Shire is the leading biotech company in rare diseases and sees a significant need for rare disease innovation. One example is Shire?s gene therapy hub in Orth an der Donau. In the past years the company has established a solid gene therapy platform based on adeno-associated viruses, which comprises vector optimization, analytical assays, scale-up expertise and a GMP-compliant production process. The experience gained in the process is also offered to external partners.
About the position
- Develop, implement and execute global gene therapy process development strategy
- Provide technical direction for and management of the Gene Therapy Team (incl. external development partners)
- Plan, overview, and execute all activities related to GT process development from lab scale to NON-GMP pilot scale according to plan (timeline, resources, quality)
- Implement and execute a make vs buy process in line with Shires strategy and the Biologics PD core competencies
- CAPEX, OPEX & Headcount Oversight (budget/forecast)
- Ensure internal and external Gene Therapy capabilities, skills, and capacities meet Shires requirements
- Guide staff in phase-appropriate process development, formulation development, process & product characterization, CMC-leadership and application of Quality by Design principles
- Deliver robust, reproducible, and scalable processes by application of scientifically sound approaches and methodology in close cooperation with the technical service and engineering teams
- Enhance process knowledge across all GT programs (internal and external) and ensure capture of product and process relevant knowledge
- Lead the development of the GT platforms and novel manufacturing technologies aligned with OpU strategies
- Ensure (pre-)clinical manufacturing oversight at internal and external manufacturing sites
- Provide technical input in various governance committees, functional and program decision making bodies
- Manage and oversee all aspects of organizational performance and development within the team incl. HR development, technical performance, and team initiatives
- Develop Gene therapy relevant IP and process know-how resulting in an competitive advantage for Shire
- Publish scientific papers in CMC relevant areas for gene therapy
- Present Shires GT topics at meetings and conferences
Skills you need:
- PhD in Chemical, Biological or Pharmaceutical Sciences
- 15 years in a leadership position
- Experience in the area of process development for gene therapy
- Proven ability to effectively lead a large team spread across different sites
- Preferred experience in managing global teams
- Ability to inspire others to contribute best even in difficult situations; to act as a leader in an encouraging way by balancing both support and demand.
- Ability to create a culture of cooperation where it is self-evident to talk openly about the necessity of change, to bring in new solutions and to stand for their implementation
As a leading global biotechnology company we have one mission every day: to lastingly improve the lives of people living with rare diseases. Crucial to our mission are our employees - our biggest asset - who enjoy a range of benefits and career opportunities, such as trainee and training programs, job rotations, apprenticeships, work-life balance (certified family friendly), company kindergarten, wellness center, cafeteria, etc. Here you can learn more about Shire in Austria.
We offer outstanding opportunities to motivated people regardless of your gender, age, skin color, ethnicity, sexual orientation or physical handicaps. Diversity is part of our success!
The minimum salary for this position is € 4.225,44 gross per month (full-time); increased payment is possible. We are looking forward to your application.