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The Position

A healthier future. Its 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.

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 (makeassessrelease) 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 ofautomation few technical and production process changes and low number of deviations.

The Flexibility area of manufacturing is characterized by: generally highdynamics focus on speed speed more important than cost higher degree of interdisciplinarity highproblem solving competency focus on rightfirsttime and many technical changes.

Key Responsibilities

Strategic Leadership & Manufacturing :

• As Head of Manufacturing you will provide strategic leadership and manufacturing 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 multidisciplinary team and drive successful technical transfers and product launches. Additionally you will provide strategic advice to site leadership shaping the vision and longterm 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 highperforming multidisciplinary 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.

CrossFunctional 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 1015 years leadership experience

• Postgraduate education or management training (e.g. MBA) is highly desirable

Experience:

• Extensive experience in biopharmaceutical manufacturing including crossfunctional leadership and proven success in endtoend pharmaceutical business

• 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 highperforming crossfunctional 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

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A healthier future drives us to innovate. Together more than 100000 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 lifechanging healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche at Penzberg near Munich employs more than 7000 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.