Segundo Moises Hernandez-Abanto

240-***-****; acotw5@r.postjobfree.com

PROFILE

Scientist, with experience working in government, academic and biotech industries; with strong background in research, process development, evaluate and optimize new technologies for biologics and/or vaccine product development; cell cultures, protein expression-purification, protein characterization; analytical assays, process development and transfer to manufacturing, media fill, validation and regulatory processes. Excellent team player in cross-functional groups; experience in training/managing junior staff.

SUMMARY

Knowledgeable and experienced to identify, evaluate and optimize new technologies, for improving efficiency of biologics and vaccines candidates characterization.

Substantial expertise in the creativity and leadership to design, process development and optimization; cell cultures, chromatography (AKTA systems, SEC and HPLC), ultra-filtration systems (Uniflux 30 and 120) LC/MS, immunoassays, RT-PCR, microarray, and High Throughput Screening (HTS).

Extensive and diversified research, scientific and technical knowledge in gene identification-characterization; gene cloning, subcloning, transfection; and vector-systems optimization for gene modification, and protein expression in bacteria, fungi, and mammalian cells.

A strong experience in developed analytical bio-separation assays and assemble test equipment, to support the recombinant product development, processes transfer, product manufacturing and product characterization (preclinical studies using mice, Guinea pigs, and macaques models).

Knowledgeable in FDA and patents regulations, analytical methods validation, and expertise in broad aspects of biopharmaceutical CMC functions including DOE, research-development, technology transfer, cGMP standards, production support and IND and BLA regulatory compliance.

Directed of work assignments in a safe manner, according to SOPs, cGLP and cGMP regulations. Assisted to QC and QA departments making changes to validate systems by providing technical and scientific support for re-qualification recommendation and drafting validate systems change requests.

Contributing member of cross-functional project team, responsible for generate and review the submission of two vaccine products to FDA and EU.

Provide highly professional, reliable and substantial expertise to supervise, lead, training and direct scientists, postdoctoral, research, and students in design and execution of projects.

Outstanding rapport with subordinates and all levels of management; strong leadership and people management skills that focus on teamwork.

Experience in reviewing, data analysis and writing scientific-technical reports, SOPs, safety guidelines, CMC regulatory (IND and BLA), grant proposals, and manuscripts for scientist publications.

Knowledgeable in project management and prioritization skills in technical and scientific strategic; safety regulations and tactical functions with proficient planning and effective execution, to adjust analytical alternative and appropriate assays to optimize and validate results.

Successful in oversee projects from planning through completion (research, process development, manufacturing-upstream-downstream, and product release), independently manage and perform multiple projects simultaneously and ability to multi-task and thrive in complex environment.

Substantial creative expertise to develop and execute validation master plans for upstream and downstream process development, for GMP-manufacturing recombinant proteins and vaccines.

Experienced and skillful in design experiment using DOE methodology and perform statistical analysis, evaluate-interpret the analytical results and provide feedback for design improvements.

Expertise in Microsoft Office Suite (MS Word, Excel, Outlook, PowerPoint), Unicorn 5.31, Prism 4.01, R-3.0.1, STATA 8.0, MS Project 2013, and Microsoft Visio 2010 for diagrams and workflow.

PROFESSIONAL EXPERIENCE

Fujifilm Diosynth Biotechnologies (Kalon Biotherapeutics LLC) College Station, TX

Senior Scientist Biomanufacturing, Nov 2013 ? Present

Direct quality and regulatory function for manufacturing operations; and providing scientific guidance to more junior personnel as required.

Lead a group for the development of purification process used for clinical and commercial manufacture of biological products (pDNA, fusion proteins and Flu vaccines).

Lead the media fill operations, establish the protocols, BPRs, SOPs, validation, and final product stability.

In charge to develop protein and pDNA purification process including chromatography, filtration, membrane separation, and validation of viral and contaminant clearance, scale-up, technology transfers to the manufacturing process and validation.

Implement and oversee corrective and preventative actions, validations, inspections, document control, regulatory affairs and problem resolution.

