Dr. Bettina Hartlieb

-Lobal and local CMC program oversight of all analytical development requirements -Leadership of AD sub-teams, mentoring and training of junior ADRs, collaborating in global cross-functional teams -AD budget tracking, CTO management, resource and timeline planning, risk mitigation strategies -Ownership of analytical control strategy (QbD), release and stability specifications -Authoring of analytical related regulatory submission documents and responses to health authority questions (BLA, JNDA and EMA)

-Interface function for int. and ext. stakeholders for analytical lifecycle management of commercial products -Global collaboration in cross-functional matrix teams -Support of OOS investigations and design of comparability studies -Impact/risk assessment for changes to raw materials, manuf. processes, specifications (incl. JoS), and methods -Lead of GMP method transfers -Authoring of analytical related submission documents and responses to health authority questions (FDA, Health Canada, EMA, PMDA...)

-Interface person for analytical support across Technical Operations (AD, CMC, Global Quality, Quality Control, Regulatory, Manufacturing) -Analytical method improvement throughout the product life cycle and OOS investigation support -Lead of analytical comparability studies and specification strategy -Authoring of analytical chapters and providing responses to health authority questions resulting in successful EMA, JNDA and South Korea approval

-Lead of analytical method transfer (ADA assays) to external CROs -Lead of outsourced immunological research projects -Project management (including PM-tools), support of budgeting and accrual procedures and advanced presentation skills -Working in cross-functional teams for product development projects to meet regulatory requirements -Selected technical skills: multiple assays for immunogenicity assessment of recombinant proteins or AAV-based gene therapies

-Lead of exploratory projects for non-IV Hemophilia therapy including project presentations/reports -Performance management and supervision of employees -Planning, development, performance and analysis of experiments under GLP/GMP and safety guidelines -Excellent teamwork and very good communication with suppliers, ext. collaborators, support and sales representatives

-Research project: Structural and functional characterization of novel CC2D1 complexes regulating endosomal budding processes / 4 publications -Supervision of master´s and PhD students -Protein expression (mammalian cells, insect cells and bacteria) and protein purification (HPLC) -Characterization of proteins and protein complexes by various biophysical and biochemichal methods

-Research project: Characterization of NP-VP30 interaction of Ebola virus using a cell based infectious virus like particle (iVLP) assay / 3 publications -Supervision of master´s and PhD students

Thesis: Functional analysis of Ebola virus VP30 protein based on the crystal structure of the VP30 C-terminus / Thesis and disputation with Summa Cum Laude / 4 publications / Supervision of master´s students

Main Subjects: Virology, Pharmacology, cell biology