Senior Manager MSAT Upstream Processing

Senior Manager MSAT Upstream Processing

Teva

Ulm, Germany

Your tasks:

The candidate (m/f/d) will be a member of the Bio Manufacturing Sciences and Technology group (MSAT) within Teva’s Global Operations organization. This role is designated to lead a team facilitating the handover of production processes from biologics R&D to commercial manufacturing. This includes scale up/scale down of processes, support of process transfers and process validation, optimization and continuous improvement activities.

  • Lead and develop a team of highly skilled and motivated 4 – 5 employees;
  • Take responsibility for timely tasks accomplishment, laboratory safety, qualification tasks and apply continuous efforts on improvements in working processes and lab routines;
  • Support Head of Department in annual & long term work plans design and execution by resources and budget planning/controlling;
  • Design, document and evaluate relevant process improvement, process characterization and comparability studies;
  • Ensure support of production activities (troubleshooting, investigations etc.) by providing validated laboratory and pilot scale models;
  • Take part in cross functional teams, e.g. composed of MSAT, R&D, CMO and commercial operations as an expert handling GMP risk analysis, process transfers and implementation at manufacturing scale;
  • Evaluation and Introduction of new USP technology advancements to improve costs or yields;
  • Implement latest approaches in plain statistics, MVDA and DoE as well as Process Analytical Technologies (PAT);
  • Work within matrix operations and a multi-culture environment;
  • Participate in planning and qualification of pilot facility.

Your profile:

  • M.Sc. or PhD (preferred) in Biotechnology, Biochemistry, Bio Engineering or equivalent or BSc in related disciplines with multi-year work experience in biotechnological USP API manufacturing, upstream processing and/or development preferable in the area of mammalian cell culture;
  • Deep technological and scientific understanding of biopharmaceutical cell culture processes;
  • Understanding of GMP requirements especially biopharmaceutical quality and regulatory requirements (EMA and FDA);
  • Significant experience with process characterization and comparability studies (design and execution) and with large-scale manufacturing (automation and engineering);
  • Excellent command of English (spoken and written) and a good basis of German language with a willingness to learn;
  • Experience in modelling of upstream processes will be beneficial;
  • Strong presence on the lab floor and hands on mentality;
  • Leadership skills combined with self-organized, well-structured solution oriented working attitude with the ability to motivate.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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