Anqi Wang, Ph.D. Email & Phone Number

Gainesville, Fl, Us

Gainesville, Fl, Us

Gainesville, Florida, United States

• Oversee QC testing and product release of autologous cell therapy products and mRNA lipid nanoparticle products.• Lead CMC activities, including process development, creation of process control strategy, analytical procedure development and qualification, raw material quality control, stability study design and specification development.• Direct the environmental monitoring and sterility assurance programs within a GMP-regulated facility.• Lead quality event investigations and corrective and preventative actions (CAPA) implementation and manage change control processes to ensure continuous improvement and regulatory compliance.• Support cross functional teams in IND maintenance for multiple clinical trials; collaborating closely with sponsors and clinicians in FDA communications related to CMC activities. • Drive business development initiatives for external clients seeking personalized medicine manufacturing solutions.• Manage quality control and manufacturing personnel training to ensure compliance with industry standards and regulations.

Alachua County, Florida, United States

• Lead cross function teams to enable tech transfer projects of AAV and LV cGMP manufacturing, new product introduction, and process scale-up with strong adherence to timeline and quality.• Drive technical review of facility fit gap assessment, raw material quality, production batch record, SOP and regulatory submission.• Establish process data analysis tools to monitor process performance, present data summary report to internal and external stakeholders to facilitate decision making. • Evaluate and resolve technical challenges, major deviations, root-cause-analysis, corrective action preventive action (CAPA) and support related change control processes with strong focus on quality, risk mitigation and regulatory compliance.• Represent technical team in client meeting to ensure alignment of expectation, timeline adherence and address client requests.• Support regulatory CMC strategies development for AAV and LV platform process rom pre-IND through Phase III production. • Author and review process description control strategy, including batch summary report, PPQ protocol and Continuous Process Verification (CPV) plan.• Support commercial and business development team in proposal review and site selection assessment

Alachua County, Florida, United States

• Lead upstream and downstream process design of multiple viral vector projects to develop robust GMP manufacturing process.• Drive client communication on technical discussion, align project expectation, evaluate risks and effectively maintain timeline.• Review process design proposal, production batch record, data analysis, summary report, deviation report and tech transfer plan.• Work with site leadership in providing timely resolution of project barriers and facilitate critical decision making.• Coach junior project leads on diverse technical and operational skills; engage team members in achieving project goals.

Gainesville, Florida

• Lead a wide range of assay development and testing of gene therapy products related to AAV, AV, LV, BV, and HSV.• Serve as a subject matter expert in cell-based, nucleic acid- based and protein-based assay. • Design SOP and test record, author and review summary report, and lead deviation investigations.• Drive tech transfer internally and externally to ensure the quality and standardization of testing strategy. • Support QC on assay qualification and validations; review qualification protocol and reports.• Represent the assay development and testing team in client meetings to ensure alignment on expectation and timeline adherence.• Train analysts on technical skills and coach junior scientist on career development.

Gainesville, Florida Area

Project1: Determine spatiotemporal epigenetic changes associated with breast cancer progression.• Executed high-throughput assay to determine genome-wide chromatin accessibility and DNA methylation alterations during breast cancer progression.• Established retroviral vector based oncogenic HRAS expression cell line to study de novo epigenetic silencing during cell transformation using single-molecule assay.Project 2: Identify the epigenetic mechanism driving chemoresistance in glioblastoma. • Initiated the genome-wide epigenetic alteration profiling in primary and recurrent glioblastoma cells.•Designed high-throughput single-molecule based assay to evaluate DNA damage repair pathway genes mediated temozolomide chemotherapy drug resistance in glioblastoma.

Urbana-Champaign, Illinois Area

Project 1: Determine the impact of yeast chaperone proteins p23 and Hsp90 on the chromatin remodelers.• Discovered the novel function of chaperones regulation of chromatin remodeler complexes activity using biochemical approaches.• Purified recombinant histone proteins, chromatin remodeler INO80 and SWR1 complexes, and chaperone proteins for in vitro biochemical assays.• Generated modified Hsp90 expression constructs for photochemical cross-linking assay using site-directed mutagenesis to detect Hsp90 bona fide binding partner in vivo.Project 2: Define the impact of chaperone proteins on chromatin motion.• Discovered new role of chromatin remodelers and nuclear actin filaments in mediating interphase chromatin motion.• Successfully visualized actin dynamics in live yeast cells by constructing fluorescent protein conjugated actin nanobody.• Mentored one visiting scholar graduate student and one pre-med undergraduate.

Madison, Wisconsin Area

Project 1: Understanding Epstein-Barr Virus Nuclear Antigen 3 (EBNA3) functions in B-cell lymphomas.• Identified EBNA proteins and their binding partner RBPJ occupancy on cell genome using ChIP-seq. • Unraveled the mechanism of EBNA3 binding specificity through EBNA2 and RBPJ interaction.• Established new model of EBV nuclear proteins regulation of cellular growth and survival pathways through RBPJ signaling and IRF4 signaling.• Executed H3K27me3 ChIP-seq study in EBV transformed cells to identify cellular targets of viral nuclear protein mediated epigenetic perturbation.Project 2: Investigate cell differentiation associated EBV lytic gene reactivation.• Collaborated with a colleague to study cellular transcription factor KLF4 and BLIMP1 regulate latent to lytic switch of EBV, which could be used as potential target for oncolytic therapy of EBV-positive cancers.• Discovered KLF4 binding to the Zp and Rp EBV immediate-early promoters in vivo, which also lead to their enhanced association with activated RNA polymerase II.Project 3: Characterize Kaposi Sarcoma-associated herpesvirus (KSHV) genes essential for cell transformation and survival.• Established inducible cell line for efficient in vitro lytic reactivation of KSHV.• Produced EBV and KSHV virus from lytic reactivated cell lines for in vitro B-cell transformation assay. • Monitored EBV/KSHV infected primary B-cell for virus copy number change in relation to cell viability and transformation.• Cloned various constructs containing minimal KSHV proteins required for cellular transformation to study the function of viral oncogenes in supporting tumor cell growth.

Guangzhou, Guangdong, China

• Cloned and optimized experimental conditions for GFP based vectors in fluorescence microscopy.• Designed and optimized conditions for long DNA fragment PCR amplification.• Assisted on cloning, purification and functional analysis of monoclonal antibody.• Performed phylogenetic study on hepatitis B virus (HBV) genotypes B and C from blood donors with occult HBV infection (OBI) in China.• Assisted in cloning of hepatitis C virus/GB virus-B chimeric virus to infect marmoset animal model for evaluation of HCV vaccines and antiviral drugs.

Doctor Of Philosophy - Phd, Cell/Cellular And Molecular Biology

Bachelor'S Degree, Biotechnology