Not registered? Sign up for free now.
Responsibility for late stage CMC development projects with a focus on process validation and market preparation
Plan and track CMC (Chemistry, Manufacturing and Controls) activities regarding timelines, resources and costs
Coordination and preparation of internal and external CMC related documentation (study plans and reports related to cell line and GMP process development and process validation, development and validation of analytical methods)
Review of CMC...
Improvement and further development of the existing quality management system
Develop a professional supplier qualification process
Perform supplier qualifications
Life cycle management of QMS-relevant documents
Scientific and administrative coordination of our various cooperations with academic and industrial partners
Internal coordination of work plans with Apogenix' and our partner's scientists
Close interaction with external partners and...
Develop and implement global regulatory strategies (EMA & FDA) aiming for an accelerated regulatory approval process of our lead compound and further preclinical drug candidates
Prepare, review and file documents to health authorities...