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The Position

About the Position

Join our Material Science and Strategy team within Pharma Cell & Gene Therapy (PTC) and play a decisive role in shaping the future of Cell and Gene Therapy (CGT). Our team of dedicated scientists and engineers operates in a highly dynamic and cross-functional environment to ensure a reliable supply of high-quality, well-controlled materials for our innovative therapies. As a Material Qualification Coordinator, you will take on a key strategic role, planning and steering the qualification and management of critical materials across the entire product lifecycle.

Your Impact

Leading cross-functional teams from Development, Manufacturing, Quality, Regulatory, and Procurement to successfully execute the material strategy for our CGT portfolio.

You will develop and implement the strategy for material qualification and onboarding for our cell and gene therapy programs, ensuring seamless alignment across all functions.

Planning and coordinating key activities such as material risk assessments, the development of specifications, and the management of material changes (Change Management).

You will establish lean methodologies, dashboards, and standardized processes to efficiently steer GMP material qualification and ensure compliant documentation within our Quality Management System.

Supporting the introduction of new raw materials and single-use technologies in close collaboration with our manufacturing sites, while also driving the evolution of a holistic material platform strategy.

Creating and reviewing qualification documents (e.g., USR, risk assessments, technical reports) and providing expert support during audit preparations.

Your Profile

You hold a Bachelor's degree in Life Sciences, Biotechnology or Engineering; a Master's degree or PhD is preferred.

You bring extensive professional experience in the biopharmaceutical industry and a cGMP environment (8-11 years with a Bachelor's, 6-9 years with a Master's, or 3-6 years with a PhD).

You have expert knowledge of cGMP regulations and quality assurance principles, ideally within the field of Cell and Gene Therapy (ATMPs).

You possess a deep understanding of materials, their associated risks, and the regulatory implications within CGT.

Your approach to work is defined by strategic thinking, strong problem-solving skills, and a commitment to continuous improvement.

You are proficient with IT systems (e.g., SAP, LIMS, EDMS) and are an experienced facilitator in cross-functional matrix teams.

You are a compelling communicator with excellent command of written and spoken English and are willing to travel internationally as needed (up to 20%).
 

What we offer

A role with a true sense of purpose, where you will directly contribute to the development of highly innovative medicines for patients.

An international and diverse team that fosters a culture of collaboration, trust, and continuous personal and professional growth.

Targeted, individual development opportunities designed to help you realize your full potential.

The psoition is limited to 2 years.

Your Application

We make it easy for you! Please simply upload your current CV and the certificate of your highest qualification.

 

We look forward to receiving your application!

Your contact to us! With people. For people.

Do you need further support?

Please have a look at our FAQs, you will find them via https://careers.roche.com/global/en/faq.

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.