Consulting Study Director

Sotera Health•Salt Lake City, UT

2d•Onsite

About The Position

The Consulting Study Director is a trusted advisor and consultative expert for clients and serves as the initial customer contact for validation studies, large projects, and other testing requiring a high degree of consultation. The position requires the highest level of customer service and broad technical expertise. The Consulting Study Director assists Sales with quote generation, develops test protocols, ensures testing setup is complete, and facilitates a smooth transition of projects to Production Study Directors. This enables production teams to focus on testing while delivering an exceptional client experience. The primary responsibility of this role is to help clients plan and organize projects through specialized expertise, high availability, and a high-touch customer service approach.

Requirements

Excellent internal and external customer service skills.
Strong technical knowledge and demonstrated technical ability.
Strong verbal and written communication skills.
Ability to work effectively with cross-functional teams.
Project management skills.
Facilitation of client and team meetings.
Ability to multitask and work independently.
Strong time management and responsiveness to communications.
Proficiency in Microsoft Office.
Regular and reliable attendance.
Bachelor's degree in Microbiology, Biological Sciences, Chemistry, or related field preferred
At least five years of NLI laboratory experience.

Responsibilities

Demonstrate deep understanding of industry regulations, standards, and guidelines (GMP, GLP, FDA, AAMI, ISO, ASTM, USP, etc.).
Collaboratively develop test protocols and testing strategies to meet client expectations.
Partner with Production Study Directors to ensure seamless project handoffs.
Assist 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.
Provide exceptional customer service.
Maintain extensive client phone contact.
Build strong relationships with clients, Sales, Service Center, and Production Study Directors.
Follow applicable regulatory requirements (GMP, GLP, ISO, etc.).
Stay current on regulatory trends.
Follow company policies and procedures.
Complete required training on time.
Stay current on scientific literature, test methods, and best practices.
Perform other duties as assigned.