Roche Diagnostics GmbH
Germany, Penzberg
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 the one handside robustness and on the other hand flexibility.
The “robust” area of manufacturing means minimal product costs, routine work, high degree of automation, few technical and production process changes and low number of deviations.
The “Flexibility” area of manufacturing is characterized by: generally high dynamics, focus on speed, speed more important than cost, higher degree of interdisciplinarity, high problem solving competency, focus on right-first-time and many technical changes.
Key Responsibilities
Strategic Leadership & Manufacturing Execution:
* As Head of Manufacturing, you will provide strategic leadership and manufacturing execution, taking full accountability for the drug substance production process in Production Street 4, ensuring delivery, quality, and cost efficiency. You will build and maintain a robust, flexible supply chain, lead a multi-disciplinary team, and drive successful technical transfers and product launches. Additionally, you will provide strategic advice to site leadership, shaping the vision and long-term strategies for the DS Production PS4 line.
Operational Excellence & Continuous Improvement:
* Drive continuous improvement, 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, multi-disciplinary team, fostering innovation and growth
Technical Transfers & Product Launches:
* The role involves supporting and executing the introduction of new molecular entities and the successful technical transfer of products. This includes ensuring timely and compliant market launches and regulatory compliance through all stages of development and licensure. Collaboration with internal and external stakeholders is crucial for successful product launches, along with managing regulatory inspections and Health Authority engagements. The position also holds responsibility for the production of newly acquired products, such as Afimkibart.
Cross-Functional Collaboration & Network Integration:
* Partner with stakeholders and the global network to align on operational goals and initiatives
* Safety, Cost, and Financial Performance: Ensure safety, manage budget, and optimize cost per gram as a key productivity metric
Overall Accountability:
* Take full ownership of drug substance production, including quality, delivery, and cost, managing a large team and budget
* The role is has a FTE responsibility of roughly 100 FTE and a budget accountability of around 20 millions
Qualifications
Education:
* BS/BA degree in life sciences, physical sciences, engineering, or an equivalent combination of education and experience
* Master and/ or PhD with 10-15 years leadership experience
* Post-graduate education or management training (e.g., MBA) is highly desirable
Experience:
* Extensive experience in biopharmaceutical manufacturing, including cross-functional leadership and proven success in end-to-end pharmaceutical business execution
* Deep understanding of cGMP, quality systems, and regulatory standards
* Expertise in LEAN manufacturing and process optimization under stringent regulatory conditions.
* Expertise in technical development and launch of new products (Incl. strong understanding of regulatory aspects of new product launches)
Skills:
* Strong leadership in the Visionary, Architect, Coach, Catalyst (VACC) model, with the ability to remove barriers and foster collaboration across Manufacturing Units
* Demonstrated capability to apply Lean Manufacturing principles, enhance operational efficiency, and drive continuous improvement
* Proven track record of building high-performing, cross-functional teams in complex, regulated environments
* Strong communication skills, including experience presenting to regulatory authorities and managing inspections
* Change management expertise with the ability to create a bold shared vision and lead teams through periods of uncertainty
Candidate documents
Please send us a current and meaningful CV. Other documents, e.g. a cover letter, are welcome to be added optionally. Please note before sending your application that no further documents can be added afterwards.
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.
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