Franz Josef Hack
Associate Director Gmp Management Cmc Drug Product @BioNTech SE
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WORK HISTORY
Associate Director Gmp Management Cmc Drug Product @BioNTech SE
Act as CMC Drug Product Lead for multiple RNA-based clinical programs (Phase responsible for end-to-end CMC strategy including control strategy design, external manufacturing governance and cross-functional alignment across development, quality, regulatory and clinical operations in a global matrix environment.
EDUCATION
Texas Tech University Health Sciences Center
Diplom-Pharmazeut, Pharmaceutical Research
Friedrich Schiller University Jena
Doctor of Philosophy - PhD, Pharmaceutical Technology
An Najah National University
Pharmaceutical Toxicology
Approbation zum Apotheker
Approbation zum Apotheker
Friedrich Schiller University Jena
Diplom-Pharmazeut, Pharmazie
ABOUT FRANZ JOSEF HACK
CMC professional with several years of experQse in leading RNA-based drug product CMCstrategy and external manufacturing for global clinical programs (Phase at BioNTech SE.AcQng as CMC Lead Drug Product, responsible for end-to-end program-level CMC strategy,including control strategy design, external manufacturing governance and cross-funcQonalalignment across development, quality, regulatory and clinical operaQons.Experienced in leading global CMO/CDMO networks, managing CMC risk across mulQ-siteclinical supply chains and contribuQng to IND/IMPD regulatory strategies under EMA/FDArequirements.Strong track record operaQng in matrixed global environments (EU, US, China) combiningstrategic CMC leadership with hands-on technical oversight across RNA-based therapeuQcs andemerging mAbs and ADCs.
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