Process Lead (f/m/x)


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Orth an der Donau blickt auf eine über 30-jährige Geschichte zurück. Wir sind Experten in der Entwicklung, Produktion und analytischen Testung biologischer und rekombinanter Produkte. Durch die Gründung des „Gene Therapy Center Austria“ www.gtcaustria.com in Orth sind wir nun auch Teil einer  Revolution in der pharmazeutischen Industrie - der Gentherapie. Unser Team wächst und dazu brauchen wir kluge Köpfe mit Kreativität und Flexibilität - welches Talent steckt in Ihnen?

About the position:

  • Matrix  leadership
  • Coordination of implementation of production processes in GMP production and in the process of transfer with special focus on a novel viral vector platform
  • Root cause analysis using Six Sigma methodology and risk analyzes for critical process deviations
  • Responsible the ongoing process data monitoring program (statistical process control) and campaign summary reports
  • Support and lead continuous improvement projects
  • Creation of risk analyzes for quality-critical process changes with regard to the impact on the production process or the product
  • Material Qualification
  • Process Validation
  • Technical support for audits, inspections and submissions is also their responsibility
  • The role includes an important Interface role for global and local functions

Skills you need:

  • University degree in Biochemistry, Biotechnology, Biostatistics, Biology, Chemistry, Pharmaceutical Technology, or similar qualification
  • Experience in technical problem solving and statistics
  • Excellent communication skills (written and verbal) in German and English, including experience in presenting complex topics in front of multidisciplinary audiences
  • 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
  • Innovative and creative thinking are a must
  • Knowledge or practical experience as project manager
  • Solid working knowledge of current GMP and ICH guidelines would be an advantage
  • Green Belt certification would also be ideal

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work - life ratio (recognition for work and family, Shuttle Bus Vienna - Orth) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer.

We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.

Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position is € 4.439,01 gross per month (full time, collective wage agreement for the chemical industry). The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.

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, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda 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, a wholly-owned subsidiary of Takeda 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.


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