Daniel Gotleib
Analytical Development & Qc Scientist (Contractor Consultant) at Biotechnology
Based in Boston, United States
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Seniority
Other
Department
Other
Location
Boston
Industry
Manufacturing
Company size
229
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d•••••••@bio-technology.fr
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Background
About Daniel Gotleib
Analytical development and QC scientist with 15+ years of CMC experience advancing innovative rare disease therapies from early to late-phase clinical development. I am based in the bustling Boston/Cambridge Life Sciences hub. My diverse experience includes-Analytical characterization of Drug Substances & Drug Products across modalities -Chromatographic Separations (including method development, qualification, and transfer)-CDMO/CTL testing management & collaborations -Stability Management & Shelf-Life Determination -Specification Setting & Statistical Analysis -Reference Standard Qualification & Management -Life-cycle management -Quality-by-Design/DOE (from analytical chemistry perspective)-Registered Starting Material characterization & management -Technical experience with multiple modalities:(small molecules/oligonucleotide DS), tablets/capsules/suspension/spray-dried dispersion Drug Products, lipid nanoparticles (LNPs), subcutaneous injectables I am also a double graduate of Northeastern University (B.S Chemistry & M.S. in Regulatory Affairs). Currently enrolled in my 3rd NU program, Leading & Managing Technical Projects.
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