Chemist

About the Company

Sotera Health, inspired by Soteria, the Greek goddess of safety, reflects the company’s unwavering commitment to its mission, Safeguarding Global Health®. As a leading global provider of mission-critical sterilization, lab testing, and advisory services for the healthcare industry, Sotera Health has nearly 200 years of combined tenure across its businesses. With industry-recognized scientific and technological expertise, the company ensures the safety of millions of patients and healthcare practitioners annually. Across 64 facilities worldwide, over 3,000 employees are dedicated to safety and quality, serving more than 5,800 customers in over 50 countries, including over 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

About the Role

Nelson Labs is seeking an experienced Chemist III to serve as a technical expert within the LC-MS data analysis team of the Analytical Chemistry team. This role is ideal for a highly knowledgeable LC-MS chemist who enjoys 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, ensuring accurate interpretation, analysis, documentation, and reporting of results. You will also help advance laboratory capabilities through method development, instrument validation, continuous improvement, and participation in industry standards committees.

Responsibilities

• Technical and Scientific Leadership
  • 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.
• Client Partnership
  • 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 an attendee.
• Quality and Regulatory Compliance
  • 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.
• Project Management and Continuous Improvement
  • 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.
• Training and Industry Leadership
  • Serve as a trainer for new and existing employees.
  • Review scientific literature and participate in continuing education to remain current on technical and scientific developments.
  • Participate in applicable industry standards committees.
  • Share knowledge of emerging chemistry methods, technologies, and industry opportunities with laboratory leadership and team members.

Requirements

• Ph.D. in Chemistry preferred; or Bachelor’s or master’s degree in Chemistry or a closely related scientific discipline.
• Minimum five years of applicable laboratory experience.
• Strong knowledge of LC-MS chemistry, methods, and data analysis activities.
• LC-MS analytical instrumentation experience strongly preferred (experience with Thermo Scientific Orbitrap and/or Exploris is a plus).
• Experience with analytical method development and/or site-to-site transfer, validation, troubleshooting, and technical documentation.
• Working knowledge of GMP, GLP, ISO 17025, ISO 9001, or similar regulated laboratory requirements.
• Experience performing extractable and leachable testing and/or related non-targeted data analysis; medical device testing per ISO 10993-18 preferred.
• Strong written and verbal communication skills.
• Demonstrated attention to detail and commitment to data quality.
• Strong problem-solving, project management, and client-service skills.
• Ability to work cross-functionally, manage multiple priorities, and operate with a high degree of independence.
• Leadership, training, and change-management capabilities.

Work Environment and Physical Requirements

• Operates in a professional laboratory environment and routinely uses computers, standard office equipment, microscopes, micropipettes, pipette aids, hand tools, and analytical laboratory equipment.
• The laboratory environment may include exposure to biological and chemical hazards, carcinogenic compounds, and other potentially unfavorable conditions. Employees must follow all biosafety, chemical hygiene, and personal protective equipment requirements.
• Stand and move between laboratory and office locations for approximately 30% of the workday and work at a computer for approximately 70% of the workday.
• Bend, stoop, crouch, crawl, climb, push, and pull as required.
• Wear safety glasses, goggles, face shields, gloves, laboratory coats, and other required personal protective equipment.
• Lift up to 45 pounds.
• Travel occasionally, including potential overnight or out-of-area travel.

Core Values

At Nelson Labs, work is guided by four core values:

• Integrity
• Quality
• People
• Fun