Toxicological Risk Expert
hace 1 día
El Masnou
Your Role ¿Tiene las siguientes habilidades, experiencia e impulso para tener éxito en este puesto? Descúbralo a continuación. The primary purpose of the role is to protect operator health and ensure environmental compliance across all sites by conducting comprehensive toxicological risk and safety assessments (ExpoCat reports) for Active Pharmaceutical Ingredients (APIs), intermediates, and other chemicals. Acting as the scientific pillar for industrial hygiene and equipment containment strategies, the job holder provides critical support to cross‑functional departments, including SHE, Quality, Business Development, Project Management, and Engineering. Key responsibilities include identifying product‑related risks, calculating Occupational Exposure Limits (OELs), defining ExpoCat classifications, and preparing timely reports (ExpoCat reports) to facilitate safe operations and decision‑making on new products, while ensuring audit/inspection readiness through robust, traceable toxicological justification and documentation. Your Profile At Siegfried we are currently looking for a Toxicological Risk Expert to join our Corporate SHE & S team in our site based in Barberà del Vallès. Your main responsibilities will be Below is a summary of the main responsibilities: Toxicology and Risk Assessment • Research and evaluate data available to identify potential risks of substances (preclinical and clinical data, toxicological data, etc)., • Independently conduct comprehensive, science‑based toxicological risk assessments for new and existing Active Pharmaceutical Ingredients (APIs), drug products, intermediates and other chemicals across all global manufacturing sites., • Prepare structured safety assessments specifically addressing potentially genotoxic risks of substances., • Ensure all evaluations strictly adhere to current scientific standards and toxicological guidelines. Occupational Exposure Limits & Hazard Classification • Calculate, establish and document internal Occupational Exposure Limits (OELs) and Permitted Daily Exposures (PDEs) using current scientific standards and a risk‑based approach., • Define and assign ExpoCat classifications (Occupational Exposure Banding) for all handled substances, ensuring accurate hazard communication., • Perform regular toxicological reviews of existing OELs and ExpoCat classifications, ensuring timely revisions whenever new toxicological data becomes available., • Maintain and manage master databases containing updated risk and toxicological data for all APIs and handled substances. Global SHE Support & Cross‑Functional Advisory • Active member of the API committee, providing toxicological input and recommendations to support safe product introduction and lifecycle decisions., • Partner with Business Development and Project Management to evaluate the toxicological feasibility of new products, delivering timely reports for go/no‑go decision‑making., • Provide global support for occupational safety management at all sites through comprehensive risk analysis and hazard assessments (ExpoCat reports)., • Respond to product‑specific inquiries from internal customers, discussing data requirements and providing expert advice to stakeholders., • Assist in finding creative, practical solutions to workplace safety challenges., • Review and evaluate changes in SHE's toxicological risk management, providing necessary supporting data and rationales for those changes. Technical documentation, Compliance & Audit Readiness • Act as subject‑matter expert for OEL/PDE and ExpoCat topics; provide scientific recommendations and support decision‑making in accordance with SHE governance/committee processes., • Evaluate, author and maintain high‑quality provisional and final ExpoCat reports in a timely manner to support informed decision making., • Ensure all toxicological documentation is up‑to‑date and audit‑ready for internal reviews and external health authority inspections., • Guarantee strict adherence to local regulations and international frameworks (e.g. OSHA, EMA/ICH, ACGIH/NIOSH). Training, Leadership & Continuous Improvement • Participate in the development of materials and provide specific training to stakeholders on ExpoCat reports and how to properly interpret them., • Keep supervisors informed about the progress of assigned projects and proactively recommend strategies or solutions to product‑related toxicological issues., • Support initiatives and topics related to toxicological risk assessment aimed at global process improvement., • Actively share knowledge with other team members to foster a collaborative expert environment, performing other duties as required to support the department's mission., • Stay updated on industry's best practices and new toxicological data. Integrate them to the current process., • Inform supervisor of any situation that may pose a risk to your own Health and Safety or that for others, as well as to the environment. Ideal Background Education • University degree in medicine, pharmacy, biology, biochemistry or a closely related scientific discipline with MSc/PhD in toxicology or closely related discipline with demonstrated OEL/PDE experience., • Board certification as a Registered Toxicologist (e.g. ERT- European Registered Toxicologist or similar) is highly preferred and considered a strong asset., • Coursework or certifications in Industrial Hygiene, Occupational Health or Environmental Toxicology is a plus., • Practical knowledge or formal training in "in silico" toxicological assessments and computational toxicology (e.g. QSAR modelling, read‑across methodologies, structural alerts) is highly desirable for predicting toxicity when empirical data is limited. Languages • Fluent English (the role requires drafting complex scientific reports and communicating with global stakeholders) level C1‑C2; other European language a plus. Travel • Expected 10 – 20 % travel. Experience • Minimum of 3+ years of hands‑on experience in toxicological risk assessment, preferably within the pharmaceutical, chemical or regulatory consulting industries., • Proven practical experience in calculating and documenting Occupational Exposure Limits (OELs) and Permitted Daily Exposures (PDEs)., • Strong familiarity with occupational exposure banding and acute hazard communication protocols., • Deep understanding of international regulatory frameworks and guidelines related to pharmaceutical manufacturing, health‑based exposure limits and worker safety (e.g. EMA guidelines, ICH M7L, ICH Q3, ISPE Risk‑MaPP, REACH, OSHA)., • Demonstrated experience working effectively with cross‑functional teams, particularly SHE, Industrial Hygiene, Quality assurance, Engineering and Business Development., • Experience leading / supporting internal SHE audits and external inspections, and follow‑up/closure of CAPAs related to occupational exposure limits and hazard banding. Key Skills & Competencies • Pragmatic & Solution‑Oriented Assessment (Business Partner Mindset): Ability to translate complex toxicological data into practical. Capable of avoiding overly restrictive theoretical boundaries by finding safe, efficient solutions that balance maximum scientific rigor and worker safety with operational feasibility and manufacturing realities., • Advanced analytical & Conceptual thinking: Strong capability to critically evaluate, interpret and synthesize complex scientific literature, pre‑clinical/clinical data and computational models (e.g. QSAR, read‑across) to form sound, evidence‑based conclusions under uncertainty., • Decisiveness Under Uncertainty: Proven ability to make confident science‑based safety decisions and recommendations even when dealing with incomplete data sets or novel chemicals entities during early development phases., • Effective Interface Communication: Excellent team and communication skills, ensuring efficient, sustainable and cross‑functional interface communication. Capable of explaining complex toxicological concepts clearly to non‑experts and internal stakeholders., • Structured & Goal Oriented Work Style: Very good organizational skills with a highly structured approach to work, ensuring timely delivery of risk assessments., • Regulatory Knowledge & Auditing Skills: Deep, up‑to‑date knowledge of global occupational health and pharmaceutical regulations, coupled with the composure and expertise required to defend internal OELs/ PDEs directly to health authorities as needed. xcskxlj, • Process improvement & Mentoring: A proactive approach to optimizing internal SHE workflows, managing databases efficiently and a willingness to train and mentor colleagues on the interpretation of ExpoCat reports. Your Benefits • Annual Bonus, • Two days of home office per week, • Free parking, • Good public transport available to reach the site, • Subsidized canteen on‑site or restaurant ticket: to use when eating out or working from home, • Medical, life, and accident insurance, • Access to "Club Siegfried": an exclusive platform with discounts and offers on over 400 services #J-18808-Ljbffr
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