Prepare high-quality scientific and technical documentation, such as reports, risk assessments, and development packages for internal and external (e.g., Quality, Regulatory Affairs, CDMOs) With an experienced team comprised of around 200 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process. * Lead technology transfer activities of large-scale GMP manufacturing processes, including process characterization and support of validation and regulatory submissions * Contribute to global regulatory documentation (e.g., CTD, IMPD, IND)
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