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Ensure efficient, compliant and timely management of CPP (Certificate of Pharmaceutical Product) submissions and legalization activities as central coordinating function within GRA; Provide transparent tracking, prioritization and status of workflows
Use all imaginable chemistry tools and methods to develop and optimize commercial process for selected drug substance route (photochemistry, biocatalysis, flow chemistry, electrochemistry, on-line analysis/PAT, high-throughput experimentation, structural
He/She will support the QA program to assure the accuracy and quality of scientific data submitted to regulatory agencies in support of new drug applications and/or biological licensing agreement applications. The R&D QA Manager will collaborate and
This is an exciting and challenging role where you will have technical ownership of commercially launched products and new product introductions to the site (spanning developmental studies and clinical manufacturing up to validation and
Provision of scientific and technical leadership to multidisciplinary teams to achieve corporate goals in challenging research projects within early-stage biologics drug development. Establishing and managing research projects as project scientist;