Senior Analytical Scientist – GMP, HPLC & Method Dev

Alcami-5; Morrisville (NC); On-site; USD 80,000 - 120,000; Full time

Job summary

Alcami is seeking a Scientist III to drive analytical testing in a fast-paced pharmaceutical development environment. You will perform routine and non-routine analyses using HPLC, TOC, UV, and particle size methods, supporting GMP review and regulatory compliance.

The role emphasizes method development/validation, data interpretation, and thorough documentation while ensuring safety and adherence to cGMP standards. On-site, with a 1st shift schedule as described.

Qualifications

• Hands-on experience performing compendial and raw material testing within a pharmaceutical, biotechnology, or CDMO environment.
• Strong knowledge of USP, EP, and JP compendial requirements and their application to pharmaceutical raw material and finished product testing.
• Excellent verbal and written communication and documentation skills required.
• Working knowledge of cGMP in a pharmaceutical or regulated environment preferred.

Responsibilities

• Develops and performs routine analytical analysis via HPLC, TOC, UV, and/or particle size based on various compendia.
• Performs GMP review of solutions and wet chemical analyses and chromatography.
• Performs one or more of the following techniques: residual solvents, assays (potencies, related substances), dissolution, elemental impurities, moisture content, identification, and various other wet chemistry-based measurements.
• Evaluates and interprets generated data.
• Writes test procedures, protocols, and reports.
• Maintains working knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.

Skills

Analytical testing

Data interpretation

Quality systems

Documentation

Problem solving

Education

Associate’s degree

Bachelor’s degree

Master’s degree

PhD

Tools

Empower3

ProCal

Master Control

ELN

Job description

Alcami is seeking a Scientist III to drive analytical testing in a fast-paced pharmaceutical development environment. You will perform routine and non-routine analyses using HPLC, TOC, UV, and particle size methods, supporting GMP review and regulatory compliance.

The role emphasizes method development/validation, data interpretation, and thorough documentation while ensuring safety and adherence to cGMP standards. On-site, with a 1st shift schedule as described.