QC Scientist (f/m)

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  • Assure GMP compliant and timely execution of QC method validations/qualifications for QC analysis method (release, IPC, stability, process qualification / process monitoring) implementation and maintenance
  • Manage activities to support key projects (e.g. assay transfers)
  • Plan ICH conform method validations / qualifications
  • Write protocols and reports for method validations / qualifications, method transfer and comparability studies as well as qualification documents for standards and reagents, and implementation of assay controls
  • Work closely with QC testing labs during execution of the validation / qualification work by the QC laboratory
  • Lead and drive analytical assay investigations (OOS, CAPA, etc)
  • Knowledge sharing of problems that were found and share solutions to drive continuous improvement
  • Create and review submission documents
  • Plan and document change requests related to analysis methods


  • Technical or natural sciences background (biotechnology, biochemistry, chemistry or similar)
  • Expertise with analytical methods (HPLC/GC, enzymatic/biochemical tests, coagulation tests)
  • Knowledge of analytical method validation and critical reagent qualification
  • Experience in problem solving (facilitation and application of tools)
  • Statistical knowledge and experience with data analysis
  • Knowledge of regulatory requirements concerning analytical test methods (EP/USP)
  • Six Sigma Greenbelt training would be beneficial but is not required
  • Fluency in German and English (sufficient for international teleconference calls)
  • Technical writing skills in English and German
  • Target-oriented teamplayer, problem solving skills
  • Analytical thinking
  • Position is limited until July 31, 2021

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.

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 €3.270,89 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, 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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