Stellenbeschreibung:

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.

Purpose

As a member of the Site Leadership Team, the Head of Manufacturing PS4 is accountable for overseeing the entire process of turning raw material into drug substance (make-assess-release) of established commercial products. The role focuses on ensuring operational excellence, continuous improvement, and the resilience of the supply chain, while maintaining the highest levels of safety and quality compliance.

The “PS4” area of manufacturing is characterized by ambidexterity, which means a focus on robustness on one hand and flexibility on the other.

The “robust” area of manufacturing means minimal product costs, routine work, high degree of automation, few technical and production process changes, and low deviations.

The “Flexibility” area of manufacturing is characterized by high dynamics, focus on speed (more than cost), higher interdisciplinarity, high problem-solving skills, focus on right-first-time, and many technical changes.

Key Responsibilities

• Strategic Leadership & Manufacturing Execution: Provide strategic leadership and manufacturing execution, ensuring delivery, quality, and cost efficiency of drug substance production in Production Street 4. Build and maintain a robust, flexible supply chain, lead a multidisciplinary team, and drive technical transfers and product launches. Provide strategic advice to site leadership and shape the long-term vision for the DS Production PS4 line.
• Operational Excellence & Continuous Improvement: Drive process improvements, implement Lean practices, and optimize manufacturing processes for efficiency and robustness.
• Compliance & Quality Assurance: Ensure adherence to cGMP and quality standards, manage deviations, and maintain inspection readiness.
• Team Leadership & Development: Lead and develop a high-performing, multidisciplinary team, fostering innovation and growth.
• Technical Transfers & Product Launches: Support and execute the introduction of new molecular entities and product transfers, ensuring timely and compliant launches, managing regulatory inspections, and overseeing the production of newly acquired products like Afimkibart.
• Cross-Functional Collaboration & Network Integration: Partner with stakeholders and the global network to align operational goals.
• Safety, Cost, and Financial Performance: Ensure safety, manage budget (~20 million), and optimize cost per gram.
• Overall Accountability: Take full ownership of drug substance production, managing a team of approximately 100 FTEs and a budget of around 20 million, ensuring quality, delivery, and cost targets are met.

Qualifications

• Education: BS/BA in life sciences, physical sciences, engineering, or equivalent; Master’s or PhD with 10-15 years leadership experience; post-graduate or management training (e.g., MBA) is highly desirable.
• Experience: Experience in biotechnology, diagnostics, or pharmaceutical sectors; extensive biopharmaceutical manufacturing experience; deep knowledge of cGMP, quality systems, regulatory standards; expertise in Lean manufacturing and product development and launch.
• Skills: Strong leadership aligned with the VACC model, proficiency in Lean principles, team-building in regulated environments, change management, excellent communication, and proficiency in English and German (intermediate level encouraged).

Candidate documents

Please submit a current and meaningful CV. Additional documents like a cover letter are optional. Note that no further documents can be added after submission.

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Who we are

We are over 100,000 employees committed to advancing science and healthcare, impacting millions worldwide. Join us in building a healthier future.

Roche is an Equal Opportunity Employer.

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NOTE / HINWEIS:

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