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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.

Creating a world where we all have more time with the people we love. Thats 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 (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.

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 :

• 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 costeffectiveness. 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 longterm 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 highperforming multidisciplinary team fostering innovation and growth

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

• 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 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 1015years 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

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.