Drug Product Analytical Chemist – GMP & HPLC

Parexel; Cheyenne (WY); On-site; USD 85,000 - 110,000; Full time

Job summary

Parexel is seeking a Scientist 2 or 3 - Analytical Chemist (Drug Product) for a long-term assignment onsite at Rahway, NJ. The role is within Parexel FSP and supports drug product stability testing in a regulated lab.

The candidate will perform routine and stability analyses, SOP authoring, and data interpretation in a GMP environment, requiring strong documentation and collaborative problem-solving skills.

Qualifications

• B.S./M.S. in Chemistry, Biochemistry, Engineering, or a related discipline.
• Scientist 2 - B.S. with1-2years of relevant experience
• Scientist 3 - B.S. with 3-5 years of relevant experience or M.S. with 1-2 years of relevant experience
• Experience with GMP analysis using HPLC/UPLC including assay/impurity/etc., troubleshooting and data processing interpretation/analysis
• Routine testing, data integrity assessments, investigative report authoring, and/or sample management responsibilities
• Strong computer, scientific, and organizational skills
• Clear communicator who speaks up about problems and improvement ideas
• Able to manage multiple ongoing projects
• Ability to work independently and as part of a team
• Self-motivation, efficiency, adaptability, and a positive attitude
• Experience with Dissolution, Karl Fischer (KF), moisture testing and other wet chemistry skills
• Empower software
• Analysis of drug products
• Good understanding of cGMP compliance requirements and ALCOA documentation principle

Responsibilities

• In the drug product registration stability testing lab, you’ll perform routine and stability sample analysis, SOP authoring, and day-to-day problem solving while contributing to new technologies and continuous improvement measures for optimized lab operations and other testing requirements.
• Apply analytical characterization technologies and compliance principles to drive method robustness and high-quality stability data supporting late-stage pharmaceutical drug product development and commercialization.
• The ideal candidate is proactive, collaborative, and thrives in a compliance-focused environment.

Skills

GMP analysis

HPLC/UPLC

Data interpretation

Documentation/ALCOA

Project management

Independent and team work

Communication

Empower software

Education

BS in Chemistry/related discipline

MS in Chemistry/related discipline

Tools

Empower software

Job description

Parexel is seeking a Scientist 2 or 3 - Analytical Chemist (Drug Product) for a long-term assignment onsite at Rahway, NJ. The role is within Parexel FSP and supports drug product stability testing in a regulated lab.

The candidate will perform routine and stability analyses, SOP authoring, and data interpretation in a GMP environment, requiring strong documentation and collaborative problem-solving skills.