Senior Scientist Skills

• Developed and transferred analytical methods internally/externally.
• Developed and validated compound-specific analytical methods.
• Coordinated research groups to meet project objectives and managed laboratory personnel involved in performing analytical methods, formulation and stability testing.
• Advanced method validation gap analysis project involving more than 2000 analytical methods, using sophisticated data management techniques to overcome challenges.
• Designed and conducted experiments leading to the development or optimization of various analytical methods for active pharmaceutical ingredients and finished products.
• Applied solid state characterization techniques and analytical methods to investigate issues encountered during late stage development and commercial production.
• Developed and validated analytical methods in support of drug development projects in all stages from feasibility through commercialization.
• Directed innovations group to develop new products, processes, analytical methods, and technology for commercialization.
• Revised HPLC/GC/MS analytical methods of food ingredients; composed new standard operation procedures; solved manufacturing problems.
• Developed sophisticated analytical methods to test various paper properties, such as acoustic emission and visual microscopy.
• Automated/streamlined various analytical methods using automatic liquid handling systems (Matrix PlateMate, Zephyr etc.)
• Developed, optimized and performed troubleshooting on analytical methods for internal application and at CMO's.
• Utilized several analytical methods to identify contamination source and solved many problems encountered in manufacturing site.
• Developed, modified, validated, and performed analytical methods for routine and non-routine analysis.
• Managed technical transfer of analytical methods to manufacturing sites and contract laboratories throughout the world.
• Work with the Quality Operations sites to review/revise current analytical methods for marketed pharmaceutical products.
• Evaluated laboratory operations, validated the technology process, and verified and transferred analytical methods.
• Developed and validated analytical methods using separation techniques for drug substances and solid dosage formulations.
• Complete value steam mapping of change control process for analytical methods and commercialized product specifications.
• Developed, validated, and executed analytical methods to support Animal Health pharmaceutical products.

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• Incorporated six-sigma and ISO-9000 processes and protocol into a wet chemistry semiconductor manufacturing work center including SOP generation and maintenance.
• Investigated downstream process of vaccine production and purification, working with professions in product development, manufacture and quality control.
• Acquired data, interpreted results, drew conclusions, proactively identified and solved problems related to manufacturing process.
• Provided guidance to ensure operations and programs were streamlined, efficient and in compliance with regulatory requirements.
• Implemented and sustained six-sigma projects and visual management to improve best practices quality control processes.
• Implemented reorganization of group with focus on productivity improvement and alignment with core business.
• Developed and implemented HT cell based assay for insecticidal toxin optimization and receptor discovery.
• Gained expertise in operation, calibration and troubleshooting of following water analyzing Instruments.
• Directed the planning, development and operations of Chemical and Biological intelligence programs.
• Implemented and further developed cloning and verification processes based on GatewayTM recombination technology.
• Develop and execute qualification plans to evaluate various coatings for customers and suppliers.
• Developed new policies and procedures that increased the efficiency of laboratory capabilities.
• Used available sequence information, developed assays to pathogens of economic significance.
• Provided technical expertise in chemical separation, quantification, and formulation characterization.
• Established biochemical laboratory to develop products and processes for enzyme-based products.
• Administered contract support for CBRNE laboratories consistently within budget and schedule.
• Led a quality-control team to incrementally improve characterization and quantification processes.
• Initiated exploratory consumer research, defined product improvements and line extensions.
• Facilitated collaboration with academic and contract research organizations (CRO).
• Provide technical advice to laboratory staff and troubleshoot laboratory issues.

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• Developed various immunological based assay system using monoclonal antibodies to monitor the expression of crystal proteins in transgenic plants.
• Secured federal funding for self-written grants, conducted basic research in protein modification with hydrophobic polymers.
• Optimized formulation characteristics in terms of particle size distribution, total lung delivery and protein stability.
• Evaluated a variety of polystyrene surface treatment options to maximize surface adsorption of capture proteins.
• Supervised clinical batch manufacture of liquid formulation and solid protein tablets for clinical study.
• Organized and presented breakout sessions on protein folding for a company-wide process development symposium.
• Aided in defining proprietary formulation strategies / technologies for oral protein drug delivery.
• Assay used in human experimental medicine study to evaluate CSF protein labeling kinetics.
• Created toolbox for the estimation of protein quality and troubleshooting protein functionality issues.
• Provided technical oversight in cloning projects for large-scale protein production and analysis.
• Developed novel reporter gene vectors for improved processing and protein expression.
• Manage cloning projects and protein purification projects outsourced to other contractors.
• Performed purification, identification and characterization of protein metabolites and impurities.
• Isolate and identify antigenic proteins as lead molecules in vaccine development.
• Developed methods for evaluation of antibodies when native protein is unavailable.
• Implemented novel intrinsic fluorescence detection to selectively and sensitively detect proteins.
• Developed or implemented several pulse sequences for protein-drug interaction studies.
• Crystallized and determined crystal structures for numerous protein drug complexes.
• Developed computational methodology for modeling of G-protein coupled receptors.
• Purified proteins from cultured mammalian cells for biochemical assays.

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• Contributed knowledge, experience, and ideas that facilitated medicinal chemistry team work; coordinated projects across multidisciplinary teams.
• Designed and implemented an expert medicinal chemistry system associating statistical relevance with chemical structure modification using graph theory.
• Initiated and led medicinal chemistry program to develop potent inhibitors of an obesity related target.
• Used a medicinal chemistry approach and identified lead candidates.
• Devised and synthesized a variety of medicinal chemistry compounds.
• Supervised radio-labeling for CNS medicinal chemistry group.
• Managed an early-phase medicinal chemistry program.
• Worked closely with both internal and external biologist, CADD, and DMPK scientists as part of integrated medicinal chemistry programs.
• Managed procurement of reagents, equipment, and lab supplies Skills Used Medicinal chemistry, synthetic chemistry.
• Organized literature sessions to coach team members on new concepts and processes in synthetic and medicinal chemistry.
• Played a leadership role in establishment of the new medicinal chemistry group in a start-up company.
• Developed secondary assays to support medicinal chemistry's efforts for the AIPC and the Hedgehog projects.
• Oversee an assay portfolio critical to steering Medicinal Chemistry Programs in the Lead Optimization Space.
• Project: Synthetic medicinal chemistry in the field of immunology and oncology.
• Led a group of a synthetic organic chemist in Medicinal Chemistry Unit.
• Co-authored important patents in the field of CNS medicinal chemistry.
• Contract Research, Synthetic Organic Chemistry, and Medicinal Chemistry.
• Provided scientific leadership and professionalism to multiple medicinal and chemistry projects Provided successful contributions to a dozen of medicinal chemistry projects.
• Synthesized NK-1 antagonists and intermediates on multi-gram scale to support a medicinal chemistry program for depression.
• Proposed and executed multistep syntheses of target molecules to aid medicinal chemistry projects for customers.

