Senior Chemist, Raw Materials – GMP & Method Transfer

MedPharm

Durham (NC)

On-site

USD 90,000 - 130,000

Full time

3 days ago
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Job summary

MedPharm in Durham, NC, seeks a Chemist III/Sr. Chemist for Raw Materials to perform advanced analytical testing (HPLC, GC, FTIR, UV-Vis) and ensure GMP compliance, data review, and documentation in a CDMO setting.

Strong communication with internal and external clients is preferred. Responsibilities include scheduling laboratory work, reviewing data for regulatory compliance, leading method verification/transfer, overseeing equipment calibration, and mentoring junior analysts while

Qualifications

  • BS/BA in a scientific discipline required.
  • 5–8 years analytical chemistry experience in a cGMP/GLP environment.
  • Experience in CRO/CDMO settings is preferred.
  • Experience with USP/EP/JP monographs and laboratory data review.

Responsibilities

  • Schedule QC lab workload to meet release testing timelines.
  • Review data for compliance with specifications and regulatory requirements.
  • Lead method verification, validation, and transfer for incoming raw materials.
  • Oversee calibration, maintenance, and troubleshooting of lab equipment.
  • Provide technical guidance to junior analysts and collaborate with QA/Manufacturing.
  • Author and review GMP documentation including SOPs, deviations, CAPAs.

Skills

Analytical chemistry
cGMP knowledge
Data review
Communication
Time management
Self-directed
Team collaboration

Education

Bachelor's degree in a scientific discipline

Tools

Empower
LIMS
Microsoft Office

Job description

MedPharm in Durham, NC, seeks a Chemist III/Sr. Chemist for Raw Materials to perform advanced analytical testing (HPLC, GC, FTIR, UV-Vis) and ensure GMP compliance, data review, and documentation in a CDMO setting.

Strong communication with internal and external clients is preferred. Responsibilities include scheduling laboratory work, reviewing data for regulatory compliance, leading method verification/transfer, overseeing equipment calibration, and mentoring junior analysts while

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