Extractable & Leachable - Specialist

E&L (Extractables & Leachables) Specialist

Department: FARD (E&L Lab)

Location: APLRC-II, Hyderabad

Key Responsibilities:

• 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), Good 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.