Scientist III - Analytical Chemist (Drug Substance Analysis) - FSP

Parexel; Washington (District of Columbia); On-site; USD 95,000 - 135,000; Full time

Job summary

Parexel is seeking a Scientist 3 - Analytical Chemist (Drug Substance Analysis) to join our FSP on a long-term assignment in Rahway, NJ. The role is full-time, onsite, with comprehensive benefits and no sponsorship. You will perform routine stability testing, SOP work, and contribute to method development and validation in a GMP setting.

The ideal candidate has a B.S./M.S. in a life science and hands-on chromatographic experience, with strong documentation and communication skills to support

Qualifications

• B.S./M.S. in Chemistry, Chemical Engineering, Biochemistry, Biology or life sciences with GMP lab experience.
• Scientist 3: B.S. 3–5 yrs or M.S. 1–2 yrs in GMP lab setting.
• Hands-on chromatographic analysis using UPLC, HPLC and GC with troubleshooting.
• Adheres to GDP standards with compliant documentation.
• Knowledge of separations science and analytical method development/validation.
• Experience with FTIR, KF and dissolution testing; strong data handling.
• Excellent written and oral communication; highly organized and detail oriented.

Responsibilities

• Perform routine and stability sample analysis in a drug substance lab.
• Author SOPs and support day-to-day problem solving.
• Drive method robustness and high-quality stability data.
• Contribute to method development and validation activities.
• Work independently and in teams; maintain compliance and data integrity.

Skills

Chromatographic analysis

UPLC/HPLC/GC

GMP documentation

Method development

FTIR/KF/Dissolution

Data processing

Technical communication

Multi-tasking

Team collaboration

Education

B.S./M.S. in Chemistry or related life sciences

Tools

Empower software

Job description

We are looking to fill a Scientist 3 - Analytical Chemist (Drug Substance Analysis) 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 - B.S./M.S. in Chemistry, Chemical Engineering, Biochemistry, Biology or similar life sciences and relevant years of experience as listed below in a GMP laboratory environment.

Scientist 3 - B.S. with 3-5 years of experience; M.S. with 1-2 years of experience

Required Skills and Experience

• Hands-on experience with chromatographic analysis using various UPLC, HPLC and GC techniques, including method and instrument troubleshooting
• Consistently adheres to GDP standards with accurate, compliant documentation
• General knowledge of separations science
• General understanding of analytical method development and method validation
• Hands-on experience with FTIR, KF and Dissolution
• Strong computer, scientific, and organizational skills
• Excellent communication (oral and written) and attention to detail
• Excellent organization to multi-task and manage multiple ongoing projects in parallel including GMP release, stability testing along with data processing, interpretation and reporting
• Ability to work independently and as part of a team, displaying self-motivation, adaptability, and a positive attitude
• undefined Desired Skills and Experience Empower softwareAnalysis of drug product and drug substance

Overview

In the drug product registration stability testing lab, you’ll perform routine and stability sample analysis, SOP authoring, and day-to-day problem solving while contributing to new technologies and continuous improvement measures for optimized lab operations and other testing requirements. You’ll apply analytical characterization technologies and compliance principles to drive method robustness and high-quality stability data supporting late-stage pharmaceutical drug product development and commercialization. The ideal candidate is proactive, collaborative, and thrives in a compliance-focused environment.

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.