIR

Job description

Insmed seeks a Senior Scientist in Analytical Development to lead method development and validation for small-molecule drug substances and products across early- to late-stage programs. The role supports regulatory compliance and technology transfer while collaborating across cross-functional teams in the Bridgewater, NJ office.

Responsibilities

• Lead development and optimization of analytical methods for drug substances, intermediates, and products
• Design and execute method validation activities in compliance with ICH, FDA, EMA, and regulatory guidelines
• Oversee method transfer to manufacturing and quality laboratories with comprehensive documentation
• Author and review analytical sections of regulatory submissions including IND, IMPD, and NDA/MAA
• Serve as analytical lead for CMC programs, managing deliverables and external service providers

Requirements

• Bachelor's degree in chemistry, biochemistry, or related field with 6+ years experience; or master's degree with 4+ years experience
• Hands-on expertise in analytical testing for inhalation, solid oral, and liquid dosage forms
• Proficiency in HPLC, GC, LC-MS, NMR, UV, and FTIR analytical techniques
• Strong knowledge of regulatory requirements including cGxP, CMC, ICH, and compendial standards
• Advanced proficiency in Microsoft Office tools
• Experience with inhalation and combination products preferred

Compensation

$127,000-$165,500 annual