Ensure that design and change control systems are effective, and provide QC/QA review and oversight to design change and new product development projects.

Create study protocols, write studies reports, technical assessments and recommended changes to manufacturing documents SOPs and BPRs. Provide support for lifecycle related activities as required.

Lead and work effectively and collaborate as part of a cross-functional team required. Work on multiples projects concurrently in a highly dynamic environment.

Teach all aspects of bio-pharmaceutical manufacturing including fermentation/cell culture, purification, product formulation, clinical supply, and manufactured product technical and analytical support.

Participate in the planning, execution, and analysis of a wide variety of experiments. Assist in the creation of a manufacturing cell line, development and implementation of biological manufacturing processes, scale-up procedures, and test methods relevant to the processing, formulation, and evaluation of monoclonal antibodies and pDNA for gene therapy.

Oversee supply management area and assist in managing distribution of clinical supplies and development of supply plans. Work close with cross-functional teams to implement projects involving capacity improvements, safety, cost savings and process improvements.

PlantVax Inc. Rockville, MD

Senior Scientist, Jun 2010 ? Oct 2013

Principal scientist and team leader responsible to establish and ensure the CMC aspects of recombinant antibodies, purification process development, characterization, manufacturing, analytical methods development, quality control, and regulatory compliance.

Managing daily activities of lab and manufacture-supported implementing partners; subcontracts, establishes routine communication, conducts site visits and inspections including ongoing data quality assessments and environmental compliance monitoring; maintains up-to-date information and files on the status of partner activities, resources and work plans.

Improving and conducting experiments to perform upstream and downstream processes for recombinant protein expression, purification and characterization; designing, generating and optimizing of gene-vectors for secreted proteins in bacteria, tobacco plants and mammalian cells.

Designing, developing and validate HTS to select and generate recombinant-CHO cells FUT8 and GMD genes knockdown regulated to produce in manufacturing conditions defucosylated recombinant BChE.

Oversee the monoclonal antibodies and BChE recombinant purification processes development activities, technology transfer for manufacturing production and support from early clinical phases test.

Creating batch records, SOPs and protocols for cells cultures, protein expression, purification, characterization; and preclinical studies (using in vitro and in vivo models).

Developing and reviewing SOPs, BPRs, data, establishing cGMP standards, corrective actions, validation protocols, protocols implementation, reports, and manuscripts.

Reviewing, writing and preparing the submission of recombinant products for FDA and working as a liaison, between Department of Defense, NIH and PlantVax.

Managing and evaluating the projects performance and technology transfer process. Development Strategy, technical/project management, personnel resources, budgeting, compliance, safety, logistics, and other company functions.

Reviewing and applying of research grants, scientific proposals and published findings in premiere scientific journals and presented at external scientific conferences.

Supervising and training lab staff, in new techniques and operating instrumentation, to conduct experiments, using GLP, GCP and GMP procedures.

Designing, performing, evaluating and validate pharmacokinetic and protection studies of recombinant-BChE (human and macaque) against organophosphorus compounds in macaque models.

Aeras Global TB Vaccine Foundation, Rockville, MD

Senior Scientist, Jun 2006 ? Jun 2010

Provided scientific leadership, strategic programmatic direction and technical support as needed during the designing and projects implementation phases. Verified accuracy of protocols assays, results and data validation; monitor the instruments operations and validate the performance.

Implemented validation systems to ensure the products follow the IND and BLA-FDA regulations.

Collaborated with other functional groups within vaccine discovery and clinical development to achieve the goals and providing scientific and technical expertise for upstream and downstream manufacturing processes development.

Managed, established, and developed DNA-integration systems; evaluated the protein expression, protein characterization, and product stability studies in the recombinant BCG strains with integrated genes from M. tuberculosis, HIV and Plasmodium species.

Improved and increased the protein expression, using DNA-sequence optimization, recoding and re-designing genes-antigens-vectors to express in heterologous systems.

Wrote, edited and reviewed GLP and GMP documents: SOPs, batch records, and technology transfer documents for recombinant BCG vaccines candidate strains.

