Chemist

About the Company

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.

Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

Nelson Labs is seeking an experienced Chemist III to serve as a technical expert within our LC-MS data analysis team of the Analytical Chemistry team. This role is ideal for a highly knowledgeable LC-MS chemist who enjoys solving performing data analysis, developing, and validating new methods, mentoring laboratory professionals, and partnering directly with clients. As the single point of study control for assigned testing, you will oversee the technical conduct of the LC-MS portion of studies and ensure the accurate interpretation, analysis, documentation, and reporting of results.

You will also help advance our laboratory capabilities through method development, instrument validation, continuous improvement, and participation in industry standards committees.

• Serve as the technical expert for LC-MS chemistry testing and analytical techniques.
• Evaluate LC-MS data for scientific suitability and perform complex untargeted data analysis interpretation.
• Develop, write, review and validate SOPs, standard test procedures, protocols and analytical methods pertinent to your area of expertise.
• Perform method development and validation for new and existing testing methodologies.
• Ensure laboratory procedures and reports remain current with published methods and applicable standards.
• Maintain sample and data traceability throughout the testing process.
• Verify that test controls and monitoring activities are properly recorded and reviewed.
• Troubleshoot LC-MS instrumentation and determine the appropriate course of action to resolve technical issues.
• Perform non- routine instrument maintenance when needed.
• Optimize LC-MS instrument performance through new parameters, configurations and testing approaches as needed.
• Support laboratory failure investigations and root-cause analysis.

• Occasionally consult with clients regarding testing projects, technical requirements, test plans and testing parameters.
• Provide a high level of technical support to help clients understand testing standards and Nelson Labs’ capabilities.
• Work collaboratively to meet or exceed client expectations and agreed-upon turnaround times.
• Represent Nelson Labs at industry conferences as attendee.

• Follow applicable GMP, GLP, ISO 17025, ISO 9001, ISO 10993-18 and other regulatory requirements.
• Review laboratory data quality and recommend improvements to methods, procedures, quality and throughput.
• Monitor regulatory and industry developments and help the laboratory remain current with changing requirements.
• Ensure proper laboratory safety measures are followed.
• Maintain compliance with company policies, procedures and required training.

• Partner with laboratory leadership to manage testing workflow and meet sponsor expectations.
• Lead or support method validation, workflow improvement and laboratory capability projects.
• Collaborate across departments to ensure the successful completion and implementation of technical initiatives.
• Identify opportunities to improve laboratory capabilities, testing services, quality and operational efficiency.
• Help evaluate potential new testing methods and service offerings.

• Serve as a trainer for new…