Scientist III - Cleaning Validation Analytical Chemist - FSP

Parexel International; New Jersey; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Benefits package

Sick time

401K

Paid holidays

Paid time off

Job summary

Parexel seeks a Scientist III - Cleaning Validation Analytical Chemist for a full-time role on a long-term assignment onsite at a client location in Rahway, NJ. The position includes full benefits, sick time, 401(k), holidays, and PTO, with no sponsorship offered.

You will perform chromatographic analyses (UPLC, HPLC, GC), support validation activities, and prepare reports while ensuring ALCOA-compliant documentation and safe lab practices.

Qualifications

• BS in chemistry or closely related field with 3–5 years of hands-on research experience.
• MS in analytical chemistry or closely related field with 1–2 years of hands-on research experience.
• Hands-on chromatographic analysis using UPLC, HPLC, and GC techniques.
• General knowledge of separations science.
• Strong computer, scientific, and organizational skills.
• Excellent oral and written communication and attention to detail.
• Excellent organization to multi-task and manage multiple projects.
• Ability to work independently and in a team.
• Good understanding of GMP requirements and ALCOA documentation principles.
• General understanding of analytical method development and method validation.

Responsibilities

• Support cleaning validation and cleaning verification analysis for GMP manufacturing areas.
• Conduct raw materials release testing using various methodologies in a GMP laboratory.
• Data interpretation, processing, and reporting.
• Prepare GMP documentation including analytical reports and certificates of analyses.
• Maintain safe laboratory practices and a clean, orderly work area.

Skills

Chromatography

Separations science

Computer skills

Organizational skills

Communication skills

Attention to detail

Multitasking

Teamwork

GMP compliance

Method development

Method validation

Education

BS in chemistry / related field

MS in analytical chemistry

Tools

Empower chromatographic software

FTIR

UV/Vis

GC & LC instrumentation

Job description

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.