Scientist III - Cleaning Validation Analytical Chemist

Regulatory Jobs; Rahway (NJ); On-site; USD 95,000 - 125,000; Full time

Job summary

Parexel, a global leader in clinical development, is seeking a Scientist III - Cleaning Validation Analytical Chemist to join the FSP team onsite at a client site in Rahway, NJ. This full-time role offers comprehensive benefits, paid holidays and PTO, with no US sponsorship.

The position emphasizes GMP-compliant analytical work and hands-on chromatography using UPLC/HPLC/GC. The ideal candidate will have a BS with 3–5 years or MS with 1–2 years of related research, strong data interpretation

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
• Hands-on experience with chromatographic analysis using UPLC, HPLC, and GC techniques
• Strong GMP knowledge and ALCOA documentation practices
• Excellent communication and ability to work both independently and in a team
• Experience with Empower chromatographic software and analysis of drug formulations preferred
• FTIR and UV/VIS analysis preferred
• Experience with cleaning validation/verification preferred
• LC and GC method troubleshooting experience preferred

Responsibilities

• Support cleaning validation and cleaning verification analysis for GMP manufacturing areas
• Conduct raw materials release testing using varied methodologies and techniques in a GMP laboratory
• 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

Skills

Chromatographic analysis

GMP compliance

ALCOA documentation

Data interpretation

Independent work

Communication skills

Method development knowledge

Team collaboration

Education

BS in chemistry

MS in analytical chemistry

Tools

Empower software

FTIR

UV/VIS

HPLC/UPLC

GC

Job description

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 - Cleaning Validation 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 validation and cleaning verification analysis for GMP manufacturing areas
• Conduct raw materials release testing using myriads of methodologies and techniques in a GMP laboratory
• 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

Required Skills and Experience

• Hands-on experience with chromatographic analysis using various UPLC, HPLC, 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
• General understanding of analytical method development and method validation

Desired Skills and Experience

• Experience with Empower chromatographic software and with analysis of drug formulations preferred
• Hand-on experience with FTIR and UV/VIS analysis 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.