Assisted in and oversaw the process development and implement the manufacturing and regulatory procedures for recombinant BCG-vaccine-products candidates and supporting transfer activities into cGMP manufacturing to supply clinical trials.

Designed, developed and validated a HTS based on PCR and DNA-sequence to select recombinant BCG strains with gene-stability, after manufacturing process.

Supervised and trained lab staff in lab techniques and operating instrumentals and carry out procedures in class 2 biosafety cabinets in strict accordance with cGMPs, SOPs and safety guidelines.

Served as scientific advisor staff on recombinant BCG-vaccine product development team to review and prepare the submission of different vaccine products to FDA and EU.

Member of the investigation team charged with performing root cause and CAPA analysis for failures and incidents. Wrote, reviewed data and updated SOPs, lab protocols; worked under GLP and interacted with Quality Assurance (QA) department to review the manufacturing records.

Performed data analysis, interpretation and presentation of work progress on a regular basis at a detailed and participate in multi-site collaborative groups to achieve intended goals.

Supervised and trained lab staff to reach project objectives, direct reports, lab techniques, operating instrumentation, safety procedures and company policies, according to GLP, GLP-like conditions and interacted closely with QA department.

Lead the lab activities: organizes regular meetings, reviews progress reports and assessments, conduct data quality assessments, environmental compliance and monitoring, identifies issues and problems, and facilitates problem solutions by identifying and securing technical assistance and other resources as appropriate.

John Hopkins University, School of Medicine, Baltimore MD

Postdoctoral Fellow, Aug 2003?Jun 2006

Developed, evaluated and validate a new protocol to generate transposon mutants in M. tuberculosis, to identify and characterize genes involved in bacterial survival under stress conditions.

Created, developed and optimized an inducible-expression system to control gene expression in persistency studies of M. tuberculosis in animal model.

Designed, developed and validated microarrays for defined M. tuberculosis mutant analysis; HTS for genotypically mutants and compared the survival of the same mutant pools in animal aerosol models.

Prepared DNA isolation, DNA purification and analyzed over 2000 DNA-sequences data to detect the gene-mutation (insertion of Himar1 transposon into the chromosome of M. tuberculosis).

Established different assays and validation methods to evaluate the efficacies of vaccine candidates by using immunoassays and animal models after exposure to M. tuberculosis.

Wrote, research grants proposals, research reports, and publications in peer-reviewed journals.

Researched, developed, analyzed data, and validated new assays using flow cytometer; fluorescence microscope; PCR; Real-Time PCR; and microarray technology.

Directed in the development and validation of analytical procedures. Calibrated a variety of laboratory instruments under GLP guidelines and follow SOPs to perform test, analysis, and other procedures.

Trained and coached students, visiting scientists and postgraduates on new lab techniques and operating instrumentation procedures to work with M. tuberculosis. Worked in a collaborative environment with scientists providing knowledge support to a variety of projects.

Performed a wide range of complex procedures and techniques including, diagnostic, gene cloning, vectors manipulations, immunoassays, protein sequence analysis, and cells cultures.

Supervised, evaluated and assured experiments were conducted according to cGLP and BSL-3 conditions. Established standards and polices for testing, inspection, and preventive maintenance of lab facilities and equipment in accordance with lab safety regulations.

Medical University of South Carolina, Department: Biochemistry and Molecular Biology

Associate Researcher, Jan 2003 - Aug 2003

Purified and investigated mechanism of action of the antiphagocyte protein (APP1) in the pathogenesis of Cryptococcus neoformans (flow cytometer, cell cultures, human macrophages and mouse models).

Designed and developed new molecular strategies to identify and characterize new genes. Improved the performance of protein characterization studies using ELISA, western blot analysis, confocal microscopy experiments, isoelectric focusing, SDS-PAGE, SEC, HPLC and mass spectrometry.

Organized the day a day lab operations, maintained analytical monitoring equipment, conduct quality assurance test, and preparing a variety of reports and summaries.

