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Shire Senior Scientist with a Focus on Development of Biopharmaceuticals (f/m) in Industriestrasse 72 (Baxalta), United States
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.
Purpose of the position:
To lead, manage and co-ordinate projects in the area of product and process development for early and late stage products
To manage numerous stakeholders and complex situations while working in an international matrix structure
To provide expertise and lead internal lab study design and execution for critical investigations
To take ownership of and develop methodology for the High-Throughput instrumentation in the Formulation, Fill and Finish area
To support development of drug products and upscaling for full-scale routine processes
As project lead and representative, taking responsibility for coordinating the output of cross-functional teams intended to bring our products to full commercialization
Planning, execution and documentation of studies for formulation development incl. product stability
Planning, execution and documentation of studies for process development and process optimization in the Centre of Excellence for Formulation, Fill, Finish
Supporting technology transfer and scale up activities for DP processes, as well as providing support to manufacturing
Authoring/Reviewing CMC sections for new process/product regulatory approval
Providing technical assessment on continuous process improvement initiatives and critical investigations
Serving as subject matter expert for cross-functional project teams including due diligence & integration support
At least a Master's level degree with a (bio-) technical focus
DP formulation development experience (screening, stability, stress tests, etc.) would be ideal
Preferably DP manufacturing experience (fill/finish unit operations)
Project management skills would be highly appreciated, as well as the ability to manage complex situations and numerous stakeholders while working within an international matrix structure
Skills and previous experience in design of experiments and statistics
Highly desirable qualities include solution-focus, assertiveness, professional integrity and the ability to work independently and make effective decisions
Good knowledge of English is a must ; basic knowledge of German
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.
The minimum salary for this position is € 3.163,33 gross per month (full-time); increased payment is possible. We are looking forward to your application.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
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.