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MS&T Specialist (m/f)

Date: Jan 11, 2019

Location: Ulm, DE, 89079

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.  Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.  This is how we improve health and enable people to live better, healthier lives.  Join us on our journey of growth!

Job Description

 

Initial during qualification phase of MS&T:

  • Active participation in qualification tasks like risk analyses, documents preparation and system tests for equipment
  • Subject matter expert for qualification matters (documentation, execution etcCoordination of internal and external resources to make sure qualification is on time and on target

 

Routine operations after qualification phase of MS&T:

  • Support production activities (troubleshooting, comparability, investigations etc.) with laboratory and pilot scale models
  • Compose and review SOPs’, comprehensive plans and document projects in reports
  • Plan, conduct, document and evaluate relevant studies in the DSP MS&T laboratory
  • Participate in process transfer activities in the DSP laboratory and the DSP pilot
  • Experimentally evaluate new technologies and process optimization in the DSP laboratory and the DSP pilot
  • Participate in planning and qualification of the MS&T pilot facility

Qualifications

 

  • B.Sc. or M.Sc. in Biotechnology, Biochemistry, Chemistry, Chemical Engineering, or technical education and training, with multi-year work experience in biotechnological DSP API manufacturing and / or development
  • Experience in qualification of pharmaceutical equipment or analytical devices
  • Deep technological and scientific understanding of biopharmaceutical processes, scale up and late stage DSP development
  • Experience with continuous process improvement, process characterization and comparability studies (design and execution)
  • Understanding of GMP requirements especially biopharmaceutical quality and regulatory requirements (EMA and FDA)
  • Excellent command of German and English (spoken and written)
  • Experience with matrix operations and multi-culture working environment
  • Teamplayer with excellent organizational and communication skills

Function

Manufacturing

Sub Function

Manufacturing/Operations

Reports To

In process of validation

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.