Expert Toxicologist for Impurity Safety Assessment and Risk Management

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, prop...