Product Safety and Compliance (PS&C) - Senior Specialist 1

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Product Safety and Compliance (PS&C) - Senior Toxicologist

Knowledge and Skills:

• Thorough understanding of regulatory activities, hazard and risk data for purchased raw materials and manufactured products introduced to the market, along with proficiency in internal/external systems and databases, to be an effective contributor. Have expert knowledge and experience in one or more areas of specialization. Capable of integrating information from various sources to develop optimal solutions. Able to communicate complex technical and regulatory issues to diverse audiences across Lubrizol.

Ecotoxicology

• Understand inherent biodegradation tests to assess the potential for biodegradation under less stringent conditions, proficiency in interpreting test results to determine the inherent biodegradability of substances
• Select the adequate dosing regimen (WAF, saturation solution, etc.) in ecotoxicity study for superhydrophobic substances, UVCB, or mono-constituent substances
• Evaluate acute or chronic toxic effects of substances on aquatic organisms (algae, fish, daphnia), and understand various techniques that are used in analytical studies (HPLC, GC, TOC, ICP, etc.)
• Take responsibility for 5-batch studies to demonstrate that the manufacturing process reliably produces batches of substance with consistent quality attributes
• Take responsibility for biobased content assay (ASTM 6866) to determine the fraction of a product that comes from renewable biological sources

Human Health (Good to have, but not mandatory)

• Understand the primary mechanisms through which genotoxic agents can cause genetic damage. Follow a structured approach that begins with in vitro tests and progresses to in vivo tests as needed, comprehensively assess the genotoxic potential of substances
• Perform extractable and leachable studies to identify potentially harmful chemicals
• Assess the safety and performance of medical devices when implanted in living organisms, familiar with ISO 10993 series standards for biological evaluation of medical devices

Risk Assessment

• Master risk assessment using higher-tier tools (EUSES, ART, ConsExpo, Simple treat, etc.)
• Develop and utilize sPERCs to improve the accuracy and relevance of environmental risk assessments for chemicals used in specific industries
• Evaluate the potential risks that PBT, PMT or physically hazardous materials pose to human health and the environment, prepare comprehensive reports detailing the methods, results, and interpretations of the risk assessment. Communicate findings to customers and regulators
• Apply appropriate Safety Concern Threshold (SCT) or Toxicological Threshold of Concern TCs) to assessment of mutagenic carcinogens, sensitizers, etc.
• Understand the regulatory basis relevant to Toxicological Risk Assessment (TRA) for medical devices (e.g., material changes assessment, E&L data, toxicity profile based on literature data, QSAR, nature and magnitude of patient contact, patient population, calculate tolerable exposure level based on routes of administration, derive margin of safety)
• Provide a scientifically sound approach to managing the risk of CMR impurities in pharmaceuticals

Accountability/ Scope of Role:

• Your responsibilities include conducting ecotoxicology assessments and interpreting international requirements. This role requires a strong understanding of ecotoxicology principles and the ability to apply chemistry knowledge to evolving global chemical control laws and product safety assessments.
• Monitor physical chemical, human health and/or environmental toxicology testing. Responsibilities regarding third-party research laboratories include evaluating contract research laboratories for expertise in specific testing required, adherence to GLP, quality of work product, comparative costing, and adequacy of turnaround time. Coordinate all aspects of testing studies, including assessment of new data to meet regulatory reporting obligations, assisting in report review and writing
• Perform safety assessments for chemical used in products developed and marketed by Lubrizol in support of new chemical notifications, to meet global hazard communication requirements, and to further product stewardship initiatives
• Monitor regulatory and toxicology communications, databases, and state of the science for issues of relevance to PSCD and the business; analyze issue for impact on business; communicate issues either to supervisor or businesses
• Plan and complete tasks for more broadly defined projects and own work assignments within agreed timelines, with appropriate initial support or supervision where required
• Assist on more complex projects, e.g. problems involving causes which are not obvious but where precedents may exist. Progress and results are periodically reviewed. Target active participation in inter-disciplinary projects as a contributor or key contributor  
• Develop and articulate credible technical positions. Effectively present technical and toxicology information to both internal and external audiences.
• Coordinate and manage ecotoxicology, environmental, and phys‑chem testing programs with third‑party laboratories, ensuring high‑quality data and timely completion.
• Perform chemical safety assessments by integrating ecotoxicology and phys‑chem data to support global new chemical notifications, hazard communication requirements, and product stewardship needs.
• Prepare and present technical and regulatory information; organize and interpret study results; support the preparation of regulatory dossiers for global submissions.
• Contribute to product defense strategies by applying expertise in ecotoxicology, environmental fate, and related scientific disciplines.
• Demonstrate working knowledge of internal data management systems (e.g., SAP, SharePoint) for data traceability, documentation, and compliance.
• Monitor global regulatory and scientific developments in ecotoxicology and environmental safety; communicate emerging issues to supervisors and technology teams.
• Provide expert consultation, including report writing, literature reviews, data‑gap analysis, customer responses, and participation in relevant trade association groups or panels.

Influence/ Leadership:

• Proactively participate in setting individual and team objectives and timelines
• Consult all departmental colleagues and stakeholders affected by plans or decisions
• Self-motivated, demonstrate a “can do” spirit, a sense of ownership and commitment 
• Advocate new ideas and improvements, address difficult issues

Education and Professional Experience:

• PhD, MS, or BS in Biology, Toxicology, or a related scientific discipline
• Typically > 5 years of experience in PS&C, Toxicology, or other relevant industrial background.

Lubrizol: Imagined for Life. Enabled by Science. ™ Delivered by You. For nearly 100 years, The Lubrizol Corporation, a Berkshire Hathaway company, has been at the forefront of innovation to enhance everyday life, advance mobility, and make the modern world work better. Our specialty chemistry solutions—from engine oils, performance coatings, and skincare to medical devices and plumbing systems —are powered by the expertise, passion, and commitment of people like you. We tackle the world’s toughest challenges with science-based solutions, deeply understanding our customers to deliver innovative chemistry and differentiated value. Our inclusive culture, dedication to safety, and incredible global talent drive our success. Our solutions meet the evolving needs of the modern world—brought to life by science and, most importantly, delivered by you. Whether you're in the lab, on the production floor, or in the office, you'll be part of a team around the world that empowers you to think boldly, drive results, and contribute to solutions that shape a better, more sustainable future.  We win because of you. Let’s build the future together.