Sr. Scientist I - Extractables & Leachables

ALACAM

Wilmington, NC, US
Not specified; not specified; competitive salary +...
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Extractables and leachables testing
Lc/ms method development
Gc/ms volatile compound analysis
** Alcami is seeking a Senior Scientist I specializing in Extractables and Leachables (E&L) testing to ensure patient safety and regulatory compliance for pharmaceutical products. The role requires extensive experience in mass spectrometry and chromatography, along with a solid background in GMP environments. **

Job Summary

  • The Senior Scientist I will support Extractables and Leachables testing to identify compounds that may leach from manufacturing components into liquid formulations.
  • This hands-on position emphasizes method development using mass spectrometry while maintaining strict GMP rigor for patient safety and regulatory compliance.
  • Alcami offers a competitive salary, exceptional benefits package including medical and dental coverage, and opportunities for professional growth within a team dedicated to advancing life-saving drugs.

Matching Summary

Match Score: 75

** Alcami is seeking a Senior Scientist I specializing in Extractables and Leachables (E&L) testing to ensure patient safety and regulatory compliance for pharmaceutical products. The role requires extensive experience in mass spectrometry and chromatography, along with a solid background in GMP environments. **

Salary

Not specified; Not specified; Competitive salary and benefits package including medical, dental, vision, 401(k) with match

Skills & Requirements

Must-have

  • Extractables and Leachables testing
  • LC/MS method development
  • GC/MS volatile compound analysis
  • GMP documentation and compliance
  • Trace level analytical techniques

Nice-to-have

  • CDMO industry experience
  • Client interaction skills
  • Root cause analysis participation
  • Unknown peak identification
  • Regulatory expectation knowledge

Key Requirements

  • Bachelor's degree in Chemistry with 8+ years experience
  • 2+ years pharmaceutical drug product development under cGMP
  • Hands on experience with GC and HPLC method development
  • Expert knowledge of laboratory documentation systems
  • Proficiency with Microsoft Office suite

Work Rights

Not specified

Tailored Resume

Cover Letter