Sr. Analytical Chemists – B.S., M.S, Ph.D.

Wilmington PharmaTech; Newark, Northern (DE, KY); Hybrid; 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

Sr. Analytical Chemists – B.S., M.S, Ph.D.

Wilmington PharmaTech (WPT) is seeking an experienced Senior Analytical Chemist to support Quality Control (QC) analytical activities for API development, clinical supply, and commercial manufacturing. This role is responsible for executing, reviewing, and overseeing analytical testing in compliance with cGMP requirements while supporting investigations, method validation, and continuous improvement initiatives. The successful candidate will serve as a technical leader within the QC laboratory, ensuring data integrity, regulatory compliance, and reliable analytical support for manufacturing operations. This position reports to senior leadership within Quality Control.

Responsibilities

The Role

01

QC Analytical Testing & Laboratory Execution

Routine QC Testing: Perform and oversee routine analytical testing of raw materials, in-process samples, APIs, and stability samples using established methods.

Instrumentation Expertise: Operate, maintain, and troubleshoot analytical instrumentation including HPLC, GC, KF, UV, IR, and other relevant techniques.

Data Review & Approval: Review analytical data, chromatograms, and test results to ensure accuracy, completeness, and compliance with cGMP and data integrity requirements.

Laboratory Operations: Ensure analytical testing is executed in accordance with approved methods, SOPs, and safety procedures.

02

GMP Compliance & Investigations

OOS/OOT Investigations: Lead and support investigations related to out-of-specification and out-of-trend results, including root cause analysis and documentation.

Deviation Support: Participate in deviation investigations related to analytical testing and laboratory operations.

CAPA Implementation: Support the development and execution of corrective and preventive actions associated with QC laboratory activities.

Data Integrity: Ensure adherence to data integrity principles (ALCOA+) and regulatory expectations for electronic and paper-based records.

03

Method Validation, Transfer & Lifecycle Support

Method Validation: Execute and support analytical method validation, verification, and revalidation activities in accordance with regulatory guidelines.

Method Transfer: Support the transfer of analytical methods between development and internal QC laboratories

Method Maintenance: Support lifecycle management of analytical methods, including troubleshooting and continuous improvement.

Stability Programs: Support stability testing programs, including sample analysis, data review, and reporting.

KEY REQUIREMENTS

The Candidate

Education: Bachelor’s degree or higher in Chemistry, Analytical Chemistry, or a related scientific discipline; an advanced degree is preferred.

Experience: 0-5+ years of experience in Quality Control or analytical laboratories within pharmaceutical, API, or CDMO environments.

Instrumentation Knowledge: Demonstrated proficiency with chromatographic and spectroscopic techniques, including HPLC and GC.

Communication: Excellent written and verbal communication skills, with the ability to clearly document analytical work and interact effectively with cross-functional teams, auditors, and regulatory inspectors