Du übernimmst die Verantwortung für die Arzneimittelproduktion, baust eine robuste Lieferkette auf und leitest ein leistungsstarkes Team.
Anforderungen
- •BS/BA degree in life sciences
- •Master and/or PhD with 10-15 years leadership experience
- •Post-graduate education or management training (MBA) highly desirable
- •Extensive experience in biopharmaceutical manufacturing
- •Deep understanding of cGMP and regulatory standards
- •Expertise in LEAN manufacturing and process optimization
- •Strong leadership in the VACC model
- •Demonstrated capability in Lean Manufacturing principles
- •Proven track record in building high-performing teams
- •Strong communication skills with regulatory authorities
- •Change management expertise with shared vision
Deine Aufgaben
- •Vollständige Verantwortung für die Arzneimittelproduktion übernehmen
- •Robuste Lieferkette aufbauen und pflegen
- •Strategische Beratung für die Standortleitung bieten
- •Vision formulieren und Schlüsselprojekte leiten
- •Kontinuierliche Verbesserung vorantreiben
- •Lean-Praktiken umsetzen und Herstellungsprozesse optimieren
- •Sicherstellen der Einhaltung von cGMP- und Qualitätsstandards
- •Abweichungen verwalten und Inspektionsbereitschaft aufrechterhalten
- •Hochleistungsfähiges, interdisziplinäres Team führen und entwickeln
- •Mit Stakeholdern und dem globalen Netzwerk zusammenarbeiten
- •Sicherheitsstandards einhalten und Budget verwalten
- •Kosten pro Gramm als Schlüsselmetriken optimieren
- •Verantwortung für einen Investitionsbetrag von 70 Millionen übernehmen
- •Vollständige Verantwortung für die Arzneimittelproduktion tragen
- •Ein großes Team und Budget von ca. 20 Millionen verwalten
Deine Vorteile
Zahlreiche Entwicklungsmöglichkeiten
Flexible Arbeitszeiten
Attraktive Vergütungspakete
Sonderprogramme für Familienhilfe
Original Beschreibung
# Head (m/f/d) Manufacturing Unit BioII/III
**Penzberg** | **Full time**
### 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 has a FTE responsibility of roughly 140 FTE in two different manufacturing buildings and a budget accountability of around 20 million.
**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
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.
**Roche is an Equal Opportunity Employer.**