Process Development Scientist (m/f) with a Focus on Drug Produ

Job-ID: 500987

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Shire is the new world market leader in rare diseases with more than 50 rare diseases products and programs including select pre-clinical programs within the development pipeline. At Shire, we are dedicated to expanding, building and sustaining leadership across our key therapeutic areas through our extensive portfolio of products, innovative pipeline and collaborative approach to working with diverse partners around the globe. We strive to earn and keep the trust of our patients, their families and physicians. Working together, the possibilities for our patients, healthcare partners and employees are unprecedented, with significant growth potential for our shareholders.

Purpose of the position:
  • To lead projects in the area of product and process development for late stage products 
  • To provide expertise and lead internal lab study design and execution for critical investigations
  • To support development of 2nd generation 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
  • Planning, execution and documentation of studies for process development and process optimization
  • 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


  • Masters 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
  • Research experience, e.g. skills 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; knowledge of German might make it easier to get around, but is not necessary  

Newly combined with Baxalta, Shire is now the leading global biotechnology company focused on serving people affected by rare diseases and highly specialized conditions.These diseases are often misunderstood, undiagnosed and life-threatening. Our 22,000 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.

Remuneration for this position corresponds to the respective classification according to the collective agreement. The minimum salary for this position is € 3,008.38 gross per month (full-time). Increased payment is possible. In addition we offer many social benefits (e.g. canteen, wellness-center, company kindergarten) to mention just a few of them.
We offer outstanding opportunities to committed and talented people. Sex, age, color of skin, origin, ethnicity, sexual orientation as well as a physical handicap do not matter to us. On the contrary: We promote diversity in every field. Company Insights:

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