Abdul Wakeel Email & Phone Number

Burlington, North Carolina, Us

Franklin Lakes, New Jersey, Us

• Design of experiment, generation of SOP (CLSI/ISO), sample and reagent testing (flow cytometry), data analysis and generation of report to evaluate analytical performance of new IVD reagents and products.• Gap identification, analysis, remediation, gap assessment report.• Maintain strong understanding of the industry technology, regulatory and quality guidelines and regulations and provide post-market regulatory and quality compliance and product support.• Lead and manage projects, work with cross-functional teams, develop and review procedures, write technical reports, summaries, and analyze test findings.• Participate in project team meetings and coordinate with Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs, and Business Development.

Berkeley, California, Us

• Review and monitor quality assurance policies for clinical research and clinical operations to maintain laboratory compliance with federal guidelines. • Collaborate with cross-functional management and finance team to perform vendor analysis and make recommendations for the selection and procurement of supplies and equipment.• Plan, conduct, and monitor testing and inspection of materials and products to ensure conformance with service and product quality requirements, CAPA.• Provide training for existing as well as new team members to adapt and improves processes to meet quality standards which in turn increases cost-effectiveness and overall productivity.• Implement current and proposed applicable state, federal and international regulations, including CAP/ CLIA, GLP, GCP, GMP, HIPAA, and GDPR. • Coordinate and support on-site audits conducted by external vendors.• Update Machaon’s quality and document management systems.

Santa Clara, California, Us

Completed a one-year Certificate Program in Regulatory Affairs.

• Lead Scientist for product and process development, quality specifications and analytical method development. • Design, develop, and validate assays, maintain quality and manage internal in vitro and in vivo research efforts to implement new technologies, validation, and support technology transfer. • Manage scientists to achieve technical goals, solve technical challenges and foster external collaborations. • Scientist regulatory/quality and a safety officer and provide leadership and guidance on scientific matters and quality systems• Patents: Host Cell Modification with Artificial Endosymbionts Europe 14842177.9-1401 PCT/ US2014053954.

• Supervised and planned assay development and quantification project, optimization, and validation of biochemical and cell-based assays using qPCR, colorimetry, ELISA, immunofluorescence microscopy and flow cytometry. • Developed in-vitro biochemical and cell-based assays for Magnelle labeled therapeutic cells for cell therapy applications.• Designed, optimized and validated colorimetric, fluorescence, and PCR based assays that improved core technology. • Initiated and led antibodies and cell-based assays that significantly increased the productivity and product development.

Denver, Co - Colorado, Us

• Isolated and purified cells from blood, plasma and spleen, cultured CD4+ T cell, and performed CD4+ T cell proliferation assay using CFSE, multicolor flow cytometry, and FACS.• Cloned and subcloned genes in bacterial and mammalian expression vectors, bicistronic retroviral vectors, generated retroviral particles, conducted transfections, T cell infection, T cell stimulation and differentiation assays. • Conducted research on the regulation of T cell signaling in in-vitro cell based and in-vivo models (rodents) of chronic and acute asthma using immunoblotting, fluorescence microscopy, and multicolor flow cytometry. • Developed protein purification protocols and performed immunoprecipitation (IP) and Co-IP to decipher T cell signaling mechanism and pathways.

Galveston, Texas, Us

• Developed molecular diagnostics and bioanalytical assays using PCR, ELISA, immunoassays, electrophoresis, mass spectrometry (MALDI-TOF, LC-MS/MS) and confocal microscopy to examine the immunodeterminants of Ehlichiae.• Developed and established molecular host-pathogen interaction assay models for virulence factor and vaccine target discovery using Yeast-Two Hybrid System and in-vitro chemiluminescence assay in bacterial infection models. • Performed molecular cloning, recombinant, and native protein expression, separation, purification and analysis, proteomics, 2-D gel electrophoresis. • Identified bacterial (Ehrlichia chaffeensis) proteins that target host (mononuclear phagocytes) defenses and cell processes to establish intracellular infection- this knowledge is useful for potential therapeutics development.• Generated preliminary data which resulted in one R01 and one R21 grant (Grants awarded).• Trained and supervised three technicians on molecular biology techniques that generated requested reagents for biochemical and physiological studies.• Invited/presented research on bacterial modulation of host cell processes- transcriptional regulation, cell signaling, and vesicle trafficking as well as mass spectrometric analysis of secreted proteins and their secretion mechanism at International Meetings.

Professional Certification Programs, Regulatory Affairs And Medical Devices

Postdoctoral Fellow, Infectious Diseases

Doctor Of Philosophy (Phd)

Master Of Science (Ms), Environmental Sciences, Microbiology, Chemistry, Biochemistry, Biotechnology, Biophysics, Genetics

Bachelor Of Science (Bs), General Chemistry, Biochemistry, Analytical Chemistry, Organic Chemistry, Zoology, Botany, English