1. PD: Early and late stage process development, characterization and validation for biological products2. MST: Process scale up, tech transfer and tech support for clinical and commercial manufacturing3. CMC program management for late stage and commercial stage biological products4. GMP manufacturing for phase I clinical supply

CMC management for late stage and commercial stage biological products

● Responsibilities:1. Analytical method development and qualification for biological drug substances, drug products and in-process samples2. Analytical support for commercial process development and biologics manufacturing3. Report/method/protocol writing and review; Supervising and training interns

● Responsibilities: 1. Analytical CMC management and strategy development2. Lead analytical sub-teams and develop timeline and strategy to support CMC development3. Coordinate and manage both internal and external (CMO/CTO) analytical and characterization activities, including method development, qualification and transfer, in-process/release/stability testing, comparability study, critical quality attribute assessment, etc. 4. Lead technical investigations on analytical testing issues/OOS/OOT5. Develop drug substance and drug product specifications6. Author, edit and review sections/documents for regulatory submission: IND and CTAs, and respond to regulatory questions

Department of Process Development Analytics, Biologics Development & Operations● Responsibilities:Analytical method development to support process development and clinical manufacturing of biological products

Biopharmaceutical Services, cGMP lab, PPD, Inc.● Responsibilities:Analytical characterization for biological products; analytical method development and validation; activity assay development for therapeutic proteins.

Division of Drug Product Development - Packaging, Device and Drug Delivery GroupJanssen Research & Development, LLC, Johnson & Johnson● Responsibilities:Formulation development and analytical characterization of therapeutic monoclonal antibody (MAb)

Department of Pharmaceutical Sciences and Center for Drug Delivery and NanomedicineCollege of Pharmacy, UNMC● Research Summary:1. Therapeutic protein modification with biocompatible amphiphilic polymers for enhancing CNS delivery. ♦ Developed and optimized multiple conjugation and purification techniques to produce stable protein-polymer conjugates for therapeutic studies. Experience in the development of multiple therapeutic proteins such as Superoxide Dismutase 1 and Leptin. ♦ Utilized multiple bioanalytical and biophysical techniques to characterize the properties and stabilities of protein-polymer conjugates. ♦ Evaluated in vitro therapeutic potency of protein-polymer conjugates by using multiple bioassays and cell-based assays. ♦ Collaborated with internal and external researchers in the evaluation of pharmacokinetics and in vivo therapeutic potency of protein-polymer conjugates.2. Formulation development of fullerene and fullerene derivatives as novel antioxidant therapies. ♦ Developed and characterized water-soluble nanoparticulate formulations of fullerene and fullerene derivatives. ♦ Evaluated antioxidant efficacy of fullerene formulations in cell models and cell-free models.● 10 authored or co-authored publications; 2 international patents pending; 16 local, regional, national and international conference presentations● Participated in the development of key technology (pluroMAC™ delivery platform) and key product candidate (leptiPOL™) of NeuroNano Pharma, a startup company specializing in protein therapeutics.