Interacted with students, post-doctoral and non-doctoral research technicians on experimental design and laboratory-based methodologies.

Oklahoma State University, Department of Pathobiology, OK

Associate Researcher, Oct 2001-Dec 2002

Responsible for smooth operation of lab facility; duties included monitoring readings, record keeping, troubleshooting problems, test results, and making adjustments as needed.

Researched, developed, and performed, new methods for: gene-identification, expression and purification of dyhydrofolate-reductase and dihydropteroate-synthase in M. avium and Y. pestis.

Developed and validated new technologies to increase the efficiency of gene-PCR amplification, cloning, cells cultures, chromatography (HIC, SEC), HPLC, western blot, ELISA, and DNA-hybridization.

Wrote study protocols, SOPs, reports, manuscripts, grants and scientific proposals. Generated and performed data analysis, interpretation, and presentation of project results.

Designed and assisted in the implementation, established monitoring systems that will provide regular measurements of outputs and results evaluation, validation of equipments and experiments according GLP and biosafety lab level 2.

Centers for Disease Control and Prevention, Atlanta GA

Guest Researcher, Jul 1997 - Sep 2001

Performed different microbiological analyses, rapid microbial detections, investigating out of specification test results and providing lab support for validation and diagnostic systems development activities.

Developed and validated a new scheme for rapid identification of Mycobacterium species based upon PCR amplification of polymorphic genetic regions with fluorescent primers followed by restriction and analysis by fluorescence capillary electrophoresis.

Improved basic and applied studies to develop a new vaccine against M. tuberculosis (new culture-system for expression, purification and characterization of secreted proteins by HPLC, isoelectric focusing, SDS-PAGE, Western Blot and ELISA).

Designed and optimized a molecular diagnostic system to identify mutations associated with anti-tuberculosis drug resistance from human extra pulmonary specimens.

Evaluated, three recognized identification methods (multilocus enzyme electrophoresis, HPLC-mycolic acid profiles and PCR-RFLP) to identify M. abscessus and M. chelonae.

Utilized and analyzed the molecular microbiological techniques, which included DNA extraction, PCR, capillary electrophoresis, PCR-SSCP, spoligotyping, pulsed-field gel electrophoresis and DNA sequence to improve new methods to identify, sub-typing and susceptibility testing in Mycobacterium spp.

Provided technical-scientific expertise and assistance to develop new identification systems to apply in clinical laboratories and health agencies.

Conducted independent research including planning and conducting experiments, data analysis, and peer-reviewed publication of data.

Trained and provided guidance to visiting scientists, in conventional and molecular methodology to identify, sub-typing and susceptibility testing of antimicrobial resistant in M. tuberculosis.

EDUCATION

Ph.D. Pharmacology. University of Sao Paulo, Sao Paulo ? Brazil.

Master?s Microbiology. Concepcion University, Concepcion ? Chile.

Licentiate Biology-Microbiology. Pedro Ruiz Gallo National University, Lambayeque?Peru.

BS. Biology. Pedro Ruiz Gallo National University, Lambayeque?Peru.

JOB RELATED TRAINING

Certification of Attendance: International Annual Chromatography User Group Meeting. EMD Millipore and Merck-Millipore Corporations, Washington DC (2013).

Certification of Attendance: Approaches and Best Practices for Laboratory Compliance. Waters Laboratory Informatics workshop. Waters Corporation, Milford-MA (2013).

Certification of Research Fellowship in Medicine - Infectious Disease: September 2003 to June 2006. The Johns Hopkins University, School of Medicine; Baltimore MD.

Certification of Research Compliance Training: Human Subjects Research, Animal care and use; Conflict of interest and commitment; Course on research ethics and effort reporting. Johns Hopkins University, School of Medicine (Dec 2003).

Certificate of Completion a Course in the Responsible Conduct of Research at the Medical University of South Carolina, SC- USA (May 2003).

AWARDS

Awarded two international patents about discover Mycobacterium tuberculosis Persistance Genes (8 genes). US Patent # 12/016465; European Patent # 08727895.8-2406 (Dec 2009).

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