Senior Analytical Chemist, Drug Product — GMP

Parexel; Santa Fe (NM); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Full benefits

Sick time

401K

Paid holidays

Paid time off

Job summary

Parexel is seeking a Scientist 2 or 3 – Analytical Chemist (Drug Product) for a full-time, on-site role at a client location in Rahway, NJ. The position emphasizes GMP-compliant analysis, method robustness, and data integrity in drug product stability testing.

Ideal candidates have a BS/MS in chemistry or related fields with relevant experience in HPLC/UPLC and oversight of analysis, reporting, and SOP development within a regulated environment.

Qualifications

• BS/MS in Chemistry, Biochemistry, Engineering, or related field.
• Scientist 2 requires BS with 1-2 years of relevant experience; Scientist 3 requires BS with 3-5 years or MS with 1-2 years.
• Experience with GMP analysis using HPLC/UPLC for assay/impurity, Troubleshooting and data processing interpretation/analysis.
• Routine testing, data integrity assessments, investigative report writing, and/or sample management responsibilities.
• Strong computer, scientific, and organizational skills.
• Clear communicator who speaks up about problems and ideas for improvement.
• 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, KF, moisture testing and other wet chemistry skills.
• Empower software
• Analysis of drug products
• Good understanding of cGMP compliance requirements and ALCOA documentation principles

Responsibilities

• In the drug product registration stability testing lab, perform routine and stability sample analysis, SOP authors, and day-to-day problem solving.
• Contribute 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.
• Support late-stage pharmaceutical drug product development and commercialization.
• Be proactive, collaborative, and thrive in a compliance-focused environment.

Skills

GMP analysis (HPLC/UPLC)

Data interpretation

Routine testing

Investigation reporting

Sample management

Strong communication

Multi-project management

Independent and team work

Self-motivation

Adaptability

Education

B.S./M.S. in Chemistry/Biochemistry/Engineering or related field

Tools

Empower

Job description

Parexel is seeking a Scientist 2 or 3 – Analytical Chemist (Drug Product) for a full-time, on-site role at a client location in Rahway, NJ. The position emphasizes GMP-compliant analysis, method robustness, and data integrity in drug product stability testing.

Ideal candidates have a BS/MS in chemistry or related fields with relevant experience in HPLC/UPLC and oversight of analysis, reporting, and SOP development within a regulated environment.