Analytical Scientist III: Compendial Raw Material Testing

Alcami Corporation; Morrisville (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Alcami Corporation is seeking a Scientist III to execute analytical testing (HPLC, dissolution, GC) and support compendial and raw material testing for pharmaceutical development and manufacturing. The role covers method development/validation, data interpretation, and report writing.

The candidate will work on 1st shift weekend coverage and be involved in maintaining GMP-compliant practices. Responsibilities include GMP reviews, hazardous waste handling, and training in cGMP.

Qualifications

• Demonstrated hands-on experience performing compendial and raw material testing in pharma, biotech, or CDMO settings.
• Strong knowledge of USP, EP, and JP compendial requirements and their application.
• Excellent verbal and written communication and documentation skills.

Responsibilities

• Develops and performs routine analytical analysis via HPLC, TOC, UV, and particle size using compendia.
• Performs GMP review of solutions and wet chemical analyses and chromatography.
• Executes techniques such as residual solvents, assays, dissolution, impurities, moisture, identification, and related measurements.
• Evaluates and interprets generated data for accuracy and relevance.
• Analyzes information for technical correctness and accuracy.
• Understands the theoretical basis of methods and experiments.
• Solves problems requiring evaluation of identifiable factors.
• Writes test procedures, protocols, and reports.
• Maintains knowledge of instrumentation and methodologies.
• Assists in hazardous waste handling and routine lab housekeeping.
• Uses laboratory software packages (Empower3, ProCal, Master Control, ELN) effectively.
• Maintains a safe, clean, and organized work environment and adheres to safety protocols.
• Safely handles potent compounds.
• Completes RCRA and cGMP training and related Alcami requirements.
• Ensures timely completion and compliance with company training requirements.

Skills

HPLC

Dissolution

GC

UV-Vis

Titrations

Compendial testing

Data interpretation

Problem solving

Documentation

cGMP knowledge

Safety awareness

Laboratory knowledge

Microsoft Office

Education

Associate's degree + 16+ years experience

Bachelor's degree + 6+ years experience

Master's degree + 2+ years experience

PhD + 0+ year experience

Tools

Empower3

ProCal

Master Control

ELN

Microsoft Office

Job description

Alcami Corporation is seeking a Scientist III to execute analytical testing (HPLC, dissolution, GC) and support compendial and raw material testing for pharmaceutical development and manufacturing. The role covers method development/validation, data interpretation, and report writing.

The candidate will work on 1st shift weekend coverage and be involved in maintaining GMP-compliant practices. Responsibilities include GMP reviews, hazardous waste handling, and training in cGMP.