Analytical Chemist (Drug Product) – GMP & Stability

Parexel; Indianapolis (IN); On-site; USD 85,000 - 110,000; Full time

Job summary

Parexel is seeking a Scientist 2 or 3 - Analytical Chemist (Drug Product) to work on long-term assignments onsite at our client in Rahway, NJ. The role emphasizes stability testing, SOP authoring, and rigorous data quality within a compliance-driven environment.

The ideal candidate will have a strong background in GMP analytical methods, HPLC/UPLC, and the ability to manage multiple projects while collaborating across teams at Parexel FSP.

Qualifications

• B.S./M.S. in Chemistry, Biochemistry, Engineering, or a related discipline.
• Scientist 2: BS with 1-2 years of relevant experience.
• Scientist 3: BS with 3-5 years or MS with 1-2 years of relevant experience.
• Experience with GMP analysis using HPLC/UPLC including assay and impurity analysis, and data processing.
• Routine testing, data integrity assessments, investigative report authoring, and sample management.
• 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, perform routine and stability sample analysis.
• Author SOPs and day-to-day problem solving while contributing to new technologies.
• Support continuous improvement measures for optimized lab operations and testing requirements.

Skills

HPLC/UPLC

GMP compliance

Data analysis

Investigation reporting

Sample management

Computer skills

Communication skills

Project management

Teamwork

Adaptability

Education

BS/MS in Chemistry or related field

Tools

Empower software

Job description

Parexel is seeking a Scientist 2 or 3 - Analytical Chemist (Drug Product) to work on long-term assignments onsite at our client in Rahway, NJ. The role emphasizes stability testing, SOP authoring, and rigorous data quality within a compliance-driven environment.

The ideal candidate will have a strong background in GMP analytical methods, HPLC/UPLC, and the ability to manage multiple projects while collaborating across teams at Parexel FSP.