Scientist III - Cleaning Validation Analytical Chemist - FSP

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. This position does not offer any sponsorship.

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

• Conduct raw materials release testing using myriad of methodologies and techniques in a GMP laboratory

• Support cleaning validation and cleaning verification analysis for GMP manufacturing areas

• Data interpretation, processing, and reporting.

• Prepare GMP documentation including analytical reports and certification of analyses

• 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 and GC techniques.

• 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

• Experience with Empower chromatographic software and with analysis of drug formulations preferred

• Hands-on experience with method development and validation preferred
  Experience with raw materials release per USP/NF preferred.

• Experience with cleaning validation/verification preferred

• Skilled in method and instrument troubleshooting, specifically for LC and GC methods and systems

About Parexel

Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement.

Come join us!

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EEO Disclaimer
Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.