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• Designed key targets and supervised one chemistry associate resulting in the synthesis of additional compounds, some with excellent biological activity.
• Designed and synthesized novel small molecule inhibitors of PTP1B, using solution phase parallel synthesis and traditional synthesis techniques.
• Supported industrial fermentation program for advancing synthesis gas fermentation technology for production of fuels and chemicals.
• Created a novel reaction-based chemical library enumeration and tracking tool to represent mixture and parallel synthesis.
• Supervised and mentored chemists responsible for the design and synthesis of therapeutic molecules for biological assay.
• Created first commercial, predictive metabolic simulation model of synthesis gas to ethanol microbe.
• Direct organic synthesis projects for process improvements and manufacture of PanVera drug discovery products.
• Implemented effective use of structure-based design and parallel synthesis to advance project goals.
• Core responsibilities: Timely synthesis of anti-bacterial compounds to support multiple partnered programs.
• Contributed intellectually designing novel synthetic routes for the synthesis of various target molecules.
• Supervised FTE-based contract research in synthesis of intermediates from route design to scale-ups
• Transferred laboratory scale synthesis procedures to in line manufacture of 1m2/min productivity.
• Contributed to chemical synthesis and process scale-up development to support pipeline programs.
• Supported pharmacology assay development through the synthesis of known substrates and inhibitors.
• Coordinated discussion sessions to review synthesis results on a regular basis.
• Oversee related internal and external contract synthesis projects of exploratory compounds.
• Design and synthesis of initiators and terminators for an anionic polymerization.
• Effect of supported oxides over ruthenium catalysts in Fischer-Tropsch synthesis.
• Performed custom synthesis, contract research and chemical process development.
• Designed and executed synthesis of highly water soluble organic photo-initiators.

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• Project Lead in developing lab-on-a-chip products for miniaturized HPLC and LC/MS system including applications in protein separation and gel filtration.
• Author and trainer of several departmental Internal Procedures, Instrument Operating, Calibration Procedures and HPLC training/qualification modules.
• Devised and implemented screening program to evaluate protein binding affinities using immobilized albumin HPLC columns.
• Scheduled preventative maintenance for HPLC instrumentation and performed follow-up calibrations.
• Developed explosives method on HPLC for Military Applications.
• Developed and validated HPLC separations.
• Completed testing and validation of the new Waters Empower software deployment for 60 HPLC systems before scheduled deadline for change management.
• Developed and validated HPLC, LC-MS, and LC-MS/MS assay methods and stability indicating methods for drug substances and drug products.
• Developed HPLC methods for drug potency/content uniformity test, and quantification of impurities and drug degradation products for drug products.
• Developed and validated 7 HPLC methods for assay of API/preservative and estimation of impurities and degradation products in drug products.
• Performed drug residue testing in foods, cosmetics, water and air samples using ELISA, HPLC, LC/MS.
• Performed HPLC, X-ray powder diffraction, single crystal X-ray analysis, thermal analysis, TLC, and FT-IR.
• Develop, validate, and transfer HPLC methods for assay, related compounds, and dissolution for various products.
• Initiated HPLC method optimization analyses on two vaccine formulations; with the focus on improving peak recovery and selectivity.
• Performed method validation of Assay, Dissolution and RS method using HPLC, UPLC Dissolution and UV technique.
• Designed HPLC and HPLC/MS test method characterization and validation plans that were later implemented in several areas.
• Developed and validated a HPLC method for the analysis of impurities up to nine components.
• Extracted BMP-7 from formulation by RPHPLC and characterization of extracted BMP-7 using SEC-HPLC and MALS.
• Train junior analysts on assay methods, HPLC/MS-ESI instrumentation and mass spectral data interpretation.
• Developed the HPLC methods to assess whether AMPK activating drugs modulate cellular ATP content.

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• Design and optimize composite fabrication process to support new product development as well as application demonstration of commercial product.
• Executed research and new product development projects and processes for manufacture of pressure-sensitive tapes.
• Performed market research and competitive analysis, and provided new product development recommendation;.
• Identified industry key opinion leaders and established partnership for new product development.
• Managed multiple, multidisciplinary project teams to deliver new product development projects.
• Used consumer insights to identify strategic research and new product development.
• Assumed Research and Development responsibilities for one New Product Development project.
• Conducted method qualifications and validations to support new product development.
• Prepared documents and stability reports for new product development activities.
• Supported several New Product development projects, consistently meeting deadlines.
• Coordinate new product development project with Contract Manufacturers and Consultants.
• Provided technical support related to new product development, product production, and end use of products for customers.
• Led New Product Development and Technical Services for confectionery dietary supplements, powdered soft drinks, and margarine spreads.
• Support global strategies through new product development & equipment initiatives to drive branding, market share and customer satisfaction.
• Project Manager & Manufacturing Lead * Participate in new product development meetings as Manufacturing Core team member.
• Conducted laboratory studies to define and resolve plant quality issues; conducted research in new product development.
• Championed new product development and commercialization through cooperation with sales, production, and QC departments.
• Optimized the coating processes and worked on new product development resulting in improved product quality.
• Initiated informal and formal stability studies for R&D New Product development department.
• Implemented design control process for new product development for drugs and medical devices.

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• Provided subject matter expertise regarding instrumentation for site-wide laboratories and assisted with interpretation of FDA regulations for laboratory equipment and instrumentation.
• Responded to regulatory agency inquiries regarding product safety and assisted with FDA inspections within drug safety department.
• Supported products in EVSCO veterinary pharmaceutical division, including formulation, manufacturing trouble-shooting and FDA issues.
• Ensured laboratory readiness for and participated during regulatory inspections (FDA) and other external audits.
• Identified, synthesized and fully characterized numerous production impurities to comply with more stringent FDA requirements.
• Ensured laboratory compliance with FDA regulatory guidelines and assessed their impact on products under development.
• Developed and implemented strategies for sustaining products through Application Integrity Policy constraints imposed by FDA.
• Conducted NMR analysis of reference materials and prepared structural characterization documents for FDA.
• Satisfied FDA commitments by completing system validation/qualification activities for CFR Part 11.
• Authored reports for FDA submissions and standard operating procedures for laboratory techniques.
• Provided statistical guidance supporting validation and verification efforts in FDA-regulated industries.
• Participated in responding to an FDA regulatory inquiry and inspection.
• Calibrated and validated equipment used to generate FDA submission data.
• Led process development, verification and validation following FDA guidelines.
• Provided support during FDA audits of departments within Pre-Clinical Development.
• Reviewed and evaluated FDA regulatory requirements for continued compliance.
• Directed FDA submission sequencing projects and implemented GLP requirements.
• Developed validation documentation package for FDA audit of findings.
• Interacted with FDA and other international regulatory authorities.
• Established pharmaceutical testing laboratory for FDA submission data.

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• Implemented an improved scheduling and analysis management effort between government contracting team and their government customers to foster rapid data analysis.
• Developed several imaging algorithms and post clinical data analysis frameworks for reduction of field defects and increase of clinical efficacy.
• Write protocols and reports and review data analysis and interpretation, troubleshooting and scientific oversight of activities and planning.
• Facilitated weekly meetings for data analysis and developing new ideas/hypotheses for metabolic pathway engineering, which improved strain performance.
• Performed animal experiments from design to data analysis, including drug administration, tumor measuring and organ harvesting.
• Designed Excel workbooks for assay set-up and data analysis, increasing productivity and efficiency while reducing time.
• Developed, planned, and executed numerous data analysis related projects or very different natures.
• Design of reliability experiments, data analysis; evaluation of materials for new product.
• Analyzed data using various data analysis software and/or applying quantitative methods using MINITAB.
• Designed and coded stochastic and deterministic models for climatic and atmospheric data analysis.
• Developed models and experimental data analysis codes to support company goals 11.
• Established feasibility of project design, data analysis procedures and evaluation criteria.
• Design and execute experiments, data analysis to identify critical formulation/process factors.
• Advised and mentored colleagues on experimental design, data analysis and interpretation.
• Direct all activities and data analysis with internal teams and academic collaborators.
• Developed modules for performing water quality data analysis in the classroom.
• Performed high-volume data analysis of radar system output for several projects.
• Contributed to real-time-release testing activities, process understanding and data analysis.
• Collaborated with IT to facilitate tool development for data analysis.
• Managed assay development, automation set-up and data analysis.

