Senior Manager Drug Development - Cell-Based Therapies

Senior Manager Drug Development - Cell-Based Therapies

Evotec

Göttingen, Cologne, Hamburg or Munich, Germany

Your key responsibilities:

  • Translation of scientific research into drug development until IND-readiness. Securing that drug development of the selected drug candidate is in compliance with the requirements for cell and gene therapy (ATMP´s);
  • Responsibility to ensure regulatory compliance with ICH and EU-GMP, cGMP and GMP for ATMP as required in close cooperation with internal Regulatory Affairs department;
  • Focus on process development and analytical testing strategy ready for transfer into clinical manufacturing (Technology Transfer);
  • Contribution to enable IMPD/ IND submission for cell therapy product;
  • Contribution to establish internal guidance, training and SOP´s in cooperation with Quality Assurance covering late development in cooperation with internal QA-department;
  • Close interaction with research & development teams across different international sites, with Senior Scientists and project management, quality unit and regulatory affairs department as well as internal CMC interface;
  • Lead the interaction with external partners as required for execution of development plan;
  • Major contribution to the development plan for the selected clinical candidate;
  • Support of Senior Management.

Your ideal qualifications:

  • Scientific and Pharmaceutical background with several years of experience in the field of drug development (biologics and/ or cell-and gene therapy), ideally with insight into GMP-manufacturing of aseptic products;
  • Strong background in drug development for late phase development and clinical stage biologics, preferably ATMP;
  • Profound knowledge in GMP for Biologics (preferably ATMP) and IMP production;
  • Knowledge of GCP requirements for IMP would be a plus;
  • Profound knowledge of applying standards and guidelines acc. to ICH and EU guidelines, FDA experience is welcome;
  • High degree of initiative and flexibility, with the ability to deliver results under challenging timelines;
  • Excellent communication skills with the ability to interact professionally with all levels of staff, collaborators and customers;
  • Fluency in written and spoken business English is necessary.

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© EuroJobsites 2022

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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