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 projects in the area of product and process development in the formulation/fill & finish area for developmental and legacy products
- To provide expertise and lead internal lab study design and execution for critical investigations
- 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
Specific tasks include:
- Planning, execution and documentation of studies for formulation development incl. product stability studies
- Planning, execution and documentation of studies for process development and process optimization in the formulation/fill & finish area
- Authoring/Reviewing CMC sections for new process/product regulatory submissions
- Providing technical assessment on continuous process improvement initiatives and critical investigations
- Serving as subject matter expert for cross-functional project teams
Skills you need:
- At least a Masters level degree with a (bio-) technical focus
- DP formulation development experience (Pre-formulation development, excipient/buffer screening, stability studies, stress tests, etc.) would be ideal
- Preferably DP manufacturing experience (fill/finish unit operations)
- Project management skills would be appreciated, as well as the ability to manage complex situations and numerous stakeholders while working within a matrix structure
- Skills and previous experience in design of experiments and statistics
- A solid background of biophysical and biochemical analytics is desired
- Highly required qualities include solution-focus, assertiveness, professional integrity and the ability to work independently and make effective decisions
- Good knowledge of English is a must; knowledge of German is beneficial
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 € 3.163,33 gross per month (full-time); increased payment is possible. We are looking forward to your application.