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• Developed co-culture assays to characterize cholesterol transport functionality from human samples from late development clinical trials.
• Performed analysis and data interpretation to profile lead molecules and candidates for clinical trials.
• Developed adjudication standards for clinical trials and supervised implementation for clinical trial execution.
• Provided document quality assurance for clinical trials assigned to other departmental staff.
• Conducted clinical trials with Cleveland Clinic and University Hospitals of Cleveland.
• Led investigation and analyses of clinical trials for competitive products.
• Subject Matter Expert for database (Oracle Clinical / Integrated Review) review for proactive signal detection of ongoing clinical trials.
• Interfaced with upper management, Marketing, and Regulatory Affairs through project updates, focus groups, and clinical trials.
• Interpreted and understood biological data to support drug candidate's progression to Human Clinical trials (Phase II POC).
• Received a patent for synthesizing a lens polymer, moved prototype through clinical trials, and transferred to manufacturing.
• Designed and developed studies for identifying mechanism of action (MOA) of drug-related adverse events in clinical trials.
• Coordinated clinical trials, pilot studies and developed commercialization options in dairy milk and buttery spread products.
• Team evaluated late stage experimental compounds in support of clinical trials and project teams in these models.
• Developed and enhanced the process for an antidepressant drug and delivered large quantities for clinical trials.
• Supported Registration Stability Studies, Phase I, Phase II, and Phase III clinical trials.
• Core member in the development of one lead compound PL-3994 in clinical trials for the CHF project
• Design and synthesized PHX1766, a novel NS 3/4a inhibitor, entered Phase Ia Clinical Trials.
• Helped to develop a cell-based wound therapy and bring said therapy into phase II clinical trials.
• Transferred processes to pilot plant scale for clinical trials (Phase I & II).
• Implemented T cell immune monitoring as end-points in early or late stage clinical trials.

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• Synthesized several small molecules for different projects and experienced in antibody drug conjugates.
• Synthesized several potent small molecules in Erectile dysfunction.
• Developed degradation assay for Androgen-Independent Prostate Cancer (AIPC) identified as key assay for profiling small molecules.
• Synthesized approximately 65 small molecules to support medicinal chemistry programs with sales value of roughly $1 million.
• Provided marketing and tech support for kits, antibody conjugates, and antibodies against small molecules.
• Performed sample preparation and analysis of small molecules in tissue samples for DMPK studies.
• Conducted hit to lead and lead optimization of small molecules.
• Conducted structural elucidation of small molecules with MS data.
• Quantified pharmaceutical small molecules using LC-MS/MS in plasma.
• Performed Project Management responsibilities for an electronic data review and archive project within Bioanalytical/Small Molecules Division.
• Synthesized unnatural amino acids and building blocks, generated small molecules leads for several projects.
• Optimized assays and techniques for highthroughput small molecules inhibitors screening.
• Synthesized small molecules library and important building blocks.
• Executed pipeline support through ADME and PK characterization of small molecules and mAb from discovery through early stage development.
• Conducted clinical validation with Mayo Clinic - small molecules, protein biomarkers, and DNA/RNA.
• Created robust UPLC and LC methods for quantitative analysis of small molecules and oligomers.
• Performed LC-MS/MS method development of small molecules using an AB Sciex 5500 QQQ.
• Designed and synthesized small molecules using X-ray crystal structures for neuropathic pain.
• proposed and led group to test small molecules for inhibition of TGF.
• Developed methods for analysis of small molecules, oligomers, and polymers.

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• Led all research phase activities related to the development of new molecular diagnostic assays for food-borne pathogens and quality indicator microorganisms.
• Experienced with cross-functional teams and have the capability to profoundly establish cross-functional collaborations with both in-house teams and external groups.
• Designed and carry out environmental investigations, and collect environmental data that will be used to solve environmental problems.
• Published scientific reviews in peer-reviewed journals about state-of-the-art of company products that can potentially develop new claims for commercialization.
• Evaluated various delivery platforms and developed non-viral drug delivery systems for cancer cell-lines and primary human T cells.
• Coordinated departmental efforts as part of cross-functional scientific teams focused on the discovery of oncology development candidates.
• Analyzed formulations for stability claims, feasibility studies, shelf life determination and qualifications of raw materials.
• Developed computer vision and machine learning algorithms to provide innovative solutions for RF signal processing applications.
• Elucidated mechanism of inhibition by lead molecules in terms of mode of inhibition and reversibility off-rates.
• Devised and implemented strategies for priority setting in terms of targeted areas for intervention improvement.
• Work with colleges and universities to perform research evaluation on educational programs and accreditation systems.
• Liaised with contract research organizations, assisting with resolution of laboratory events and systems development.
• Provided independent oversight and lead asbestos removal and inspection teams prior to demolition of buildings.
• Represented Safety Pharmacology on four teams contributing to delivery of those project compounds to development.
• Led and mentored a cross-functional team towards development of industrially robust 5-carbon sugar fermenting organisms.
• Developed protocols for complex subsystem performance evaluation, established performance requirements for various subsystems.
• Integrated new database systems into laboratory to streamline daily processes and analysis of data.
• Project Engineer for infrared and visible sensor systems for advanced optical imaging technologies.
• Developed dynamic data structures for parallel algorithms running on a shared-address space computer.
• Produced Wavelet transform and SVD based algorithms for automated identification of cardiovascular stress.

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• Optimize protocols with specific chemistry for biological sample preparation to be imaged by fluorescence, ion-milling or serial-block-face scanning electron microscopy.
• Managed cross-departmental characterization and comparability studies to support the transfer and upgrade of a plasma-derived protein manufacturing process between facilities.
• Played a key role in collaboration cross functional groups on drug screening and validation, identified and organized extramural collaboration.
• Developed SAS macros to facilitate automate data management, tabular and graphical data summaries for statistical designs and analyses.
• Served as department representative on cross-functional product launch team * Drafted/executed process development protocols to support final commercial process.
• Work cross functionally with Regulatory, Process Development, and Quality to support commercialization and marketing application filings.
• Work effectively within a diverse team of co-workers and across disciplines ; managing research collaboration and outsourcing.
• Supervised and developed research associates, pursued cross-functional research, and interacted extensively with suppliers and vendors.
• Coordinated internal efforts to identify areas for improvement, and to disseminate best practices across the organization.
• Processed inconsistencies in methodologies across new corporate acquisitions, and developed approaches to meet regulatory requirements.
• Led global financial and technology industrial intelligence tracking, and other hard science/social science cross-disciplinary projects.
• Provided industrial hygiene oversight of Environmental Restoration and Decontamination & Demolition projects across the NTS.
• Enable and direct portfolio-level studies that impact multiple projects within oncology and across therapeutic areas.
• Represented the department in cross-functional project teams to provide technical expertise for drug development.
• Collaborated on research activity across three international sites to exploit emerging structure-property relationship data.
• Interfaced routinely with a cross-functional quality improvement team, stakeholders, and customers.
• Selected for new cross-functional training program for candidates identified for accelerated succession plan.
• Promoted rapid advancement in product development processes via cross-functional collaborations with diverse departments.
• Led cross-functional team to collaborate and share information about predictive methods and modeling.
• Engaged with numerous cross-organizational teams focused on improving company culture and colleague engagement.

