Payal Gala

PaxVax Inc acquired by Emergent Biosolutions. • Part of integration process during merger and acquisition of PaxVax by Emergent Biosolutions. • Provided bioassay experimental design and assay optimization for phase II/III, responsible for validating the process and tech transfer to Analytical group according to ICH guidelines. • Characterized and optimized drug product manufacturing processes models including fill/finish process development for biologics/liquid injectable vaccine products. Part of container closure (vials/syringes) selection, manufacturing process (filtration, mixing, fill finish, and logistics) development, scale-up from bench or pilot plant level to GMP manufacturing for Phase III and commercial readiness. • Reviewed demonstration/engineering/GMP run batch records, technical reports, and communicated with CMO. • Assisted in writing interim and final technical development reports supporting IND and pharmacy manual. • Trained and supervised RAs/Sr. RAs with all the projects and experiments, review data and guide for path forwards.

• Assisted in providing Liquid and Powder formulation analytical support for preclinical through Phase III and commercialization. • Handled Alphavirus, Adenovirus and other viruses. Performed cell culture and cell based assays, Colony Forming Unit (CFU) assay, TCID50 Assay/ELISA/PCR. • Developed and performed lyophilization of vaccine product and find novel excipients/ technology to stabilize vaccine products. • Performed physio-chemical techniques like Intrinsic Fluorescence, Turbidity assay, Dynamic light scattering to determine size of the virus like particle (VLP) to support formulation development. • Used statistical software for DOE application to design and analyze various formulations and stability studies. • Performed extractable and leachable studies for DS and DP container closures. • Developed process development troubleshooting and risk assessments of manufacturing and fill-finish sites for DS and DP in collaboration with internal cross-functional groups and external parties CROs (Althea). • Performed several assays to understand thermal folding and aggregation of the VLP. • Performed dialysis to concentrate VLP and determine its concentration using BCA assay. • Performed formulation and stability studies with Aluminum adjuvants. • Performed developmental work to stabilize the commercial cholera vaccine Vaxchora at 2-80 C. • Performs assigned quality control testing based on SOP. • Assisted in writing and revising standard operating procedures and other related GLP/GMP documentation. Wrote technical reports supporting IND.

• Assisted Sr. Scientists for three projects. All the projects involves working with Biomek FX liquid handler. • Performed mouse embryonic stem cell culture and its maintenance (~1000 cell lines). • Extracted DNA from mouse embryonic stem cells for genotyping. • Differentiated stem cells into Neural Progenitor cells and into astrocytes and treat these cells with drugs to see the effect at the genetic level using High Throughput Screening. • Assisted in cytotoxicity studies using High Throughput Screening. Treat stem cells with compounds to see the cytotoxic effect and its analysis. • Assisted in conducting High throughput in vitro assay for cardiomyocyte activity. Differentiate stem cells to embryoid bodies and then to beating cardiomyocytes. Treat these cells with drugs and study drug response. • Performed quality control of embryonic stem cells, differentiated cells using flow cytometry. • Other responsibilities include write SOPs, follow SOPs, manual and electronic data entry. • Maintained lab inventory and organize lab space, etc.

Conducted research on two projects under supervision of Dr. Chen Farhy: 1. To test the selective toxicity of phase 1 and 2 toxcast compounds libraries to dompaminergic neuronal progenitors using a high throughput live cell screening technique and investigate the cellular and molecular mechanism mediating toxicity. 2.To determine the early critical stages of BMP4-induced Glioblastoma Multiforme Cancer Stem cells (GBM CSCs) differentiation and employ in depth transcriptional analysis to identify candidate target genes and pathways for gain/loss of function assays to test their role in GBM CSCs differentiation and investigate the heterogeneity of GBM CSCs.

Human Mesenchymal Stem cells behavior on Collagen, Fibronectin and in 3-D Fibrin constructs. • Efficiently performed 2D cell proliferation and 3D cell proliferation of human mesenchymal stem cells with various conditions to determine cell proliferation and cell spreading morphology. • Performed Immunocytochemistry to see expression of several proteins secreted by human mesenchymal stem cells. • Performed FACs to analyze the expression of various proteins in human mesenchymal stem cells cultured on different conditions. Cloning of human Rheb1, Rheb2 and TCTP into a mammalian expression vector (pCMV-BICEP4). • Searched molecular databases for certain genes, Designed primers, performed PCR, Visualized PCR product on gel, Purified PCR product, performed restriction enzyme digestion and its purification, performed ligation of DNA insert into a vector using T4 DNA ligase, transformation of ligated product into bacteria, single colony PCR. Determining the effect of anti-cancer agents on cancer cell lines using biology phenotype microarrays • Biolog phenotype microarrays coated with anti-cancer agents were utilized to determine their effect on three cancer cell lines C33A, DotC2 and MCF-7. • Cell proliferation assay was performed using MTS assay. • Lead compounds were efficiently selected from above screen and treated with cancer cell lines. • SDS PAGE and Immunoblot was performed to determine the effect of anti-cancer agents on phospho S6 protein to target mTOR pathway.

Assisted Phd student in his project which focused on understanding the role of RAP80-BRCA1 complex in DNA damage repair and cancer using interdisciplinary approaches. • Cloned and purified BRCA1, RAP80 and MERIT40 proteins using chromatography methods under guidance of mentor. • Performed basic cell culture techniques, molecular biology techniques like SDS-PAGE, etc. • Performed protein purification using FPLC (Size exclusion chromatography), affinity based chromatography. • Performed routine lab tasks and assisted other projects.

Developed and maintained relations with the doctors (OB-GYN). Ensured that the information loop with the doctor right from the lead to registration is kept intact Made presentations to the expecting couples and converted them into sales by informing the clients about the benefits and services of the company. Ensured hospital and the doctor pertaining to a client’s delivery receive all the requisite records and updated the client about the developments post delivery. Ensured that all the details are duly filled in at the time of registration along with the payments. Assisted the customer care to ensure that all the required documents are sent to the client and the Head Office. Maintained daily reports and send them before the deadline.