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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 (m/f/d) of Manufacturing Unit BioII/III 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.
This area of manufacturing is characterized by: mono products, low number of deviations, optimized product costs, routine work, high degree of automation and little production process changes.
Key Responsibilities
Strategic Leadership & Manufacturing Execution :
* As Head of Manufacturing, you will have full accountability for the entire drug substance production process in the EPO & CERA space, ensuring delivery, quality, and cost-effectiveness. You will build and maintain a robust supply chain, collaborating with other departments to ensure material availability. Additionally, you will provide strategic consulting to the site head, formulate vision, and lead key projects to develop long-term business strategies.
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
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
* Responsibility for a 70 million capex invest in order to refurbish the aged facility to higher standards
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 140 FTE in two different manufacturing buildings 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 10-15years 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
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.
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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 at Penzberg, near Munich, employs more than 7,000 people. The site is one of the largest biotechnology centers in Europe and the only Roche site with research, development and production for both Pharmaceuticals and Diagnostics under one roof. From your beginning with Roche, our motivated team will welcome and support you. Numerous opportunities for personal development, flexible work hours, attractive compensation packages and special family assistance programs are available.
Roche is an Equal Opportunity Employer.