Senior Scientist, Analytical Development - Small Molecule

Insmed; New York (NY); Vor Ort; USD 127.000 - 166.000; Vollzeit

Zusammenfassung

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.

Lead development and optimization of analytical methods using HPLC, GC, LC-MS, NMR, UV, and FTIR, and ensure readiness for IND, IMPD, and NDA submissions.

Qualifikationen

• Bachelor's degree in chemistry, biochemistry, or related field.
• 6+ years experience or 4+ with master's degree.
• Hands-on analytical testing for dosage forms (inhalation, solid oral, liquid).
• Strong knowledge of regulatory requirements including cGxP, ICH, and compendial standards.

Aufgaben

• 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

Kenntnisse

Analytical method development

Method validation

Regulatory knowledge (ICH, FDA, EMA)

Ausbildung

Bachelor's degree in Chemistry

Master's degree in Chemistry

Tools

HPLC

GC

LC-MS

NMR

UV

FTIR

Jobbeschreibung

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