Job Description

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: Required: M.S degree (Chemistry or biological science strongly preferred) and 5+ years applicable mass spectrometry experience. OR B.S. degree (Chemistry or biological science strongly preferred) and 7+ years applicable mass spectrometry experience. ~ Method development/validation experience and experience with other general laboratory equipment. ~3 years of LCMS and Mass Spectrometry Scientific Expertise Trained on or close familiarity with at least 3 E&L analytical techniques (VOC, SVOC, NVOC, metals). Expertise in LC-MS untargeted analysis workflow This includes familiarity with and hands-on experience in sample prep through data analysis High resolution mass spectrometry experience highly desirable Strong capability in identifying unknown compounds through structural elucidation 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 1st and 2nd data review as needed Meet project timelines Complete Quality Events training and demonstrate proficiency in QE writing and process. Perform non-routine maintenance and troubleshooting on instruments such as LC-MS 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.) Work Environment: 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. About Us 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. About the Team Nelson Labs is a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Nelson Labs serves over 3,800 customers across 14 facilities in the United States, Mexico, Asia and Europe. We have a comprehensive array of over 800 laboratory tests supporting our customers from initial product development and sterilization validation, through regulatory approval and ongoing product testing for sterility, safety and quality assurance. We are regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues. Learn more about Nelson Labs at Safeguarding Global Health® - with every test we complete.

Job Tags

Full time, Worldwide, Night shift,

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