Drug Substance Manufacturing Operations Lead

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 in order to tackle some of the world’s toughest unmet healthcare needs. At pRED, we are united by our mission to transform science into medicines. 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 Preclinical Chemistry, Manufacturing, and Control (pCMC), a department within the Synthetic molecule research organization in pRED Therapeutic Modalities, where we pave, in a diverse, ambitious and innovative environment, the path to bring drug candidates from early research into development. We are CMC experts and build our strength on a broad diversity of technical expertise in chemistry, formulation design, material science and analytical chemistry, delivering and innovating in the space of small molecules, peptides and nucleic acid based medicines.

The Opportunity

We are offering an outstanding opportunity for a CMC professional to become part of our chemistry team. In this dynamic role, you will play a pivotal part in paving the path for our drug candidates, overseeing the entire drug substance manufacturing from early toxicological studies to, and including, phase I clinical supply.

Drug Substance Manufacturing Operations Lead:

• You'll lead the charge in coordinating all drug substance manufacturing, guiding our groundbreaking drug candidates from early research into development.
• You will champion a culture of compliance, ensuring unwavering adherence to cGMP and all quality and regulatory standards.
• You are responsible for driving manufacturing efficiency, overseeing facility management, and developing future capabilities through strategic projects and continuous improvement.
• You will collaborate closely with a diverse range of teams, including Quality Assurance and R&D, to optimize processes and propel projects toward success.
• As a People Leader, you will lead, coach, and serve as a development partner for a team of 8-12 people, fostering an environment where everyone can thrive.
• You will also be a key partner in our success, managing vital vendor relationships and coordinating external manufacturing activities.

Who You Are

• A bachelor’s degree in chemistry or engineering is a must, while a master’s or Ph.D. is highly preferred.
• You bring proven leadership experience from a pharmaceutical or biopharmaceutical manufacturing environment, with deep expertise in drug substance, specifically in oligonucleotides or small molecules.
• Your knowledge of cGMP and other regulatory requirements is second to none, and you excel at problem-solving and leading people.
• You have exceptional communication skills, with a track record of building relationships and collaborating across diverse teams to influence key stakeholders.
• You are a strategic thinker with a passion for continuous improvement and a commitment to operational excellence.

Ready to take the next step? We'd love to hear from you. Apply now to explore this exciting opportunity!

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.