You are responsible for managing the entire drug substance production, ensuring quality and cost efficiency while driving improvement initiatives and leading a diverse team. Your role includes strategic collaboration and accountability for significant budgets and investments.
Anforderungen
- •BS/BA degree in life sciences
- •Master and/or PhD with 10-15 years leadership experience
- •Post-graduate education (e.g., MBA) highly desirable
- •Experience in biotechnology in diagnostics
- •Extensive experience in biopharmaceutical manufacturing
- •Deep understanding of cGMP and regulatory standards
- •Expertise in LEAN manufacturing and process optimization
- •Strong leadership in VACC model
- •Demonstrated capability in Lean Manufacturing principles
- •Proven track record of building cross-functional teams
- •Change management expertise with shared vision
- •Strong communication skills for regulatory engagements
- •Proficiency in English and German required
Deine Aufgaben
- •Oversee the entire drug substance production process.
- •Ensure delivery, quality, and cost-effectiveness.
- •Develop and maintain a robust supply chain.
- •Collaborate with departments for material availability.
- •Provide strategic consulting to the site head.
- •Formulate long-term business strategies.
- •Drive continuous improvement and implement Lean practices.
- •Optimize manufacturing processes for efficiency.
- •Ensure adherence to cGMP and quality standards.
- •Manage deviations and maintain inspection readiness.
- •Lead a high-performing multi-disciplinary team.
- •Foster innovation and team growth.
- •Partner with stakeholders on operational goals.
- •Align initiatives with the global network.
- •Manage safety, budget, and cost optimization.
- •Oversee a 70 million capex investment for facility refurbishment.
- •Take full ownership of drug substance production.
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 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:
* Experience in biotechnology within the diagnostics or pharmaceutical sectors is essential
* 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
* Change management expertise with the ability to create a bold shared vision and lead teams through periods of uncertainty
* Strong communication skills, including experience presenting to regulatory authorities and managing inspections
* We require proficiency in both English and German. Candidates with an intermediate level of German are encouraged to apply, as we value commitment to language improvement. Roche supports continuous learning and offers resources to assist employees in enhancing their language skills.
**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.**