Analytical Scientist / Senior Analytical Scientist
$70,000–$90,000 year
On-sitePearl River, New York, United States
Job Summary
Develop, optimize, validate, and transfer analytical methods for assay, related substances, dissolution, cleaning validation, and stability testing. Perform analytical testing of APIs, raw materials, in-process samples, and finished products using HPLC, UPLC, GC, UV-Visible Spectroscopy, FTIR, and particle size analysis instrumentation. Execute stability studies, monitor investigations involving OOS, OOT, deviations, and CAPAs, and prepare SOPs, specifications, and laboratory documentation. Collaborate with Formulation Development, Quality Assurance, Regulatory Affairs, and Manufacturing teams while mentoring junior analysts. Requires Bachelor's degree in Chemistry or related field with 5+ years of pharmaceutical laboratory experience; Master's preferred.
Required Qualifications
- Bachelor's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Pharmacy, or a related scientific discipline
- Master's degree
- Analytical Scientist: approximately 5+ years of pharmaceutical laboratory experience
- Senior Analytical Scientist: approximately 8–12+ years of pharmaceutical analytical development and/or quality control experience
- Experience supporting injectable, or oral liquid products
- Strong working knowledge of Instrumentation
- Strong working knowledge of HPLC, UPLC, and GC systems
- Strong working knowledge of UV-Visible Spectrophotometer
- Strong working knowledge of FTIR Spectroscopy
- Strong working knowledge of Dissolution Testing (USP Apparatus I & II)
- Strong working knowledge of Particle Size Analysis (Malvern Mastersizer and Zetasizer)
- Strong working knowledge of Karl Fischer Titration
- Strong working knowledge of Brookfield Viscometer
- Strong working knowledge of Empower 3
- Strong working knowledge of LabSolutions
- Strong working knowledge of SAP
- Strong working knowledge of Microsoft Office Suite
- Strong working knowledge of FDA Regulations
- Strong working knowledge of ICH Guidelines
- Strong working knowledge of USP Requirements
- Strong working knowledge of cGMP
- Strong working knowledge of cGLP
- Strong working knowledge of GDP
- Strong working knowledge of Quality by Design (QbD)
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.