Senior Analytical Chemist – QC, Validation, Data Integrity

Wilmington PharmaTech Company; Newark (DE); On-site; USD 90,000 - 130,000; Full time

Job summary

Wilmington PharmaTech seeks an experienced Senior Analytical Chemist to support QC analytical activities for API development, clinical supply, and commercial manufacturing. You will execute, review, and oversee analytical testing in accordance with cGMP and data integrity requirements, serving as a technical leader in the QC lab.

Responsibilities include method validation/transfer, investigations of OOS/OOT, CAPA support, and stability program participation.

Qualifications

• Experience in Quality Control or analytical laboratories in pharma, API, or CDMO settings.
• Strong understanding of cGMP and data integrity principles.
• Excellent written and verbal communication for cross-functional teams and regulatory audits.

Responsibilities

• Perform and supervise routine QC testing of materials and products using established methods.
• Operate, maintain, and troubleshoot HPLC, GC, KF, UV, IR instruments.
• Review analytical data, chromatograms, and results for accuracy and compliance with cGMP.
• Lead OOS/OOT investigations and support deviation investigations.
• Support method validation, transfer, and lifecycle management of analytical methods.
• Assist with stability testing programs and data reporting.

Skills

Analytical chemistry proficiency

Documentation & compliance

Education

Bachelors degree in Chemistry

Advanced degree preferred

Tools

HPLC

GC

KF

UV

IR

Job description

Wilmington PharmaTech seeks an experienced Senior Analytical Chemist to support QC analytical activities for API development, clinical supply, and commercial manufacturing. You will execute, review, and oversee analytical testing in accordance with cGMP and data integrity requirements, serving as a technical leader in the QC lab.

Responsibilities include method validation/transfer, investigations of OOS/OOT, CAPA support, and stability program participation.