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• Developed protocol for Mass Spec based protein identification of Membrane proteins and successfully performed GLP validation required for Regulatory safety studies.
• Developed an ELISA-based assay for drug efficacy studies, performed potency assay analysis and compiled method development report incorporating GMP/GLP guidelines.
• Provided nonclinical Good Laboratory Practice (GLP) safety pharmacology studies to advance compounds in development.
• Write standard operating procedures to maintain GLP documentation relevant to the duties and responsibilities assigned.
• Analyzed biological samples for discovery and development studies in a GLP laboratory.
• Provided timely supervision and coaching to maximize efficiency and ensured GMP/GLP compliance.
• Participate in method development for QA and GLP of experimental keratin-based products.
• Provided small-scale GLP synthetic chemistry laboratory support to bulk GMP pharmaceutical manufacturing.
• Created forms and validated instrumentation and analysis protocols according to GLP regulations.
• Coordinate and execute GLP formulation manufacture and characterization studies and projects.
• Performed laboratory and manufacturing audits to ensure GMP/GLP compliance.
• Managed laboratory operations; purchasing, installation, use, calibration, and maintenance (GLP/non-GLP, CGMP) of equipment.
• Established the scale up route of the lead drug candidate and accomplished scale up (GLP) synthesis for toxicological studies.
• Managed the planning, evaluation, and interpretation of routine and non-routine GMP and GLP laboratory experiments of two direct reports.
• Troubleshooted, developed, transferred and validate multiple cell based and ELISA based assays for GLP, and clinical testing.
• Developed specialized methods for medical device testing, pesticides Pharmaceutical GC/MS testing(QC test using GMP/GLP Standards).
• Established timely and qualified contract work for outsourced GLP studies through partnership with Legal, Procurement and QA departments.
• Experienced with the processes and requirements required for GLP LC-MS/MS method validation, mostly in application to Non-GLP/GLP studies.
• Maintained accurate study data and records and ensured compliance with GLP regulations, SOP and other corporate policies.
• Trained Co-op students on creation of GLP notebooks, data management, animal handling and other scientific techniques.

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• Developed novel animal models and utilized established animal models to support multiple drug discovery projects in the Inflammation therapeutic area portfolio.
• Participated in most stages of antibody drug discovery from candidate selection through to companion diagnostic development for patient stratification.
• Championed three small molecule drug discovery projects for rheumatoid arthritis, from exploratory through lead identification phases.
• Directed worldwide Novartis Oncology lead-finding efforts and spearheaded a novel program entitled New Drug Discovery Technologies.
• Co-organized global meeting leading to a set of recommendations of best practices for fragment-based drug discovery.
• Organized research collaborations with corporate partners and academic institutions to pioneer methods of drug discovery.
• Delivered hundreds of production pharmaceutical intermediates and building blocks for modern drug discovery research.
• Developed novel methods to characterize enzyme/inhibitor complexes that provided unique insight toward drug discovery/design.
• Performed laboratory research to support Cell Therapeutics' oncology drug discovery and development programs.
• Manage site quality control operations for a chemical repository that facilitates high-throughput drug discovery.
• Designed, developed and optimized functional cell based assays for small molecule drug discovery.
• Drug discovery/medicinal chemistry, support multiple lead discovery and lead optimization projects.
• Conducted LDLR lead discovery and molecular pharmacology in cardiovascular drug discovery.
• Developed various biochemical and cell-based assays for drug discovery projects.
• Presented DMPK data in multidisciplinary drug discovery project meetings.
• Provided scientific leadership for drug discovery projects.
• Lead biologist for anti-inflammatory drug discovery programs.
• Parallel synthesis technique for drug discovery.
• Involved in two critical projects in the area of drug discovery for inflammatory diseases (rheumatoid arthritis and asthma).
• Coordinated a project focused on the development of cell lines and cell-based assay systems for partnered drug discovery programs.

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• Designed and implemented Viral Clearance Validation for two proteins for future GMP production resulting in viral reduction below acceptable levels.
• Conducted technology transfer to numerous manufacturing sites for scale up to regulatory toxicology and clinical GMP manufacturing scale.
• Understand laboratory record and documentation practice as well as regulatory compliance and GMP training.
• Supervised purification, formulation and validation of monoclonal antibodies in compliance with GMP.
• Managed, supervised, and evaluated routine and non-routine GMP laboratory experiments.
• Performed GMP and safety inspections of laboratory areas.
• Maintain a GMP environment in laboratory testing
• Coordinate and verify all chemistry laboratory activities such as testing, qualifications, purchasing orders, GMP, Safety, etc.
• Assisted in-house GMP batch production operations of various dosage forms, packaging the finished clinical drug products using batch production record.
• Interfaced with QA and Drug Supply Management (DSM) groups to assure GMP compliance and timely release of products tested.
• Reviewed instrument (re) Qualification documentation packages (IQ/OQ/PQ) prior to their release for GMP use by team members.
• Authored process development reports, provided technical impact assessments of process deviations, and reviewed GMP batch record documentation for QA.
• Prepared, performed, reviewed and compiled protocols and GMP data on pharmaceuticals for Federal review that led to product approval.
• Maintain audit readiness as applicable to site quality procedures and GMP regulations for both internal quality and external customer audits.
• Led cleaning verification program for Fermentation & Purification runs as part of process technology transfer & GMP batches.
• Developed purification protocol for two intact antibodies followed by scale up and GMP production in 100K-class clean room.
• Implemented GMP compliance efforts such as equipment logs, process and equipment validations and cleaning validation efforts.
• Maintained good-manufacturing practices (GMP) by keeping all records pertaining to quality control and safety rules.
• Oversee GMP testings for process/production monitoring, in-process materials, final product release, and stability studies.
• Involved in the conception of GMP facilities for the preparation of clinical batches and small- scale production.

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• Prepared fluorescent-labeled DNA modified polystyrene particles for comparison studies, and completed the study successfully.
• Developed and improved purification processes for protein products used for DNA sequencing technology.
• Developed and validated non-invasive assays for circulating tumor cells and circulating tumor DNA.
• Studied their enzymatic stability, and hybridization properties with complementary DNA.
• Research and development of novel DNA/RNA amplification and detection technologies.
• Established high-throughput automation for DNA sequencing.
• Performed instrument runs to demonstrate that the water used to manufacture the Negative Control was free of residual DNA and microorganisms.
• Developed next-generation Ion TorrentTM beads, and commercially used on the Ion Personal Genome Machine (PGMTM) for DNA sequencing.
• Transferred process to full-scale purification, including a low DNA polishing step to remove traces of residual DNA.
• Led development, feasibility studies, validations, and implementation of Roche's TaqMan DNA Generic Master Mix.
• Recruited to GenVault as the first Scientist, for background DNA/RNA/protein experience and experience as a lab manager.
• Developed FFPE RNA and DNA library preparation methods for high-throughput NGS sequencing, including target enrichment methods.
• Designed and optimized sample prep and amplification assays for detection of infectious disease agents using trans-renal DNA.
• Sample DNA/RNA isolation/purification from various sources (FFPE, blood, bone marrow, various tissues).
• Developed double stranded DNA recovery kit from FTA and plain paper stored blood (GenSolve).
• Performed PBM experiments with plant and microbial proteins to survey their interacting DNA motifs.
• Developed quantitative DNA and RNA molecular controls for external quality control of NAT assays.
• Developed MLE algorithms for copy number estimation as a proxy for DNA quality.
• Evaluate sample preparation methods for DNA isolation from Liquid Based Cytology media.
• Constructed a high complexity 10Fn3 scaffold based DNA library (3x1013).

