Shire (Senior) Manufacturing Scientist Technical Services Plasma Vienna m/f in Industriestrasse 131 (Baxalta), United States

About the job:

This expert function is responsible for controlling the process stability, evaluation of any impact on product quality, technical problem solving, and yield improvement. The manufacturing scientist supports our manufacturing and quality partners with process and product know-how and statistical expertise and sets

preventive measures to assure stable processes and sustainable product supply.

Responsibilities:

  • Monitoring, controlling, and improvement of the manufacturing processes of assigned products

  • Identification of process monitoring and yield trends and development of consequent measures to ensure stable manufacturing processes and yield improvement

  • Lead or assist in deviation, complaint and failure investigations, product impact investigation, and root-cause analysis

  • Evaluation of changes (manufacturing processes, analytical testing, and materials)

  • Product related review and approval of manufacturing and validation documents

  • Support of authority submissions and responses to authority requests with process expertise and data analyses

  • Quality by Design for legacy products, update of PFMEAs, development of control strategy

  • Representation at internal and external authority audits

  • Best-practice sharing with local and global teams

Skills you need:

  • University degree in Biochemistry, Biotechnology, Biostatistics, Biology, Chemistry, Pharmaceutical Technology, or similar qualification

  • Excellent communication skills (written and verbal) in German and English, including experience in presenting complex topics in front of multidisciplinary audiences

  • DFSS certification, Black Belt preferred

  • Experience in technical problem solving and statistical process control

  • Solid working knowledge of current GMP and ICH guidelines

  • Innovative and creative thinking

  • Team player with excellent interpersonal skills and capability to influence and drive change agendas without formal authority

  • Ability to take the initiative and work independently while developing and maintaining strong communication with the stakeholders

Company Insights https://youtu.be/ly_8oO-iJeU

Your application should include motivation letter and CV. Remuneration corresponds to the respective classification according to the collective agreement. The minimum salary for this position is € 3,065.25 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.

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.