Expert Toxicologist for Impurity Safety Assessment and Risk Management job opportunity at Roche.

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DateMore Than 30 Days Ago bot
Roche Expert Toxicologist for Impurity Safety Assessment and Risk Management
Experience: 10-years
Pattern: full-time
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degreeAssociate
loacation Basel, Switzerland
loacation Basel....Switzerland

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. In Roche’s Pharmaceutical Research and Early Development organization (pRED) , we make transformative medicines for patients to tackle some of the world’s toughest unmet healthcare needs. At pRED, we are united by our mission to transform science into medicine. Together, we create a culture defined by curiosity, responsibility and humility, where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed. This position is located in TSAC, a department within the Pharmaceutical Sciences function.  We drive the non-clinical safety assessment of drug candidates from small molecules to complex biological products during the discovery and development phases at Roche.   The Opportunity We are offering an outstanding opportunity for a Senior Toxicologist to serve as the single point of contact for impurities assessments at Roche Basel. The position is placed in the Translational Safety Assessment chapter (TSAC) within Pharmaceutical Sciences at pRED Basel. This is a critical role within our team, requiring a strong scientific background and excellent communication skills to collaborate across various departments. You will play a key role in supporting the safety assessment of impurities and extractables/leachables throughout the value chain from late discovery to clinical development, as well as for established medicines, with compliance to the most current regulatory guidelines. Utilizing your expertise, you will collaborate with cross-functional teams to ensure the delivery of high-quality and compliant safety evaluations. Your main responsibilities will be:  You are the single point of contact for impurity and E&L risk assessments in drug substances and drug products You conduct comprehensive risk assessments of genotoxic impurities in line with ICH M7 and related guidance You perform toxicological evaluations of E&L profiles associated with container closure systems, devices, and manufacturing components You provide guidance on thresholds of toxicological concern (TTC), supporting product compatibility and safety dossiers You design and interpret in silico (Q)SAR analyses and, where appropriate, propose and evaluate in vitro/in vivo studies. You draft scientifically justified TBLs for impurities, leachables, residual solvents, and raw materials You apply appropriate risk assessment methodologies (e.g., AI, PDE, TTC) in accordance with ICH and EMA/FDA guidelines. You support the integration of TBLs into product specifications and cleaning validation procedures. You collaborate with cross-functional teams to ensure control strategies are scientifically sound and compliant.  You work closely with analytical chemists, formulation scientists, quality assurance, and regulatory affairs along with our Occupational Safety Teams. Your evaluations will be pivotal for the release of new batches from the manufacturing and quality functions You represent Roche as KOL in Industry Consortia and regulatory framework discussions groups You will advise and support project teams with regard to regulatory requests in the frame of impurities and contribute to internal scientific governance and decision-making forums on impurity and safety issues.  Who you are You hold a PhD and MSc in Toxicology or a pharmacology/toxicology-related discipline and have broad knowledge in toxicology and chemistry. You have a minimum of 5–10 years of experience in pharmaceutical or biotech toxicology, with strong expertise in impurity assessments and proven experience in E&L toxicological risk assessments. You possess working knowledge of genetic toxicology and have robust experience in the area of QSARs, computational toxicology, and the design and application of impurity safety databases. You have profound knowledge of ICH guidelines (M7, S9, Q3A/B/C/D, etc.), TTC principles, and relevant regulatory frameworks. You have a broad understanding of drug development and manufacturing processes, along with strong analytical skills and a commitment to scientific excellence. You possess strong communication and interpersonal skills, with experience engaging regulatory agencies (EMA, FDA, etc.). Unwavering focus, collaborative teamwork and exceptional delivery are key behaviours that drive our mission of doing now what patients need next. Together, we can be transformative. If you are passionate about contributing to a committed team and have the dedication to partnership and innovation, Roche is the place for you! Every role at Roche plays a part in making a difference in patients’ lives.  Apply now and join us in making an impact! Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.

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