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• Designed latex agglutination and ELISA-based assays for the detection (and relative quantification) of avian antibodies/antigens.
• Established purification and purity analysis procedures, and developed numerous ELISA assays.
• Performed the qualification/validation of ELISA assays for release and process sample testing
• Developed the antibody, Biotin-conjugated the antibody and optimized several ELISA.
• Produced a series of anti-HIV and anti-HCG monoclonal antibodies, which formed the basis of an ELISA and reagent product line.
• Supervised protein product development team, launched multiple new products including a broad range of proteins and ELISA assay kits;.
• Read ELISA plates by Molecular devices SoftMax Pro (5 parameter logistic analysis) and had introduction to Watson program.
• Develop, optimize, validate and manufacture unique ELISA-based assays for the detection of immune responses in clinical trial patients.
• Developed and optimized ELISA assay to identify the antigen bound by the phage antibody libraries on tumor cell lines.
• Developed cellular IF assays, reporter assays, ELISA assays, ELISPOT assay, and others.
• Developed assay tests, such as ELISA and activity measurements, to fully characterize enzyme matrices.
• Developed and performed troubleshooting for ELISA assays for clinical trial phase II for viral vaccines.
• Developed a highly efficient high-throughput gene delivery system and screening system by ELISA.
• Lead the development program and antibody configuration study for the CT-proET-1 ELISA assay.
• Developed two research ELISA tests for the diagnosis of Alzheimer's disease.
• Skilled in aseptic techniques, ELISA, and cell culture preparation.
• Developed company's first molecular diagnostics platform (multiplex ELISA).
• Screened antibody generation using ELISA, SDS-PAGE, and Western blot.
• Developed test methods for 30-plex ELISA assay validation and quality control.
• Optimized a diagnostic assay (ELISA) for commercial purposes.

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• Collaborated with academic institutions, contract laboratories and manufacturers to establish applicable functionality tests for QC.
• Developed new product QC program significantly reducing costs and delays for experimental vaccine.
• Conducted studies on QC testing and microbiological safety and stability of dietary supplements.
• Directed the QC activity of biochemical characterization of protein molecules.
• Performed QC stability and sterility testing of finished manufactured products.
• Established in house utility-driven QC program and method development.
• Contributed to designing manufacturing and QC procedures.
• Identified and prepared impurity standards for QC
• Responded to customer complaints and helped to resolve QC production problems, made customer calls jointly with marketing and sales representatives.
• Assist the Quality Manager, QC Supervisor, RM Technician, and Microbiologist with various functions as needed or required.
• Investigated and resolved problems in production and QC environments using traditional techniques plus MS, XRF and chemical imaging technologies.
• Coordinated reference standard committee activities between R&D and QC labs to support manufacture and R&D activities.
• Coordinate with QC group, participating EM monitoring activities, such as dynamic EM, static EM, EM PQ.
• Lead trainer for the QC lab-train new hires and other chemists on standard operating procedures as directed by management.
• Arrange picking of new raw materials with scheduling, QC, or vendors, depending on the requested item.
• Work cross-functionally with QS/QC/Production departments, external contractors and suppliers to launch 3 IVD products into the market.
• Collaborate with IARC to provide data, profiles, and QC support for current monographs; and 4.
• Developed statistical approaches to establish QC specifications based on design for six sigma principles (Lean manufacturing).
• Generate work instructions, SOP's, technical report documentation and QC release testing of final products.
• Helped develop and establish a manufacturing/QC process change, reducing costs by ~$20,000 per month.

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• Provide scientific expertise on federal and commercial research projects, including proposal reviews, study execution, and presentations to stakeholders.
• Constructed guidelines and performed research projects to increase knowledge in coordination with the formulation labs establishing a successful international vision.
• Developed and managed scientific research projects related to population health surveillance and determinants of health and health services utilization;.
• Supervised undergraduate intern students, high school summer intern students and visiting international graduate students for their research projects
• Experienced in leading high visibility research projects and assisting management in setting strategic technology direction for the company.
• Directed technical research projects to improve existing architectural ceilings manufacturing processes through laboratory and plant research and development.
• Supervised and conducted numerous research projects into the effects of novel pharmaceuticals on immune system-related functions.
• Articulated and used knowledge of trends in technology and education in collaborative consultations and research projects.
• Initiated and Designed research projects for local educational entities and contributed to development of research methodology.
• Initiated and led internal research projects; Participated in academic competitions; Mentored junior researchers.
• Conducted microbiological research projects involving microbiological characterization and growth patterns of starter cultures and/or contaminants.
• Author reports in feasibility, optimization and formulation development stages of research projects.
• Supervised undergraduate students for summer research projects, mentored and developed junior staff.
• Developed opportunities for undergraduate participation in research projects and training in scientific writing.
• Managed technical research projects and provided consulting services for several government agencies.
• Supervised 4-member project team achieving successful completion of several federal research projects.
• Managed and supervised assistants and students in implementing research projects.
• Identify and contract highly-specialized laboratories to perform outsourced research projects.
• Conceived and developed research projects and supervised their execution.
• Designed multiple research projects; designed and executed experiments.

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• Project Management and Leadership o Communicate effectively and routinely with customer or project stakeholder, project team members, and superiors.
• Project Management Supported NASA funded investigators as an advocate to investigators and to monitor the progress and accomplishments of the investigations.
• Project management, project oversight, subcontractor administration, director of environmental fieldwork activities and drilling sub-contractor oversight.
• Provided project management including technical and budgetary aspects, identified collaborative opportunities, and performed cross-functional duties.
• Provided high-level project management consulting services for development of custom technology solutions for DOD network defenses.
• Familiarized with Project management schedule, Lotus and Statistic software for management skill and data manipulation.
• Managed two independent project management teams aimed at improving the technology and our drug discovery process.
• Developed and managed pharmaceutical application systems, established disaster recovery plans and performed project management.
• Project Management and technical direction of an international feasibility study for the Kingdom of Bahrain.
• Produced cost estimates, provided task-team leadership (project management) on assigned documentation.
• Provided constructive recommendations to project management team for diabetes & oncology drug development.
• Project proposal preparation and project management responsibilities in both government and commercial venues.
• Contributed substantially to CM, Integrated Project Management, and Requirements Management.
• Project management, intellectual property participation, development of worldwide patents.
• Provided technical leadership supporting multiple factory programs, Proposals and Project Management
• Direct responsibility for project management and business development throughout North Carolina.
• Experience developing and implementing project management tools and processes.
• Lead project management initiatives and daily test lab operations.
• Utilized project management in fast-track and innovation projects.
• Completed Learning Tree International Project Management.

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• Assisted in assay development/evaluation of potential small molecule drug targets and in the assessment of potential oncology therapeutics.
• Managed a biochemical assay development and high-throughput screening group reporting to the Senior Director of Discovery Research.
• Provided technical support for diagnostic assay development, database maintenance, data reporting, statistical analysis.
• Assay development, compound screening, identification and optimization for potential drugs of different targets.
• Managed assay development for non-embryonic stem cell culture model to study tissue engineering and regeneration.
• Worked closely with clinical and quality controls departments for assay development and product evaluation.
• Assay development scientist for small molecule antibody synthesis inhibitor project.
• Initiated cancer research and assay development targeting the Hedgehog pathway.
• Established assay development capabilities at Flanders facility.
• Target identification and validation assay development.
• Cell-Based assay development and drug screening: Part of a multidisciplinary scientific team with task to develop and review candidate drugs.
• Acted as a consultant to scientists in different therapeutic areas on issues related to HTS, assay development and laboratory automation.
• Received a Spot Bonus Award for completing assay development and screening of 200,000 compounds within 20 weeks of instrument install.
• Collaborate with a cross functional team for assay development, validation, technique transfer, QC/QA, and manufacture.
• Received Bravo Award for constructing reporter cell lines used in high throughput assay development ahead of schedule.
• Managed target identification, assay development and HTS efforts in Inflammation, COPD, asthma and pain.
• Assay development: Developed proprietary VeraTag assays as part of a panel of cancer diagnostic tests.
• Coordinate with internal departments on cell culture, protein purification, cell sorting and assay development.
• Have extensive experience working with Clinical samples and the CRO's for assay development and validation.
• Spearhead target validation, assay development, lead confirmation and selection, and project development.

