Extractables and Leachables Principal Scientist - Remote

Overview

The Extractables and Leachables Principal Scientist will perform a variety of analytical tasks related to extractables and leachables projects, ensuring the safety and compliance of drug products through advanced testing methodologies.

In Short

• Conduct analytical tasks for extractables and leachables projects.
• Develop and validate analytical methods for leachable testing.
• Interpret diverse analytical procedures.
• Utilize technical knowledge for method development.
• Perform investigations using mass spectrometry.
• Document work accurately and clearly.
• Maintain client communication and project responsibility.
• Part-time position with flexible hours.
• Located in Lancaster, PA, with remote options for experienced candidates.
• Comprehensive benefits including medical, dental, and vision.

Requirements

• Bachelor's in Chemistry or related field with 5 years of E/L experience.
• Knowledge of regulatory expectations for E/L studies.
• Experience with ISO 10993 and/or ISO 18562 testing.
• Participation in industry working groups (AAMI, USP, ISO).
• Experience with PFAS testing is preferred.
• Experience in a compliant lab (cGMP, GLP, ISO 17025).
• Proficient in operating LC/MS, GC/MS, and/or ICP systems.
• Experience in method development and validation.
• Authorization to work in the US without sponsorship.

Benefits

• Excellent full-time benefits including medical coverage.
• Dental and vision options available.
• Life and disability insurance provided.
• 401(k) with company match.
• Paid vacation and holidays.