Supervisor QC Analytical Lifecycle (f/m/x)


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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:

  • Lead a team of approx. 12 QC Scientists who support QC labs with analytical method validations and method lifecycle activities for a broad panel of analytical technologies (HPLC, GC, ICP-OES, AAS, Electrophoresis, Protein Determinations, compendial DS/DP release methods, full spectrum of tests for incoming material test (EP/USP/non-compendial))

  • Assure compliant and timely execution of QC method validations / qualifications for QC analysis method (release, stability) implementation and maintenance

  • Assure that expert statements and investigation actions are performed by the team to support investigations

  • Assure timely problem-solving activities for analytical methods

  • Coordinate method implementation at external contract test laboratories

  • Resource management and planning for the direct team

  • Close collaboration with other QC Analytical Lifecycle teams focusing on other methodologies and Analytical Instruments

  • Initiate and drive continuous improvements or remediation for analytical assays

  • Support local and global harmonization and simplification activities

  • Support of regulatory inspections

  • Collaborate closely with QC management, QC laboratory heads, project management team and other internal departments such as analytical development / regulatory affairs / other Takeda locations and external partners (e.g. CTLs, vendors)

What you bring to Takeda:

  • Master / PhD in natural sciences (analytical chemistry, pharmacy, technical chemistry, molecular biology, etc.)

  • 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

  • Several years experience in leading expert teams

  • Preferentially hands-on experience with analytical method validations, especially within a GMP-regulated environment

  • Open minded, analytical thinking and continuous improvement mindset

  • Willingness to continuously learn and improve

  • Fluency in German and English

  • Strong communication and coaching skills

  • High level of resilience

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.

  • 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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