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• Conducted screening level risk assessments, for several parcels in preparation for transfer to local community for future commercial/industrial use.
• Achieved this by using various Biological Indicators with range of D-values to assess effectiveness of sterilizing agent and sterilization process
• Conducted exploratory research during free time in PCP-induced social interaction deficits for therapeutic endpoints including schizophrenia and autism.
• Assume leadership role in seeking government and industrial research contract opportunities and develop innovative solutions for proposals.
• Evaluated air quality and/or noise impacts for environmental documents for municipal, industrial, and utility facilities.
• Collaborated with research and clinical development groups, medical directors/investigators and extramural partners in industry or academia.
• Validated mouse diet-induced obesity models and developed computer assisted measurement of drinking and feeding patterns and preferences.
• Attend sales meetings and bid defenses to formally present information on scientific capabilities to pharmaceutical industry clients.
• Reviewed potential market opportunities in clinical decision support and presented findings in corporate strategic planning meetings.
• Collaborate among industry, university and government representatives to increase communication and support project implementation.
• Performed independent technical and quality assurance reviews of data packages completed by other production chemists.
• Provided environmental consulting services for a variety of large industrial clients on many environmental issues.
• Devised systematic process to classify thousands of industrial and commercial codes within a client-specific environment.
• Designed, prepared and screened PDE10a inhibitors for CNS indications using a fluorescence polarization assay.
• Analyzed important solar industry market intelligence in relation to market trends and future product development.
• Fostered productive collaboration and consensus among diverse stakeholders from industry, government and academia.
• Directed and supervised the implementation of horticultural development projects in different states in India.
• Analyzed scientific data and wrote detailed scientific reports and presented findings to high-level managers.
• Recruited and qualified vendors and scientists as external business partners from industry and academia.
• Performed environmental assessments of commercial, industrial, residential, mixed-use and undeveloped properties.

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• Provide process/product development, technical support and improvements to product lines manufactured at ADI operations including design and development plan.
• Served as biological lead and technical support for work directed toward optical standoff detection of biological and chemical agents.
• Determined root cause of several internal and external investigations by consulting for and collaborating with Assay Technical Support group.
• Provided technical support for Bristol-Myers Squibb manufacturing sites and Quality Control management groups to improve manufacturing and laboratory capabilities.
• Provide technical support to the production department during scale up, commissioning/commercialization and normal day-to-day manufacturing activities.
• Directed research and development, technical support and commercial scale-up of new and modified silicone specialty chemicals.
• Provided technical support to all customers; provided all training, process development/improvement and problem solving.
• Developed balancing methods for rotating shafts Provided in-house technical support for special customer troubleshooting and designs.
• Provided scientific and technical support for business decision making in Business Development and Commercial Assessment.
• Provided technical support that identifies process and facility improvements increasing efficiency and productivity 100%.
• Provided technical support and advice in areas of expertise to Engineering Management.
• Provided evaluative and strategic technical support to in-house technology licensing groups.
• Provide technical support and resource information to sample analysis project scientists.
• Provide technical support to manufacturing and packaging areas and investigations.
• Provided technical support on scientific document translation from Chinese.
• Provided technical support for in house reagent manufacturing.
• Provided technical support for problem solving during commercial manufacturing as well as reducing the cycle time using lean and continuous manufacturing.
• Managed R&D responsibility for Gas Plant line with technical support to Oil Field and Refinery product lines.
• Provided technical support to scientific customers of GenVault consumables, hardware and software through both remote and on-site interactions.
• Addressed application/quality issues and provided technical support for Sales, Supply Chain, Operations and Quality Control teams.

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• Researched, designed and implemented the renovation of the IPCT laboratory including designation of capital assets and acquisition of new instrumentation.
• Designed and implemented statistical modeling framework to allow rapid, repeatable, and optimal creation of classification and regression models.
• Author of dozens of publications, including books such as The Strategic Management of Intellectual Capital and Decision-Analytic Intelligent Systems.
• Project manager for implementation of an automated rapid sterility platform to meet the demands of viral and gene therapy manufacturers.
• Resulted in identification of several signaling pathways in neurons that were significantly affected by treatment of potential AD therapies.
• Provided structural elucidation and solid state characterization support for Process development and production of API's and intermediates.
• Established an effective method for visualizing original data vs. purified batch data enabling more rapid pass/fail decisions.
• Developed optimized protocols for the purification of clinical trial material, yielding significant improvements in API purity.
• Communicate with different API manufactures on procuring all the scientific data/reference standards/impurity standards on daily basis.
• Invented methods and reagents for rapid fabrication of synthetic expression chromosomes for facile engineering of microbes.
• Provide technical oversight focusing on developing stability indicating assays for API, intermediates and DP.
• Performed batch testing experiments for establishment of assay/related compounds specifications in API and drug products.
• Developed rapid testing methodology and hardware to facilitate phosphor characterization (optical and electrical).
• Evaluated the application of particle engineering technology in preparation of API material in MDI formulation.
• Reproduced literature to enable rapid start for downstream anticipated target coming out of screening.
• Planned the entire process of bringing in and evaluating different high-throughput capillary sequencing platforms.
• Developed relations with other organizations to identify API's for mutual collaboration.
• Spearheaded two additional Capital laboratory upgrade renovations each costing approximately $3MM.
• Adapted to evolving requirements by employing rapid development and feedback model.
• Managed process chemistry projects for API scale-up deliveries in early development.

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• Devised and implemented high throughput method for generation of protein fusions and successfully generated active protein fusions of hydrocarbon producing enzymes.
• Researched new algorithms and built large-scale application systems for high throughput biological combination assay data storage, management and analysis.
• Researched advanced and robust computational algorithms for high throughput analysis and modeling of quantitative high throughput screening data.
• Developed and transferred cell-based and biochemical assays to cross-matrix teams for high throughput screening to enable lead identification.
• Investigated diverse methods of protein expression, purification, conjugation, characterization and high throughput screening.
• Developed software algorithms for collection, organization, and high throughput analysis for validation testing.
• Have implemented and utilized high throughput purification approaches to target molecule discovery.
• Nominated 14+ obesity/diabetes/CNS targets for high throughput screening initiation.
• Developed and implemented high throughput cell-based transporter assays.
• Developed and validated high throughput screening assays.
• Develop high throughput formulation screening.
• Implemented diverse assays using reporter-gene, FP, HTRF, fluorescence, and luminescence to create effective high throughput screening assays.
• Worked in both raw material and final test clinical chemistry test laboratories supporting high throughput while ensuring compliance to ISO/QSR regulations.
• Specialized in develop cell-based assays by using frozen cells (Assay Ready Cell, ARC) for high throughput settings.
• Improved laboratory operations by introducing efficient and cost effective high throughput technologies that reduced sample processing time by 50%.
• Perform daily operation of LC/MS system for affinity based high throughput screening (small molecule) and project follow-ups.
• Developed high throughput screens to identify chemicals that confer drought/heat tolerance using crop and non-crop model systems.
• Developed and implemented high throughput assay for compound candidates screening (2D and 3D spheroids).
• Identified compounds that inhibit Human Immunodeficiency Virus (HIV) by High Throughput FACS based Screening.
• Developed various software and utilities for Oracle databases for High Throughput Screening and Chemistry Information Databases.

