Chemist

Work Location: Plymouth County, MA

Summary:

Seeking a Chemist to perform advanced chemical and physical testing, support method development and validation, and ensure compliance with regulatory standards in a laboratory environment. This role involves technical leadership, troubleshooting, and continuous improvement initiatives.

Responsibilities:

• Conduct and oversee physical, chemical, and microbiological testing for raw materials, in-process materials, finished products, and stability studies.
• Lead and support analytical method development, validation, qualification, and verification in accordance with regulatory and internal standards.
• Utilize and troubleshoot analytical instrumentation such as HPLC, GC, UV/VIS, IR, TOC, and AA, while providing training to junior staff.
• Review and approve analytical data to ensure accuracy, completeness, and compliance with cGMP documentation requirements.
• Assist in the creation and review of Standard Operating Procedures, test methods, and validation protocols and reports.
• Maintain laboratory compliance with safety, calibration, and maintenance requirements, ensuring a clean and organized workspace.
• Collaborate with cross-functional teams to support investigations, deviations, out-of-specification results, and continuous improvement projects.
• Mentor and train less experienced chemists and laboratory technicians as needed.

Qualifications:

• Bachelor’s or Master’s degree in Chemistry or a related scientific discipline.
• Minimum of 5 years of industry experience in pharmaceutical, chemical, or regulated environments performing analytical chemistry, method development, validation, and release testing.
• Expertise with cGMP, GLP, USP/NF testing, and laboratory instrumentation (HPLC, GC, UV/VIS, IR, TOC, etc.).
• Strong understanding of regulatory expectations (FDA, ICH) and quality systems in a laboratory setting.
• Excellent problem-solving skills, attention to detail, and ability to manage multiple priorities in a fast-paced environment.
• Effective written and verbal communication skills, with experience in data interpretation and technical reporting.

Published Category: Analytical & Process Development