Senior Scientist, Extractables & Leachables (LC/MS)

Alcami-5; Wilmington (NC); On-site; USD 140,000 - 180,000; Full time

Job summary

Alcami is seeking a Sr. Scientist III in Extractables & Leachables to drive analytical testing in a fast-paced pharmaceutical development environment. You will lead method development and validation projects, primarily using LCMS/GCMS methodologies, and ensure scientific rigor and regulatory compliance.

The role requires deep knowledge of instrumentation, data interpretation, and collaboration with clients during audits. On-site, first shift, with travel up to 5% as needed.

Qualifications

• Bachelor’s degree in Chemistry with significant industry experience (15+ years for Bachelor’s, 11+ for Master’s, 7+ for PhD).
• 2+ years of pharma drug product development experience under cGMP is required.
• CDMO experience is preferred.

Responsibilities

• Lead method development and validation projects, including assays and chromatography.
• Develop and validate procedures, test protocols, and reports.
• Understand the theoretical basis of methods and interpret data.
• Maintain instrumentation, equipment, and scientific methodologies for tasks.
• Interact with clients and support regulatory audits.
• Lead investigations and root cause analysis.
• Ensure cGMP compliance and safety in the lab.
• Write test procedures, protocols, and reports.

Skills

Verbal and written communication

Mass spectrometry

Data analysis

Regulatory knowledge (cGMP)

Laboratory instrumentation maintenance

Education

Bachelor's degree in Chemistry with 15+ years experience

Master's degree in Chemistry with 11+ years experience

PhD in Chemistry with 7+ years experience

2+ years of pharma drug product development under cGMP

Tools

Empower3

ProCal

Master Control

ELN

Job description

Alcami is seeking a Sr. Scientist III in Extractables & Leachables to drive analytical testing in a fast-paced pharmaceutical development environment. You will lead method development and validation projects, primarily using LCMS/GCMS methodologies, and ensure scientific rigor and regulatory compliance.

The role requires deep knowledge of instrumentation, data interpretation, and collaboration with clients during audits. On-site, first shift, with travel up to 5% as needed.