• Lead the tech transfer of gene-mediated cell therapy for Sickle Cell Disease to CMO for GMP manufacturing• Project manage the commercial production of plasmids and AAV6 vectors as drug substance for the gene-editing platforms for the 2 leading programs clinical development• Create and maintain integrated CMC project/program plans, timelines, agenda, budget, resourcing requirements, rolling summaries to facilitate planning and coordination of deliverables for the company pipelines.

 Project manage the tech transfer and AAV GMP production of 4 concurrent programs for IND submission and clinical trial supplies across 2 CMO manufacturing sites. Manage the assay development and qualification work both internally and with external CDMOs to support drug substance and drug product release testing. Establish and maintain mechanisms to track progress and completion of CMC deliverables and obligations, including contract management, facility management and issue resolution.  Interface cross functionally in prioritizing assigned product support activities.  Identify areas of risk to development timeline, including CMC, clinical operations, regulatory, quality and other contributing departments to drug development.  Create and maintain integrated project/program plans, timelines, agenda, budget, resourcing requirements, rolling summaries to facilitate planning and coordination of deliverables for the company pipelines.  Manage all aspects of program/project team meetings in the assigned therapeutic area(s), including delivery of project/program updates.  Work closely with external parties to understand preclinical and clinical manufacturing work, timelines, and impact to planned development activity.

 Manage the Manufacturing and Analytical Method Transfer campaign from tech transfer, material procurement, assay qualification, process development through GMP production and quality assurance support according to client’s program objectives Communicate regularly as WuXi’s point of contact with clients and ensure WuXi’s alignment with client’s program objectives and milestones  Support strategic planning and technical discussion for negotiation and development of proposals Partner with Supply Chain and Manufacturing/Testing Operations to ensure appropriate scheduling and delivery of products Utilize business and technical knowledge to identify additional services WuXi can provide to clients (i.e. QC testing, stability program, regulatory support for IND and BLA submissions)

 Managed IND enabling preclinical studies and discovery research studies in novel encapsulation stem cell therapy for Type I Diabetes.  Served as Preclinical Lead in a matrixed Product Development Team with interactions with global regulatory, analytical, cell technology, device, clinical, toxicology, CMC quality and project management to develop novel combination cell therapy. Prepare reports, regulatory documents for IND submission and internal research projects. Successfully submitted pre-IND package to FDA for preclinical program and product development of novel combination product. Initiated and managed contracts, coordinates activities with CROs in support of program objectives Managed preclinical development with external collaborators in the areas of advanced stem cell differentiation, novel device design, toxicology and diabetes animal models. Collaborated with Discovery Data Integrity and Biostatistics groups to implement quality oversight on discovery research to ensure compliance with all Janssen standards. Provided preclinical expertise, and strategy, to multi-functional project teams as the preclinical representative to ensure compliance with GLP, GMP, and regulatory guidelines.

 Managed and supported discovery studies evaluating siRNA-nanoparticles delivery for in vitro and in vivo target knockdown and associated inflammation in various tissue types. Designed and conducted siRNA inhalation delivery (intranasal and intratracheal microspray) to evaluate target knockdown and lung inflammation. Managed preclinical team in evaluating the tumoricidal activity of CTNNB1-siRNA in hepato-cellular carcinoma and ovarian tumor models Collaborated with cross-functional programs that included oncology, medicinal chemistry, safety assessment, pharm science, external CROs and regulatory affairs to successfully complete the IND application for CTNNB1-siRNA in HCC. Collaborated with external vendors to maintain the use of various murine models for primary screens and exploratory studies Collaborated with New Iberia Research Center to manage NHP study logistics  Provided surgical expertise in animal model development and in support of in vivo exploratory studies Liaison with WP Imaging for in vivo imaging (micro-computed topography, MRI, ultrasound, IVIS fluorescence/bioluminescence and intravital microscopy) Provided molecular biology technical support: real-time PCR for mRNA knockdown, stem-loop PCR and RNA isolation

 Translational research in optimizing combinational novel chemotherapeutic agents and radioimmunotherapy/ionizing radiation in solid tumor cancers In vivo MRS imaging of Gemcitabine in pancreatic tumor models in murine and human models

 Services rendered for medical marketing and pharmaceutical industries: Investigative reports and brochures, executive meeting summaries, manuscripts/review papers, white papers, slide presentations  Area of expertise: oncology, nephrology, diabetes, HIV/infectious diseases, and rheumatology

 Novel combined chemotherapy with topoisomerase I inhibitors with 90Y-BrE3 radioimmunotherapy in experimental breast and ovarian human xenografts models

 Evaluated the effect of anabolic growth factors (insulin/ recombinant human growth hormone) on protein kinetics in cachectic cancer patients Designed and studied the effect of organ specific chemotherapy delivery in experimental neoplasm models