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
- Develop validation strategies for a change in data evaluation of legacy methods to state-of-the art data evaluation of biological assays using PLA or slope ratio
- 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
- This position is limited till end of 04/2022
Your Skills and Qualifications:
- Technical or natural sciences background (biotechnology, biochemistry, chemistry or similar)
- Expertise with coagulation, nephelometric and immunological analytical methods
- 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, preferentially expertise with parallel-line assay (PLA) and slope ratio evaluation
- 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
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, company kindergarten) 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 € 3.270,89 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.