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• Research included optimization of emulsion PCR, sequencing by ligation, and development of novel mate-paired library construction methods.
• Collaborated with automation engineers to automate creation of sequencing templates and to automate emulsion PCR reaction setup.
• Designed and synthesized novel small molecule antagonists for two GPCR receptor programs for oncology and inflammation.
• PCR-based assay development for the detection of lung cancer somatic mutations using tumor circulating nucleic acids
• Manage / conduct laboratory investigations both PCR and engineering based.
• Led formulation development for emulsion PCR with improved emulsion stability.
• Investigated nucleic acid-extraction methods for sample preparation before PCR.
• Optimize PCR amplification and detection conditions.
• Developed and validated PCR-based diagnostic assays.
• Assisted Marketing team in developing training materials on basic principles of real time PCR for sales force Advancements in Real-Time PCR.
• Prepared HIV RNA, RT-PCR and purified PCR products for sequencing and analyzed approximately 500k bases sequence so far; 5.
• Conducted QC product release, stability testing, results analysis, and data management for all marketed PCR diagnostic products.
• Led a team of medicinal chemists in optimizing a T2R67 GPCR bitter blocker lead which was moved into product development.
• Conducted PCR analysis in the confirmation of the transgenic protein gene sequence present in the seed used for the study.
• Supervised R & D function on various other projects, utilizing GC, HPLC, PCR and other techniques.
• Identified endogenous expression of gene, receptor, catalytic enzyme in cell lines with Q-PCR and transcription reporter assay.
• Worked at the bench, performing hit to lead optimization of HTS identified compounds for several GPCR taste receptors.
• Conducted molecular biology (DNA sequencing, DNA/RNA purification, transformation, PCR, cloning, restriction digestion).
• Project 1: One step Sample Prep linked to the highly multiplexed TaqMan PCR assay on the surface.
• Developed and validated Real-time PCR-based assay for quality control (%X-bearing sperm) of a new product.

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• Coordinated the optimization, qualification, and clinical sample testing of coagulation factor assays in a regulated laboratory under GCP.
• Tested safety and efficacy of prototype research and reference vaccine formulations in GCP clinical studies.c.
• Performed GC analysis in support of spontaneous combustion resolution.
• Conducted animal experiments and prepared GC/MS samples for analysis.
• Concentrate on GC method development and validation/ verification.
• Developed and validated in-house test methods for GC and GC-MS analysis, later adopted into law as Health Canada official methods.
• Introduced use of generic GC methods for residual solvent analyses, streamlining process and driving method validation efforts for multiple projects.
• Discovered a novel ER-stress responsive sugar-6-phosphate on FACE gel, GC-MS and LC-MS analysis suggested it was a 5-carbon sugar phosphate.
• Solved a rarely-occurred problem related to the matrix effect in the GC determination of one reagent in one drug substance.
• Developed, optimized and validated methods for materials analysis using TGA, GC, IC, FTIR, GC/FTIR/MS.
• Led development of new Solid Phase MicroExtraction (SPME) GC-MS methods for analysis of small molecule fermentation byproducts.
• Validated methods for testing monomers and polymers (GC, HPLC, AA) so lenses could be produced.
• Utilized technical and creative skills during brain storming sessions for the Productivity team and the Global chocolate GCT.
• Facilitate sample follow-up through supplemental analyses (GC, NMR) and lead remediation efforts for incorrect submissions.
• Designed, developed and implemented CGI interface to a LIMS for supporting the HAGC sequencing facility.
• Provided training on GC testing and instrumentation issues on a routine basis to the QA Lab.
• Optimized the method on two GC columns using an FID detector and Pulsed Ionization detector.
• Identified and quantified impurities utilizing HPLC, IC, FT-IR, GC-MS and GC.
• Analyzed data from GCOD with R (for statistics) and application specific software.
• Performed unknown impurity investigation and structural elucidation using LC-HRMS, GC-MS and MS/MS techniques.

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• Produced scientific and technical reports for the Legal Department in relation to alleged patent infringement and consumer product liability cases.
• Prepared the technical reports presented to the ITU demonstrating compliance with international interference requirements for satellite slot filings.
• Developed and conducted installation, operation and performance qualifications, process validation and prepared technical reports.
• Generate technical reports and present to peer engineers and management as well as external consumer electronics customers
• Prepared and presented detailed technical reports to senior management for experimental results and laboratory investigations.
• Established rigorous statistical analysis for method development and qualification, reviewing data for technical reports.
• Prepare development proposals, execute protocols, and generate technical reports and regulatory submission documents.
• Prepared research reports, technical reports and summaries for technical presentations and regulatory submissions.
• Identify process deviations, prepare technical reports and propose comprehensive process solutions and improvements.
• Authored technical reports and provided rationale for future work and recommendation.
• Edited and published intellectual property, technical reports & marketing literature.
• Write detailed technical reports and presentations for government customers.
• Provided technical reports and presentations to diverse audiences.
• Authored technical reports including method validation summary reports.
• Prepared/reviewed technical reports, protocols, specifications.
• Author technical reports ready for regulatory submissions.
• Conducted scientific/literature reviews, prepared technical reports.
• Prepare technical reports to document field investigations.
• Prepared research proposals and technical reports.
• Prepared technical reports for internal distribution.

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• Developed, optimized and validated LCMS methods for analyzing proteins and antibodies in support of target identification, validation and pharmacology.
• Evaluated 2.5 million biological screening results using clustering algorithms, predictive models, cross-validation, calculated properties, and biophysical methods.
• Interacted closely with material suppliers to establish specification-properties relationships to optimize the latex foam integrity and subsequent vulcanization process improvements.
• Supported development of a continuous subcutaneous insulin infusion device by performing analysis of commercial insulin dose formulations by HPLC.
• Experience in protein isolation, protein purification, protein conjugation with biotin and characterization of protein conjugates using LC/MS.
• Negotiated pricing structure for LC/MS instrumentation directly with manufacturers at a corporate level.
• Developed simulated drug release testing and developed HPLC test methods for analysis.
• Perform LC-MS system maintenance/troubleshooting and assist technicians on related service requests.
• Develop high throughput metabolite analyses using high resolution LC-MS methodologies.
• Designed and executed HPLC method qualification/validation; drafted qualification/validation report.
• Develop drug product assay/impurities HPLC methods and dissolution methods.
• Developed HPLC purification and library technology skills.
• Perform HPLC validations and reference standard certifications.
• Supervised installations and maintenance of LC/MS instrumentation.
• Performed protein characterization by RP-HPLC.
• Conduct impurities identification via LC/MS.
• Evaluated and established imaging of cytoplasmic calcium changes as a marker to determine the presence of functional receptors in pancreatic islets.
• Led efforts to develop infrastructure and streamlined in-house mass mapping process for sample preparation, LC-MS analysis, and data processing.
• Cost calculations involving raising starter plants, greenhouse planting, wholesale marketing to the growers and profitability estimates were done.
• Maintain, calibrate, and perform trouble-shooting for HPLC and MS instruments in order to maximize instrument efficiency and performance.

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• Ensured facility technical readiness activities complete to appropriate local and federal regulatory standards before commencing full operation within the new laboratory.
• Collaborated on drug product characterization studies for various products and successfully submitted three NDA submissions which have received approvals.
• Contributed to development of manufacturing procedures and training of manufacturing team on the Precision Plus Protein Standards project.
• Monitored new products when introduced to ensure quality and manufacturing standards continue to meet specifications and performance requirements.
• Synthesized paraffin inhibitors; production evaluation, performance testing, formulation, recommendation, oilfield technology support.
• Addressed quality issues including determination of root causes and recommendation of manufacturing changes for manufacturing defect returns.
• Provided recommendations and technical directions to associate scientists to conduct experiments, interpret data and generate reports.
• Designed and developed an algorithm for boundary detection and tracking in medical images using Finite Element Modeling.
• Developed Sensory test methods, recommendations and approval to define fragrance combination used in scenting device.
• Provided technical and operational recommendations in meeting safety, quality, productivity and on- time delivery.
• Developed novel assays/reagents for high throughput screening, and functional secondary assays for compound evaluation.
• Led and participated in multiple global teams to standardize/harmonize multiple development processes within the company.
• Key member of team that analyzed and presented data on quality improvement and formulated recommendations.
• Designed and performed failure analysis to understand the fundamentals and help develop better materials.
• Helped to set requirements for Laboratory Investigations to meet current regulatory and company standards.
• Manage & train personnel including performance appraisals, salary recommendations, and disciplinary action.
• Implemented fundamental shift in work culture of innovations group from research to research-for-commercialization.
• Created standardized technical documentation templates which were adopted for a critical government contract.
• Designed and created assay forms and developed paperless systems to simplify/standardize/train complex assays.
• Analyzed experimental data for candidate compounds and made recommendations regarding further development.

