Alice Lee Email & Phone Number

San Diego, Ca, Us

Greater San Diego Area

• Lead for formulation/process development of high-throughput process toencapsulate small molecules into “first in class” PLGA microspheres (small, uniformly shaped and deliverable with a small gauged needle).• Managed interactions with CRO (8 person team) which included project management,experimental design, analytical/ process document review and communication with crossfunctional teams• Core member of new target identification team

Greater San Diego Area

• Project co-lead for 10 person discovery/CMC team for 2 lead ADC internal projects• Lead process development/ formulation scientist for drug substance formulation and process optimization for ADCs• Developed robust gram scale process/ purification to support customer's preclinical studies. • Negotiated scope of work contracts for customer requested ADC conjugations• Member of design team for future cGMP suite for ADC production• Managed 1 FTE

Greater San Diego Area

• Lead for formulation and process development for research projects including antibody/ drug substance/drug product formulation, process optimization and reagents generation • Developed robust and cost-effective conjugation and manufacturing processes for patented platform technology. • Co-inventor of 2 submitted patents regarding novel platform technology• Project manager and technical transfer lead for cGMP drug substance/ drug product manufacturing campaigns • Project manager of vendors providing custom mammalian cell lines • Built and managed the CovX core tissue culture facility (reagent generation, monitored cell stability)• Managed 1 FTE• Formulation/ fill-finish/ raw materials/ supply chain lead for technical transfers to CMO (12 successful manufacturing runs (preclinical to Phase II)).• Project manager for customizing Primary Packaging • Co-author and reviewer for the CMC/ IB sections and technical reports for 5 IND submissions• Designed and managed in-house long-term stability studies for antibody and drug product.• Designed and executed “condition of use” and container closure integrity testing to support preclinical and clinical dosing• Developed analytical methods (90° Light scatter, deamidation assays, UV-Vis, DLS, SDS-PAGE)• Cloned, expressed (bacterial and mammalian) and purified (AKTA and UF/DF systems) antibody conjugates• Characterized antibody conjugates via mass spectroscopy, DSC, osmolality, IEX/ RP/ SEC-HPLC (Agilent) and capillary electrophoresis (iCE)

Greater San Diego Area

• Lead for formulation and process development of drug substance and drug product. Developed chromatographic methods, lyophilization, and aerodynamic characterization method • Fill-finish/ raw materials/ supply chain lead in technical transfers to CMO for drug product manufacture, placebo and vehicle control. • Person-in-plant for the clinical drug product manufacturing campaign• Co-authored CMC section and technical reports for IND submission• Designed and organized stability studies for Phase I clinical safety trials. Designed, managed and executed in-house stability studies for drug substance and drug product. • Developed bacterial host cell that provides cost-effective method of protein induction• Managed 1 FTE

Structural Studies of Histone Chaperones: Anti-Silencing Factor 1 (Asf1) and Nucleosome Assembly Protein (NAP1)

Master Of Science (M.S.) Biology, Biochemistry

Bachelor Of Science (B.S.), Biochemistry And Cell Biology