Scientist III - Analytical Chemist (Cleaning Verification) - FSP

About the role

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

We are looking to fill a Scientist III - Analytical Chemist position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in Rahway, NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off.

Qualifications

• BS in chemistry or a closely related field with at least 3-5 years of hands-on research experience
• MS in analytical chemistry or a closely related field with at least 1-2 years of hands-on research experience

Responsibilities

• Support cleaning verification and cleaning verification swab analysis for GMP manufacturing areas
• Experience with In-Process Control (IPC) Testing / Process Control Testing.
• Support cleaning validation and cleaning verification analysis for GMP manufacturing areas
• Data interpretation, processing, and reporting.
• Prepare GMP documentation including cleaning verification protocols and reports.
• Responsible for following safe laboratory practices and for maintaining the work area in a clean, orderly and safe manner
• General understanding of analytical method development and method validation

Required Skills and Experience

• Hands-on experience with chromatographic analysis using various LC
• General knowledge of separations science.
• Strong computer, scientific, and organizational skills
• Excellent communication (oral and written) and attention to detail
• Excellent organization to multi-task and manage multiple projects
• Ability to work independently and as part of a team.
• Good understanding of GMP compliance requirements and ALCOA documentation principles

Desired Skills and Experience

• Hands-on experience with chromatographic analysis using GC
• Experience with Empower chromatographic software and with analysis of drug formulations preferred
• Hands-on experience with method development and validation preferred

Experience with cleaning validation/verification preferred

• Skilled in method and instrument troubleshooting, specifically for LC and GC methods and systems
• Experience with KF moisture analysis