Scientist III - Analytical Chemist (Drug Substance Analysis) - FSP
Parexel
Summary
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.
Job description
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.
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
Requirements
- B.S./M.S. in Chemistry, Chemical Engineering, Biochemistry, Biology or similar life sciences
- B.S. with 3-5 years of experience; M.S. with 1-2 years of experience in a GMP laboratory environment
- 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
Benefits
- Full Benefits
- Sick Time
- 401K
- Paid Holidays
- Paid Time Off
Company overview
Parexel is one of the world's largest and most prominent contract research organizations (CROs), providing comprehensive clinical research services to pharmaceutical and biotechnology companies globally. Founded in 1982 and headquartered in Raleigh, North Carolina, Parexel operates with a global workforce of over 24,000 professionals across 84+ facilities in 49 countries. The company specializes in managing the full spectrum of clinical trials from Phase I to IV across diverse therapeutic areas including neuroscience, oncology, infectious diseases, hematology, and general medicine. Parexel offers end-to-end solutions encompassing clinical trial management, regulatory strategy, data management, biostatistics, pharmacovigilance, medical communications, and market access consulting. With a strong track record spanning over 40 years, Parexel has established itself as a trusted partner for both established pharmaceutical leaders and emerging biotech innovators, helping accelerate drug development and bring life-saving treatments to patients faster through its patient-centric approach and operational excellence.