Chemist

Work Location: Plymouth County, Massachusetts

Summary:

Seeking a Chemist to lead and perform advanced chemical and physical testing, supporting the release of raw materials, packaging components, drug substances, and drug products. This role serves as a technical expert in the laboratory, supporting method development, validation, troubleshooting, and continuous improvement to ensure compliance with cGMP and regulatory standards.

Responsibilities:

• Conduct and oversee physical, chemical, and microbiological testing for raw materials, in-process materials, finished products, stability studies, and special projects.
• Lead and support analytical method development, validation, qualification, and verification in line with regulatory and internal standards.
• Utilize and provide expertise in analytical instrumentation such as HPLC, GC, UV/VIS, IR, TOC, and AA, including troubleshooting and training junior staff.
• Review and approve analytical data to ensure accuracy, completeness, and compliance with cGMP documentation requirements.
• Assist in drafting and reviewing SOPs, test methods, and validation protocols and reports.
• Maintain laboratory compliance with safety, calibration, and maintenance requirements, ensuring a clean and organized environment.
• Collaborate with cross-functional teams to support investigations, deviations, out-of-specification results, and continuous improvement initiatives.
• Mentor and train less experienced chemists and laboratory technicians.

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