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.
Within PDTS, the Analytical Product Owner is accountable for the technical continuum of analytical methods and strategies for development products.
About the position:
- Expert in analytical development of biologics, serving as the primary point of contact for analytical control strategy and analytical support for development products
- Owns the analytical control strategy aligned with the Shire sourcing strategy for a product or product family
- Owns the analytical development plan for a product or product family
- Represents Shire Process development biologics and analytical development group at authority meetings and telecom for analytical questions
- Ensures a continuous information flow on analytical aspects across Technical Operations (PDTS, Quality, QC, Regulatory, Manufacturing)
- Contributes as part of a team of scientists to guide the development of analytical methods/projects from early clinical development through to submission
- Provides technical partnership to testing laboratories and process development teams
- Manages analytical development plan and provides technical justification of product specification
- Authoring/reviewing regulatory filing analytical sections and responses to health authority questions
- Contributes and signs-off on all analytical chapters in IND/IMPD/BLA/MAA (development analytical methods, justification of specifications, impurities, characterization etc)
Skill you need:
- Analytical development expert with extensive experiences on method development, characterization and analytical strategy in biologics development, served as analytical project lead for clinical and/or commercial products, regulatory agency interaction experiences
- PhD preferred. MS and BS will also be considered depending on relevant experience
- Successfully and succinctly conveys complex information in both written and oral forms
- 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.
- Direct experience with the analytical support of biologics process development and formulation development, in process testing and characterization
- Ideally experience in authoring analytical-related CMC sections of IND/IMPD and BLA/MAA regulatory submissions and experience working with Contract Research Laboratories
- Strong project management skills with ability to deliver results with effective communication with cross-functional stakeholders
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 € 4.094,41 gross per month (full-time); increased payment is possible. We are looking forward to your application.