Scientist III - Analytical Chemist (Drug Substance Analysis) - FSP
About The Position
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. 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.
Requirements
- B.S. with 3-5 years of experience; M.S. with 1-2 years of 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
- Ability to work independently and as part of a team, displaying self-motivation, adaptability, and a positive attitude
Nice To Haves
- Empower software
- Analysis of drug product and drug substance
Responsibilities
- Perform routine and stability sample analysis
- SOP authoring
- Day-to-day problem solving
- Contribute to new technologies and continuous improvement measures for optimized lab operations and other testing requirements
- 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
- GMP release
- Stability testing
- Data processing, interpretation and reporting
Benefits
- full benefits
- sick time
- 401K
- paid holidays
- paid time off
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
