Quality Coordinator Analytical Lifecycle Coordinator (f/m/d) - limited for 18 months


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Job Description

About the role:

You will be working as part of a bigger expert team to support the QC labs with project-related method validations. Affected methods are diverse and require a high level of method validation planning and a good general knowledge of chemical and biochemical methods.

How you will contribute:

  • Act as interface between R&D, Analytical Development, plant project management, QC laboratories, QC analytical lifecycle teams, and external contract testing labs to implement QC tests required for a pipeline product to be manufactured for clinical phase II/III and commercial launch
  • Act as a project manager within Quality Control Vienna to ensure timely execution of all required method implementation/validation activities
  • Write protocols and reports for method validations
  • Manage activities to support project milestones
  • Support and collaborate with the project management team and other internal departments
  • Work closely with QC testing labs during the execution of the validation/qualification work by the QC laboratory
  • Support analytical laboratory investigations during method validation
  • Work in close collaboration with QC Scientists who support QC labs with analytical method validations and method lifecycle activities for already established analytical methods
  • Coordinate method implementation at external contract test laboratories
  • Close collaboration with other QC Analytical Lifecycle teams focusing on other methodologies and Analytical Instruments
  • Close collaboration with R&D and product team

What you bring to Takeda:

  • Master / Ph.D. in natural sciences (analytical chemistry, pharmacy, technical chemistry, molecular biology, etc.) or equivalent relevant experience
  • Knowledge of regulatory requirements concerning analytical test methods (ICH/EP/USP)
  • Knowledge of requirements regarding analytical method validation and critical reagent qualification
  • Knowledge of GMP requirements
  • Strong communication and project management skills
  • Hands-on experience with analytical method validations, especially within the GMP environment
  • Expertise with bio-analytics and excipient analysis: clotting and chromogenic assays, total protein analysis, HPLC
  • Statistical knowledge and expertise in data analysis
  • Good IT skills (MS Office, MS Teams, Minitab)
  • Analytical thinking and continuous improvement mindset
  • Target-oriented team-player with a high level of independence
  • Fluency and technical writing skills in German and English

What Takeda can offer you:

A competitive remuneration package with a minimum salary of € 3.389,68 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary depends on your professional experience and qualifications.

additional Benefits:

  • Family-friendly company environment; Support with parental leave, dad month, Bilingual company kindergarten
  • Work @ home depending on the position/department
  • Comprehensive training programs
  • In-house job rotation program
  • In-house Canteen with discounts or meal vouchers
  • Works council (events, festivals, shopping vouchers, etc.)
  • Employee Referral Program
  • Employee Recognition Program
  • Takeda Resource Groups
  • Medical checkups
  • Free vaccination program
  • Fitness Center
  • In-house cleaning service

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

Locations

AUT - Wien - Lange Allee 24

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


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