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

Parexel International; New Jersey; On-site; USD 90,000 - 130,000; Full time

Job summary

Parexel FSP is seeking a Scientist 3: Analytical Chemist for Drug Substance Analysis, full-time, onsite in Rahway, NJ. You will perform stability and routine analyses in a GMP-lab, contribute to SOPs, and support method development and validation to improve data quality.

The ideal candidate holds a BS/MS in chemistry or life sciences and 3–5 years (BS) or 1–2 years (MS) in GMP environments, with strong attention to detail, documentation, and teamwork to meet project timelines.

Qualifications

• GMP laboratory experience required
• Experience with chromatographic analysis
• Analytical method development and validation
• Stability testing and GMP release experience

Responsibilities

• Perform routine and stability sample analyses in a GMP lab
• SOP authoring and day-to-day problem solving
• Contribute to new technologies and lab improvements
• Apply analytical characterization to drive method robustness
• Support drug product development and commercialization data

Skills

UPLC/HPLC/GC

GDP compliance

Separation science

Method development

FTIR

KF

Dissolution

Documentation

Communication

Multitasking

GMP release

Stability testing

Data interpretation

Teamwork

Independence

Education

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

Tools

Analytical software

Job description

We are looking to fill aScientist3 -AnalyticalChemist(Drug Substance Analysis)position working asa full-time employee of Parexel FSP on long-term assignmentonsite at one of our clientslocatedinRahway, 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
• Desired Skills and Experience
  • Empower software
  • Analysis of drug product and drug substance

Overview

In the drug product registration stability testing lab,you’llperform routine and stability sample analysis, SOP authoring, and day-to-day problem solving while contributing tonew technologiesand continuous improvement measures for optimized lab operations and other testing requirements.You’llapply 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.