The Sr. Analytical Chemist provides scientific knowledge and support regarding extractables and leachables (E& L) to the company. They have extensive scientific knowledge in E& L and analytical instrumentation techniques. They provide operations support through running equipment, performing identification of unknown compounds, performing data review, and drafting highly complex reports and protocols. They perform method development and validate analytical instrumentation. They participate on standard writing committees (AAMI/ISO) and bring the technical information from committee meetings, seminars, and technical training back to the company. They serve as a master trainer in the company and are a resource for cross section problem solving. They consult with clients on technical issues.

Education and experience requirements:

• M.S degree (Chemistry or biological science strongly preferred) and 5-10 years applicable mass spectrometry experience.
  • OR B.S. degree (Chemistry or biological science strongly preferred) and 10 years applicable mass spectrometry experience.
• Method development/validation experience and experience with other general laboratory equipment.

Scientific Expertise

• Trained on or close familiarity with at least 3 E& L analytical techniques (VOC, SVOC, NVOC, metals).
• Strong capability in identifying unknown compounds
• Development and validation of new analytical methods
• Troubleshoots problems with existing methods, procedures, instrument hardware and software. Identify the best course of action to remedy problems.
• Demonstrate full compliance to safety in the lab setting
• Participation on AAMI and ISO working groups
• Implement standard updates to internal protocols and procedures

Operations Support

• Drafting protocols and reports for highly complex studies
• Perform 1 st and 2 nd data review as needed
• Meet project timelines
• Complete Quality Events training and demonstrate proficiency in QE writing and process.
• Perform non-routine maintenance on instruments
• Provide technical project management support when needed

Technical Consulting Support

• Consult with clients on difficult technical matters
• Collaborate with toxicologists to ensure chemistry data is appropriate for a toxicological risk assessment.
• Host client visits and act as a technical resource for external audits

Regulatory Compliance

• Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.)
• Proactively suggests and owns implementation of necessary changes to stay in compliance with regulations
• Know and follow company policies and procedures
• Complete required training on time

Competencies of this position

• Research and development expertise
• Problem solving skills
• Team-oriented and cross-functional work aptitude
• Change advocate
• Strong project management abilities
• Verbal and written communication skills
• Customer service skills
• Math skills as applicable
• Ability to multi-task and be self-motivated
• Computer skills: proficiency with Microsoft Office products, CRM, and other relevant technologies
• Ability to work independently

Work Environment:

This job operates in a professional laboratory environment. This role routinely uses standard office equipment and lab equipment including but not limited to, computers, keyboards, computer mouse, telephones, photocopiers, file cabinets, microscopes, micropipettes, pipette aids, various hand tools and analytical equipment.

Possibility exists for exposure to biological and chemical hazards, exposure to carcinogenic compounds and other environmental aspects which may be considered unfavorable. Employees are expected to follow Biosafety and Chemical Hygiene policies, practices and procedures.

Travel

Occasional travel during the business day and out of the area or overnight travel is expected.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 8 of the top 10 global pharmaceutical companies.

Sotera Health goes to market through its three best-in-class businesses - Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Learn more about Sotera Health at soterahealth.com.