Alexander Bank
Head of Bioassay Analytical Sciences @Sanofi
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WORK HISTORY
Head of Bioassay Analytical Sciences @Sanofi
US
Manage a 15-scientist Analytical Development Bioassay organization, providing end-to-end analytical support for six Phase 1–3 mRNA/LNP vaccine and in vivo CAR-T therapeutic programs.• Own bioassay strategy and analytical method lifecycle management across development stages, ensuring phase-appropriate methods aligned with CMC and regulatory expectations.• Direct development, qualification, transfer, and validation of platform and program-specific assays focusing on potency, identity, content, and impurity to support DS and DP release, stability, and characterization. Guide OOS/OOT investigations through FMEA.• Serve as primary analytical partner to Process Development (PD), QC, QA, and Regulatory teams to de-risk late-stage development and enable clinical timelines.• Drive automation (Hamilton Vantage, Beckman Biomek) and operational excellence initiatives, improving analytical throughput (over analyzed samples per year), reproducibility, and data integrity for content and impurity methods while reducing assay turnaround by 50%.• Represent Bioassay Analytical function in governance and technical review forums, influencing program prioritization, resourcing, and risk mitigation strategies.
EDUCATION
University of Pittsburgh
Ph.D., Pharmacology & Chemical Biology
Binghamton University
B.S., Biochemistry
SKILLS
ABOUT ALEXANDER BANK
Results-driven CMC Expert with over 15 years of industry experience in analytical method development, qualification, transfer and cGMP validation, with strong adherence to ICH and pharmacopeia regulatory guidelines. • Support Phase 1–3 clinical programs including mRNA-based vaccines and in vivo CAR-T therapeutics, cell & gene therapies (CAR-T cells, NK cells), and biologics (orally delivered). • Proven ability to lead and scale high-performing AD functions (5 - 15 scientists, AD and QC), deliver phase-appropriate and GMP-ready analytical strategies, provide end-to-end analytical support to enable Process decisions and clinical batch release, and facilitate regulatory submissions with analytical CMC sections. • Strong cross-functional leader bridging Research, CMC and Quality to drive analytical readiness and execution in fast-paced, matrixed pharmaceutical environments. • Expertise in developing and implementing methods to establish identity, potency, content, integrity, residuals and impurity profiles for process intermediates, DS and DP samples using multi-color flow cytometry (FACS), ELISA, Western blotting, qPCR, ddPCR, Sanger sequencing and NGS, cell-based reporter assays, enzymatic activity, nanoparticle characterization using NTA and DLS, and dye-based assays.
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