- Perform Extractables & Leachables (E&L;) analysis using Ion Chromatography (IC) or High-Performance Liquid Chromatography (HPLC) or Liquid Chromatography-Mass Spectroscopy (LCMS) or Gas Chromatography (GC-MS) for pharmaceutical packaging, drug delivery systems, and medical devices.
- Develop, optimize, and validate methods for the detection and quantification of E&L; compounds.
- Analyze and interpret analysis data to identify and assess extractables and leachables, preparing detailed reports on findings.
- Conduct routine maintenance, troubleshooting, and calibration of instruments to ensure optimal performance.
- Prepare and review Standard Operating Procedures (SOPs), study protocols, and validation reports related to E&L; studies.
- Collaborate with cross-functional teams including R&D;, formulation, packaging, and quality departments to address E&L; challenges and risks.
- Ensure compliance with regulatory guidelines (ICH, USP, FDA) and industry standards for E&L; testing.
- Maintain adherence to Good Laboratory Practices (GLP), Valuable Manufacturing Practices (GMP), and other relevant quality systems.
- Participate in risk assessments and provide scientific input on material safety evaluations.
- Stay updated on industry trends and advancements in IC/HPLC/LCMS/GCMS and E&L; testing.
- Manage laboratory workflows to meet project timelines and ensure high-quality data generation.
Qualifications: M.Pharm in Pharmaceutical Analysis or M.Sc. in Analytical Chemistry, Organic Chemistry, or a related field.
Experience:
- 2-8 years of hands-on experience on extractables and leachables in pharmaceutical or medical device industries.
- Proven experience in method development, validation, and routine analysis using IC/HPLC/LCMS/GCMS.