Shire Analytical Product Owner (m/f) in Vienna, 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 an Analytical Product Owner. 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.
As a key member of the Global Biologics Product Stewardship team within PDTS, the Analytical Product Owner is accountable for the technical continuum of analytical methods and life cycle management strategies for several late phase and commercial products. 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 responsibilities
Owns the analytical control strategy, change controls and risks assessments for several commercial biologics
Manages product specific analytical development plans and provides technical justification of product specifications
Contribute to the continuous improvement of methods based on analytical development plans, and regular review of methods robustness andIPC/CQA capabilities throughout the product life cycle of commercial biologics
Act as an expert in analytical development of biologics, serving as the point of contact of the PDTS subteam for analytical methods life cycle management and analytical support of commercial biotherapeutics
Provide overview of analytical comparability studies for the products and coordination of the involved groups
Authoring/reviewing regulatory filings of CMC analytical sections and provide responses to health authority questions
Accountable for external lab management
Support analytical method transfer plans and timelines, and PV strategy
Represent Shire Process development biologics and analytical development group at authority meetings and calls about analytical questions
Present issues and results at internal and external meetings, publish articles in peer-reviewed journals
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 the analytical support of biologics process development or manufacturing, formulation development, in process testing and characterization.
Knowledge of complex and state-of-the-art methodology for biologics characterization and development of biologic products, including but not limited to, HPLC/UPLC, mass Spectrometry, immunological methods, cell based assay, particulates characterization etc.
PhD preferred, MSc and BSc will also be considered depending on relevant experience
Knowledge of large-scale biotechnology manufacturing including fermentation, cell culture, purification and finishing drug operations
Knowledge and experience with product development and clinical supplies processes
Experience working with Contract Research Laboratories
Knowledge in European, Japanese, Chinese and US CMC regulatory requirements for Biologics would be a benefit
Ability to effectively communicate and network with different stakeholder groups, both internally and externally
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.