Product Safety and Compliance; PS&C - Senior Specialist

Position: Product Safety and Compliance (PS&C) - Senior Specialist 1
Shape the Future with Us. At Lubrizol, we're transforming the [industry/market – link to relevant LZ business page, if applicable] through science, sustainability, and a culture of inclusion. As part of our global team, you'll be empowered to make a real impact—on your career, your community, and the world around you.

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, Cons Expo, 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,…