Senior Scientist – Extractables & Leachables (LCMS/GCMS)

NCBioImpact; Wilmington (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Alcami is a contract development and manufacturing organization headquartered in North Carolina with extensive expertise in extractables and leachables testing. The Sr.

Scientist III will lead LCMS/GCMS-based analyses and method development in a fast-paced environment, driving regulatory-compliant projects and client audits. The role emphasizes robust data interpretation, instrument maintenance, and cross-functional collaboration to support pharmaceutical product development and manufacturing at

Qualifications

• Bachelor’s degree in Chemistry with 15+ years of experience or Master’s degree with 11+ years of experience, or Ph.D. with 7+ years of experience required.
• 2+ years of experience in Pharmaceuticals drug product development under cGMP is required.
• CDMO experience is preferred.

Responsibilities

• Uses advanced skills in multiple techniques, to include assays (potencies, related substances), dissolution/drug release, residual solvents, elemental impurities, moisture content, identification and various other wet chemistry based measurements.
• Develops and validates methods, test procedures, protocols, and reports.
• Understands the theoretical basis of methods/experiments.
• Maintains strong knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
• Analyzes information for technical correctness and accuracy.

Skills

Mass spectrometry (LC/MS or GC/MS)

GMP documentation

cGMP knowledge

HPLC method development

Data analysis

Education

Bachelor’s degree in Chemistry with 15+ years of experience

Master’s degree with 11+ years of experience

Ph.D. with 7+ years of experience

Tools

Empower3

ProCal

Master Control

ELN

Job description

Alcami is a contract development and manufacturing organization headquartered in North Carolina with extensive expertise in extractables and leachables testing. The Sr.

Scientist III will lead LCMS/GCMS-based analyses and method development in a fast-paced environment, driving regulatory-compliant projects and client audits. The role emphasizes robust data interpretation, instrument maintenance, and cross-functional collaboration to support pharmaceutical product development and manufacturing at