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:
The Head of Late Stage Development manages the a team of ca. 70 highly skilled employees divided into several teams. In this role you will be:
- Accountable/Responsible for GT process development (upstream and downstream in pilot) and the optimization of Shire’s gene therapy platform
- Accountable for Preclinical Production and material supply
- Accountable for Process Implementation and process transfer to manufacturing
- Accountable for Manufacturing support (e.g. input in Process Risk Assessments, Assessment of production non-conformancies, process change controls)
- Accountable for GMP & non-GMP Media&Buffer and Equipment preparation
- Actively participate in Due Diligence and Technical Assessments
- Plan the mid-term and long-term activities to ensure achievement of milestones
- Identify, prioritize and provision resources to meet the annual goals
- Organizes Team meetings
- Build and lead a high performing team consisting of managers, scientists and research associates
- Ensure continuous skills development (e.g. cross-functional training), motivation and coaching of the team members
- Maintain open communication and collaboration with internal partners from GT Later Stage Development, Product Stewardship, Formulation Development, Process Analytics GT
- Represent Process Development to external collaboration partners and customers
Skills you need:
- Postgraduate degree in the biological or chemical field, ideally an education with a specialization in biotechnology or biochemistry
- Profound experience in process industrialization of gene therapy process (e.g.cell biology, fermentation, protein purification) and biotechnology.
- Demonstrated leadership skills and experienced in resolving conflict situations
- Several years of experience within the biotechnological- or pharmaceutical industry.
- Ability to develop and manage high performing teams
- High level of customer orientation and organizational skills
- Ability to identify and resolve complex technical issues
- Enthusiasm, decisive and motivating personality
- Excellent verbal and written communication skills in English and German
- Experienced in setting up, designing and monitoring implementation of research projects
- Experienced in establishing new methods in the lab and planning of experiments
- Solid GLP and GDP knowledge
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!