Jason Candreva, Ph.D.

▪ Oversee programs and personnel for timely completion of projects, coordinating analytical activities with CRO ▪ Independently write and review analytical sections in regulatory submissions including BLA, IND, and IMPD ▪ Direct experiments for characterization, comparability, elucidation of structure, variants, and forced degradation ▪ Develop, improve, and implement platform methods for release/stability and characterization of products ▪ Collaborate with QC in analytical method implementation, qualification/validation, and method transfer ▪ Serve as technical expert to assist in analytical investigations, deviations, and assay troubleshooting ▪ Act as SME for several techniques: ELISA, U/HPLC (SEC, RP, IEX, HIC), CE-SDS, iCIEF, Glycan, DAR, Free Drug, peptide map, native/reduced mass spectrometry (LC-MS), CD/FTIR, DSC, SEC-MALS ▪ Author and review analytical documents including protocols, reports, procedures, and certificates

▪ Developed analytical protein separation methods for release and stability of biopharmaceutical drug products ▪ Worked with a variety of protein therapeutics: mAbs, fusions, bispecifics, multispecifics, ADCs, AAVs, Fabs ▪ Served as SME for several techniques: LC-MS, SEC, RP, IEX, iCIEF, CGE-R and NR, Glycan Analysis ▪ Developed and led technology transfer of a novel LC-MS identification method to CRO for FIH batch release ▪ Authored iCIEF boilerplate method for in-process, analytical development, and characterization departments ▪ Established method development workflow using analytical quality by design (AQbD) software ▪ Guided colleagues on design-of-experiment (DoE) plans for efficient optimization using statistical analysis ▪ Operated and maintained unique LC method development system for DoE and column screening experiments ▪ Authored method protocol documents for use in qualified, CRO, and commercial laboratories ▪ Qualified methods by designing and executing phase appropriate validation experiments and compiling reports ▪ Managed and coordinated summer intern and co-op program for entire Biologics Development Department

Early-phase Method Development & Characterization, Biologics Development

- Protein purification of alpha-synuclein and beta-amyloid, utilizing purification techniques including PCR, molecular biology, bacterial cell growth and protein expression, FPLC, size exclusion chromatography (SEC), and anion exchange chromatography (IEX). - Characterization of peptide aggregation states utilizing Thioflavin T Fluorescence, Native and SDS-PAGE, Western Blots, immunohistochemical dot blots, circular dichroism (CD), and transmission electron microscopy (TEM). - Uncovered synergistic effect of beta-amyloid and alpha-synuclein co-aggregation by stabilizing toxic oligomeric species, indicating a link between Alzheimer's and Parkinson's diseases. - Developed a peptide probe for the detection of toxic beta-amyloid oligomeric intermediates in the pathology of Alzheimer's disease. - Development of novel dual-peptide self-assembly system derived from beta-amyloid, including characterization of resulting biomaterials using FTIR, X-Ray Diffraction (XRD), and Dynamic Light Scattering (DLS).

- Explore novel genes to increase accumulation of triacylglycerol oil in plant vegetative tissues. - Extract mRNA to isolate certain genes for construction of expression vectors and silencing RNA strategies. - Transform plants to alter gene expression in A. thaliana and N. benthamiana to meet accumulation goals. - Published two second author papers - Perform thin layer chromatography (TLC) to separate plant lipids in the analysis of samples from collaborators. - Operate Agilent GC/MS equipment to analyze fatty acid profile of triacylglycerols.

- Develop and maintain two chemostats (New Brunswick Bioreactor) to produce isobutanol fuel from biocatalysts. - Utilize PCR, ligations, restriction enzyme digests, and DNA purification technologies to create vector constructs. - Experimentally design electroporation and conjugation protocols to transform a unique bacterium, A. ferrooxidans. - Propose RT-PCR experiments and enzyme kinetic assay protocols to verify mRNA transcription and protein activity. - Operated Shimadzu GC/MS equipment to detect levels of isobutanol and isobutyraldehyde production.

- Optimized PCR reaction to amplify GC-rich human FGF2 gene. - Utilized restriction enzyme digest to clone FGF2 and GFP into a protein hydrogel construct previously developed. - Developed novel protocol utilizing spectrometry to investigate the erosion of GFP hydrogels. - Proposed that erosion could be facilitated by inducing hydrogel cleavage by including proteases in the surrounding buffer. - Achieved 6-fold increase in hydrogel erosion in fetal bovine serum buffer. - Improved His-Trap affinity chromatography purification protocol to increase protein throughput. Advisor: Prof. Scott A Banta

Worked as a research assistant developing a salicylic acid drug delivery system using cross-linked hyaluronic acid hydrogels. The concentration of salicylic acid needed to prevent bacterial growth was determined. The drug was encapsulated in cross-linked hyaluronic acid hydrogels, and the diffusion rate of the drug out of the gel was characterized. This project was used as a senior thesis for Stony Brook's Honor's College. Advisor: Prof. Miriam Rafailovich

Worked to develop an alternative fuel utilizing a base catalyzed transesterification process to convert waste vegetable oil (WVO) into neat biodiesel. Performed cost analysis for the system, including utilities, waste treatment, wages, equipment, and return on investment. Worked with a team to optimize plant conditions to improve operation and minimize costs for the following units: heat management, methanol recovery during and after reaction, post reaction phase separation, product purification, and overall control of the system. This project was used as a thesis for my undergraduate Senior Design Project. Advisor: Prof. Devinder Mahajan

Prepared cosmetic creams utilizing small scale batch formulations and high shear mixers. Gained experience in a GLP environment, documenting results and following proper laboratory safety measures. Performed stability tests on cosmetic products using instruments such as a rotational viscometer and pH meter. Responsible for completing weekly stability reports for new product development.