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Manufacturing Scientist (f/m/x)

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Job Description

As part of a local Process Science team (supporting PrecG/IG, Albumin and A1PI manufacturing), you will be responsible for controlling the process stability, by means of planning, coordination, implementation and documentation of process validations, evaluation of any impact on product quality, supporting technical problem solving teams and yield improvements in the product area of responsibility.

In this position, you will be in close contact with the site’s manufacturing and quality organizations, as well as global stakeholders to ensure an appropriate level of expertise is provided to the site’s operations to guarantee validated, robust and stabile manufacturing processes.

Your (new) Opportunity:

  • Assure that all internal and external requirements regarding GMP, EHS, and safety are fulfilled
  • Assure robustness and stability of Vienna manufacturing processes for the product you are responsible for
  • Main Responsibility:  Planning and execution of Process Installation, Process Performance Qualification (PPQ) and Continued Process Verification (CPV)
  • Quality by Design for legacy products, update of PFMEAs, development of control strategy
  • Support process and yield improvement initiatives
  • Evaluate the suitability of new technologies for the implementation in manufacturing and work with Manufacturing Science and the plant operation teams to ensure successful transition to the manufacturing floor
  • Product related review and approval of manufacturing documents
  • Lead or assist in deviation, complaint and failure investigations, product impact investigation, and root-cause analysis
  • Support of authority submissions and responses to authority requests with authoring, process expertise and data analyses
  • Support quality and compliance of products within area of responsibility
  • Support timely deviation and change control evaluations
  • Best-practice sharing with local /global Process Sciences teams

Your Skills and Qualifications:

  • University degree in biotechnology, pharmaceutical sciences, process engineering, chemistry or related area of natural sciences
  • Experience in the pharmaceutical industry and knowledge of GMP
  • Appropriate professional experience with focus on protein biochemistry, bioprocessing and PPQ & QbD requirements
  • Experience in interacting with regulatory authorities and official bodies (FDA, EMA, etc.)
  • Fluency in German AND English
  • Ability to work in cross-functional teams and take responsibility for projects
  • Knowledge related to Six Sigma, DMAIC, Data Analysis would be a major plus

Als weltweit führendes biopharmazeutisches Unternehmen mit der Mission „Better Health, Brighter Future“ stellen wir uns tagtäglich in den Dienst des Patienten. Unser Herzstück sind engagierte Kollegen – Takeda fördert uns durch Trainings, Job Rotations und Mentoring. Eine ausgeglichene Work-Life-Balance belegen Auszeichnungen (Beruf & Familie, global Top Employer, Great Place to Work), Betriebskindergarten und zahlreiche Benefits (Fitness-Center, Kantine, etc). Einblicke in den Arbeitsalltag bei Takeda finden Sie hier.

Interessierten Menschen bieten wir zahlreiche Möglichkeiten. Geschlecht, Alter, Hautfarbe, Herkunft und sexuelle Orientierung spielen dabei keine Rolle, im Gegenteil: Wir fördern Vielfalt. Wir wenden uns gleichermaßen auch an Menschen mit Behinderung. Im Zuge eines möglichst barrierefreien Bewerbungsprozesses und um Gleichberechtigung zu verstärken, bitten wir Sie in Ihrer Bewerbung alle diesbezüglich relevanten Informationen anzugeben.

Motivierte Mitarbeiter gehören entsprechend entlohnt. Für diese wichtige und verantwortungsvolle Position beträgt das Mindestgehalt € 3 389,68 brutto/Monat (Vollzeit, KV chem. Industrie). Das tatsächliche Gehaltspaket richtet sich nach Ihrer Berufserfahrung und Qualifikation.

Locations

AUT - Wien - Industriestrasse 72

Vienna, Austria

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Manufacturing Scientist (f/m/x)

Wien
Vollzeit

Veröffentlicht am 26.05.2021


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