Expert Toxicologist for Impurity Safety Assessment and Risk Management
Expert Toxicologist for Impurity Safety Assessment and Risk Management
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1 Vacancy
Job Description
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. Its 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. Thats what makes us Roche.
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 510 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 100000 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.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Employment Type
Full-Time
