Shire Head of Global CMC Support for Complex Proteins (m/f) in Orth an der Donau (Baxalta), Austria
Shire’s R&D pipeline is with 30+ programs one of the most promising and complex pipelines in the entire biopharmaceutical industry. Research and Development programs in 6 therapy areas encompass pharmaceutical and biopharmaceutical substances with highly diverse forms of administration. PDTS (Process Development and Technical Services) in Austria operates in a global environment collaborating with over 30 locations worldwide to develop processes and analytical methods for new substances as well as to support large-scale production for approved medication. PDTS strives to find innovative ways of successfully implementing product-related ideas for the benefit of our patients.
A new and challenging opportunity has become available at the Shire Austria plant for a Head of Global CMC Support. This person could also sit at the Shire Plant in Neuchâtel Switzerland.
This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change-agile professional to embrace a team-based culture and more specifically within the Global CMC PDTS teams in a world-class Biotech manufacturing environment.
The main goal of this function is to lead the Global CMC Support team for Coagulation Factors (complex proteins) within the Biologics Global Stewardship team. The Biologics Global Stewardship team is responsible for shaping the product and process strategy of Shire’s commercial biologics portfolio and supports the Biologics Operating Unit in the production, release and Life Cycle Management activities of late phase and commercial products.
Essential duties and responsabilities
Lead a team of approximately 8 to 10 Global Product Leads, Analytical Product Owners and CMC leads each responsible, for one or several products
Create a high functioning team, holding team members accountable for performance, and mentoring/coaching as needed. This includes recruiting new team members and developing the team’s competencies.
Responsible for the adequate planning and execution of the product strategy of the overall portfolio
Ensure technical rigor of team deliverables and provide broad life cycle management oversight to the team
Responsible for communicating the project status and risks to Technical Services leadership, governance bodies, line management, functional areas, and sub-teams
Act as Technical Services representative of the Complex Protein executive branch within Technical Services product and project governance structures
Direct the LCM (Life Cycle Management) manufacturing process and method activities at a global level by defining strategy and providing an executive road map for their implementation
Provide adequate SME (Subject Matter Expert) support, escalation and prioritization of major process and methods investigations
Ensure Knowledge Management is captured and shared across the different facilities, in close collaboration with local TS Heads, and evaluate areas of harmonization
Ensure CMC (Chemistry, Manufacturing and Controls) strategy development delivers on the following:
Maintenance of continuous supply of commercial products
Ensure that lifecycle initiatives for products are planned and implemented
Ensure CMC strategy to support regulatory filings for product launch and to enable market expansion
Ensure plans and implementation to achieve post-marketing and regulatory commitments
Education & Experience
BSc degree in a scientific discipline with at least 15 years or relevant experience, MSc with at least 10 years, or PhD with at least 5 years of relevant experience in large-scale biotechnology manufacturing including fermentation, cell culture, purification and finishing drug operations
Several years of technical management experience, resource and budget management and strategic development experience
Excellent knowledge and experience with biologics process development and GMP manufacturing support, including cell culture, protein capture and recovery, chromatographic purification, filtration, UF/DF, and drug product formulation, etc.
Demonstrated leadership and capability for strategic analysis and issue resolution
Organizational skills working in a matrix environment
Passion to innovate and find solutions for complex issues
Excellent knowledge of biologics development and manufacturing related scientific disciplines
Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:
Be Results Oriented
Be An Excellent Manager of Self and Others
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. at https://youtu.be/ly_8oO-iJeU
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
In Austria , we are legally obligated to mention the minimum salary for this position: based on the local collective agreement, the salary for this position is € 4.094,41 gross per month (full-time). However increased payment is possible.
If the incumbent is sitting at the Neuchâtel site, the salary range will reflect the Swiss market value.
We are looking forward to your application.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.