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

Parexel; Helena (MT); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Benefits package

401K

Paid holidays

Sick time

Paid time off

Job summary

Parexel is seeking a Scientist 3 - Analytical Chemist (Drug Substance Analysis) for a full-time Parexel FSP assignment onsite at a client site in Rahway, NJ. In this GMP laboratory role you will perform routine and stability sample analysis, author SOPs, and support method development and validation, collaborating to ensure compliant, high-quality stability data for late-stage development.

Candidates should hold a B.S./M.S.

Qualifications

• B.S./M.S. in Chemistry or life sciences with GMP lab experience.
• Scientist 3: B.S. with 3–5 years or M.S. with 1–2 years.
• Hands-on chromatographic analysis with UPLC/HPLC/GC; troubleshoot methods.
• GDP standards, compliant documentation.
• General knowledge of separations science; method validation.

Responsibilities

• Perform routine and stability sample analysis in GMP lab.
• Author SOPs and contribute to method development and validation.
• Support data processing, interpretation, and reporting of stability data.
• Collaborate across teams to ensure high-quality results for late-stage development.

Skills

Chromatography

GMP Documentation

Separations Science

Method Development

FTIR/Dissolution

Empower Software

Communication skills

Independence/Teamwork

Drug Substance Analysis

Compliance

Education

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

Tools

UPLC/HPLC/GC equipment

FTIR

KF

Dissolution testing

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!

#LI-DK1

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.