Scientist III - Cleaning Validation Analytical Chemist - FSP

Parexel; Dover (DE); On-site; USD 95,000 - 125,000; Full time

Job summary

Parexel is seeking a Scientist III - Cleaning Validation Analytical Chemist to join as a full-time employee of Parexel FSP on a long-term assignment onsite at a client location in Rahway, NJ. The role emphasizes hands-on analytical work in GMP environments and strict adherence to ALCOA documentation principles.

The ideal candidate has BS or MS in chemistry with relevant hands-on experience and will perform data interpretation, reporting, and preparation of GMP documentation, while ensuring safe

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 many 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 (UPLC/HPLC/GC

Separations science

Computer & data analysis

Communication

Organization

GMP ALCOA documentation

Analytical method development

Education

BS in chemistry or related field

MS in analytical chemistry or related field

Tools

Empower chromatographic software

FTIR

UV/VIS

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. T his 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.

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.