Senior Analytical Chemist, GMP Raw Materials

MedPharm Ltd; Durham (NC); On-site; USD 85,000 - 130,000; Full time

Job summary

MedPharm Ltd. in Durham, NC seeks a Chemist III/Sr. Chemist Raw Materials to ensure testing, data review, and documentation meet GMP, USP/EP/JP standards in a CDMO environment.

The role emphasizes signal integrity, cross‑functional communication, and regulatory compliance. The candidate will lead method verification, validation, and transfers for incoming raw materials, oversee lab equipment, and coordinate with external laboratories.

Qualifications

• Minimum BA or BS in a scientific discipline.
• 5–8 years of analytical chemistry in a cGMP/GLP environment.
• Experience at a CDMO or pharmaceutical company preferred.
• Experience with USP/EP/JP monographs.

Responsibilities

• Schedule QC laboratory Raw Materials workload to meet manufacturing release testing schedules, stability pull dates and timelines.
• Monitor weekly laboratory and data review activities for accuracy and track hours needed for completion of tasks.
• Oversight for review of QC and Raw Material data for compliance with specifications and regulatory requirements
• Interact with third party laboratories for microbial and analytical testing of raw materials
• Generate and/or review shipping paperwork for third part testing and prepare samples for shipment.
• Create purchase requisitions for lab supplies and third-party testing
• Perform weekly laboratory audit inspections
• Perform sampling of raw materials as needed
• Review third party laboratory investigations and protocols.
• Execute intermediate to advanced chemical and instrumental testing of raw materials using HPLC, GC, FTIR, UV-Vis, Karl Fischer titration, and wet chemistry.
• Ensure all testing meets compendial standards (USP/EP/JP) and regulatory expectations. Conduct peer reviews of data, Certificates of Analysis (COAs), and laboratory logbooks.
• Author and review GMP documentation including Standard Operating Procedures (SOPs), protocols, deviations, Corrective and Preventive Actions (CAPAs), and change controls.
• Provide technical guidance to junior analysts. Lead method verification, validation, and method transfer activities for incoming raw materials.
• Oversee the calibration, maintenance, and troubleshooting of laboratory equipment.
• Other duties as assigned

Skills

cGMP knowledge

Data review

Analytical chemistry

Excellent communication

GMP/GLP familiarity

Education

BA or BS in a scientific discipline

Tools

HPLC

GC

FTIR

Karl Fischer

LIMS

Empower

UV-Vis

Job description

MedPharm Ltd. in Durham, NC seeks a Chemist III/Sr. Chemist Raw Materials to ensure testing, data review, and documentation meet GMP, USP/EP/JP standards in a CDMO environment.

The role emphasizes signal integrity, cross‑functional communication, and regulatory compliance. The candidate will lead method verification, validation, and transfers for incoming raw materials, oversee lab equipment, and coordinate with external laboratories.