Consulting Study Director – Extractables & Leachables

Job Summary

The Consulting Study Director – Extractables & Leachables is a trusted advisor and consultative expert for clients. This role serves as the initial customer contact for extractable and leachable studies and projects, assisting Sales with quote generation, sponsor communication, developing test protocols, and facilitating testing in the lab.

Essential Job Functions

• Demonstrate deep understanding of industry regulations, standards, and guidelines (GMP, GLP, FDA, AAMI, ISO, ASTM, USP, etc.).
• Specifically chemical characterization testing per ISO10993-18. Significant experience required with medical device or pharma extractable and leachable testing (medical device E&L is preferred).
• Collaboratively develop extractable and leachable test protocols and testing strategies to meet client expectations and regulatory needs.
• Aid clients and production teams with unexpected or unique testing challenges.
• Coordinate technical consulting activities including summary protocols, written justifications, sample plan justifications, risk assessments, and special projects.

Customer Focus

• Provide exceptional customer service.
• Maintain extensive client phone and email contact.
• Build strong relationships with clients, Sales, Service Center, and the Lab team.

Regulatory Compliance

• Follow applicable regulatory requirements (GMP, GLP, ISO, etc.) including ISO10993-18.
• Respond to FDA feedback of Nelson Labs testing strategies and studies.
• Stay current on regulatory trends.
• Follow internal company policies and procedures.

Professional Development

• Complete required training on time.
• Stay current on scientific literature, test methods, and best practices.
• Perform other duties as assigned.

Job Requirements

• Excellent internal and external customer service skills.
• Strong technical knowledge and demonstrated technical ability.
• Strong verbal and written communication skills.
• Able to work effectively with cross-functional teams.
• Project management skills.
• Facilitation of client and team meetings.
• Able to multitask and work independently.
• Strong time management and responsiveness to communications.
• Proficiency in Microsoft Office.

Education & Experience

• Bachelor's degree in Chemistry or related field preferred.
• At least 5 years Extractables and Leachables lab experience.