Biopharmaceutical Drug Product Management and CMO Operations

Biopharmaceutical Drug Product Management and CMO Operations

Teva

Ulm, Germany

Your tasks

  • Within this position you will secure internal and external Bio DP development and commercial manufacturing (contractual obligations of the respective CMOs with regard to the supply and quality agreements);
  • You will act as “single point of contact” for the respective CMOs and internal stakeholders (R&D, QA, DP manufacturing Sites) with regards to the relevant products during development and commercial manufacturing;
  • You will be responsible for end-to-end management of Bio DP development and commercial manufacturing;
  • You will be responsible for the development, evaluation, implementation and validation of the drug product manufacturing processes at the respective CMOs (incl. e.g. formulation, aseptic filling, labelling and packaging);
  • You will provide technical support, trouble shooting, investigation and knowledge sharing with regard to Bio DP commercial manufacturing;
  • You will be in charge of CMO development and actively contribute to internal DP development and commercial site allocation;
  • You will be in charge for and Bio DP CoGs monitoring and optimization;
  • You will be responsible for supervision of deviation management, change control management and process optimization during development and production;
  • You will coordinate documents for regulatory submissions (CMC part) and the “annual reports”;
  • You will contribute during preparation of development and production agreements with regard to commercial and quality aspects.

Your profile

  • You have (Bio) Pharmaceutical education (PhD or master degree);
  • You gathered significant experience in the pharmaceutical industry, especially in development and/or production of aseptic drug product, preferred of biopharmaceutical origin;
  • You have profound knowledge in formulation processes, aseptic filling, labelling and packaging with regard to sterile drug product;
  • You are well experienced in regulatory and quality relevant (GMP) environment with regard to deviation management, change control management and submission documentation;
  • You have great interpersonal relationship skills, experience with multiple culture environments as well as matrix structures;
  • You self-motivated are independent, with decision making capabilities;
  • You are willing to travel around 30%of your working time.

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© EuroJobsites 2019

EuroJobsites is a 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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