Craft
The Technical Workbench
The instruments, techniques and systems I work with, grouped by the part of the job they belong to.
Biophysical & Separations
HPLC / UPLC (RP, SEC, AEX/IEX)
●●●●●CE-SDS
●●●●●DLS (Malvern Zetasizer, Wyatt DynaPro)
●●●●●AUC (Analytical Ultracentrifugation)
●●●●○SoloVPE
●●●●●Bioassay & Molecular
ELISA
●●●●●qPCR
●●●●○Plasmid DNA extraction & purification
●●●●○Reference standard lifecycle management
●●●●●Quality & Regulatory
Empower 3 / LIMS data integrity
●●●●●GMP / GLP / GxP (FDA, ICH, USP/EP/JP)
●●●●●OOS / OOT / CAPA investigations
●●●●●IND / BLA CMC authoring
●●●●○FDA inspection SME
●●●●●Method Lifecycle
Method validation & tech transfer
●●●●●ICH stability (Q1A / Q5C)
●●●●●Leadership
Team hiring & mentoring
●●●●●Client / sponsor decision partnership
●●●●●Cross-functional program management
●●●●○Lean Six Sigma (Green Belt)
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