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• Managed inventory of raw materials and newly manufactured products using SAP management system with minimal discrepancies, decreasing inventory costs.
• Supported and executed implementation of new and modified manufacturing processes, raw materials, and process improvements.
• Created and/or revised specifications for raw materials and all finished products related to these categories.
• Work on reformulation and alternate raw materials to find productivity opportunities.
• Performed identification testing of raw materials using Fourier Transform Infrared Spectroscopy.
• Developed procedures for the characterization of raw materials from vendors.
• Salvaged raw materials, conformed finished products and analyzed data.
• Performed vendor qualifications on raw materials for new formulations.
• Analyze properties of water based, reactive, and hot melt adhesives, sealants, finished products, and raw materials.
• Work lead to the reduced cost (in excess of 50%) of raw materials and decreased used of halogens.
• Provided specifications for raw materials and finished product offerings for products responsible for over 130 million dollars of company revenue.
• Implemented Raw Material Tracking program to ensure key raw materials and consumable product inventories are maintained above safety stock levels.
• Conducted testing of raw materials, and in-process samples, and all final products to ensure microorganisms are within specifications.
• Performed difficult and advanced analysis of various raw materials, finished products, validation, stability, and method transfer.
• Support development, formulations, engineering and marketing activities by evaluating the performance of raw materials and products.
• Developed, validated and transferred new methods for the analysis of finished drug substances and raw materials.
• Searched and evaluated different raw materials that would perform equally or better than the original material.
• Manage >40000 catalog products, ~10000 raw materials, ~5000 notebook pages, 4000 projects,
• Developed more robust calibrations for NIR library and quantitative methods for raw materials, improving quality.
• Retain raw materials, bulk, and finished product samples, and manage retain disposal.

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• Conducted statistical design of experiments (DOE) and statistical analysis of experimental data.
• Designed and supervised experiments utilizing a variety of experimental approaches (DOE).
• Utilized statistical analysis methodology (DOE) in process validation studies.
• Developed purification method for bacterial inclusion body proteins using DoE.
• Used DoE approach to identify critical process parameters.
• Used Design of Experiments (DOE) software for synthetic process development and for determination of critical and optimal process parameters.
• Applied DOE in the formulation and process development for immediate release and modified release solid dosage forms for multiple projects.
• Authored Affirmative Procurement Proposal draft cited for excellence by DOE and distributed to other DOE sites as model plan.
• Use of Design of Experiments (DoE) for Process R&D robustness and optimization using Design Expert.
• Applied DoE and QbD to the process development to identify critical manufacturing parameters for a late-stage drug candidate.
• Design, formulating and conducting Design of Experiments (DOE) for the patented reagents for phosphate industry.
• Utilized DOE to develop optimal process parameters from bench to pilot sale production with in 30 days.
• Introduced DOE as a key technique to enable learning, marrying both instrumental and sensory techniques.
• Completed required company training in Advanced HACCP, DOE, Supplier Quality, Patents, etc.
• Frequent use of statistical design (DoE) to solve chemical problems and establish process ranges.
• Research proposal writing and project management for DoD, DoE, NASA and other agencies.
• Review research proposals on high-energy physics for the US Department of Energy (DOE).
• Lead and conducted DOE studies for specific methods transiting from early phase to late phase.
• Served as Crisis Response Scientist for the DOE NRAT/RAP0 and AMS emergency response teams.
• Guide research direction, monitor budgets and fulfill contractual obligations to the US DOE.

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• Provided technical contributions, operations leadership and knowledge of drug discovery to deliver novel drug candidates for clinical development.
• Designed and synthesized drug candidates based around SAR with the assistance of computational modeling and X-ray crystallography.
• Participated in synthetic discovery and scale-up of antiviral and anticancer drug candidates in the Pharmaceuticals Division.
• Identified wound healing drug candidates and managed collaborative research with academic and contract labs.
• Conducted research and development of potential Cardiovascular and Metabolic drug candidates and related intermediates.
• Helped company evaluate potential new drug candidates for company s pipeline development.
• Prepared documentation as required to support regulatory filings for drug candidates.
• Worked with pharmaceutical company to develop newly identified drug candidates.
• Supported IND and NDA filings by writing up detailed descriptions and results of physical properties assays for drug candidates of interest.
• Performed process research and development for new target molecules; expeditiously developed and scaled up new processes for drug candidates.
• Experience in lead optimization of anti-viral (Hepatitis-c) drug candidates, antibacterial agents and KV-7 channel activators.
• Led all predictive model and new methodology development that was used to select drug candidates for clinical evaluation.
• Led the identification and strategic design of new drug candidates for clients and company's proprietary portfolios.
• Synthesized fifty new drug candidates in one year, with an average of five steps per synthesis.
• Use machine learning algorithm and virtual chemical library to model molecular interactions and find new drug candidates.
• Developed multiple LC-MS/MS assays for many drug candidates dosed simultaneously via an N-in one cassette dose.
• Worked with CRO's for purification of larger scale batches of drug candidates and for SAR.
• Implemented small satellite teams to resolve urgent issues that threatened the development process of drug candidates.
• Led and participated in the process development and scale-up efforts on drug candidates.
• Led project team who searched for drug candidates to treat glaucoma.

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• Participated in various cross functional project teams to provide CMC expertise in regulatory strategy and post approval submissions.
• Supervised high-caliber projects that optimized product and process development while addressing/satisfying key regulatory questions around CMC.
• Compiled CMC information and reported it to the Formulation Director and Senior Vice-President.
• Developed global regulatory filing strategy for post approval CMC changes.
• Co-author and review CMC related regulatory correspondence and submissions.
• Prepared CMC documents involved with formulation and process development.
• Authored CMC sections of approved regulatory submissions.
• Documented and reviewed the CMC section of clinical study reports, labeling drafts, validation and stability protocols and reports.
• Authored the drug product CMC section of the IND and NDA/MAA filings that were successfully accepted by the regulatory authorities.
• Participated in IND and NDA (CMC section) filings, and day-to-day management of out-sourced API contract manufacturing.
• Served as the CMC team leader for a feasibility project delivering a protein via the inhalation route of administration.
• Conducted dissolution and stability studies, wrote reports and prepared CMC documents to support submissions to regulatory agencies.
• Contributed to and reviewed CMC sections included in IND submission, IND amendments, and annual reports.
• Assisted in the preparation of IND amendments and selected documents for the CMC section of a BLA.
• Prepared documents for the CMC section of new animal drug applications during development and for market approval.
• Managed complex CMC aspects of assigned applications to navigate successfully through the process to resolution of AIP.
• Assisted our customer to prepare the document for CMC section of IND and NDA drug submission.
• Participate in writing and reviewing the documents for CTD module 3- CMC sections for diverse products.
• Prepared and wrote the CMC (chemistry, manufacturing and controls) portion for IND/NDA submissions.
• Worked with customer to satisfy FDA deficiency responses to the CMC section of their filing.

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• Authored method development plans, validation protocols, in order to establish test procedures to perform quantitative color measurements.
• Complied various verification and design validation protocols, in-process comparability studies, project improvement and characterization reports.
• Prepared and reviewed documentations including specification, validation protocols and reports.
• Prepared and executed validation protocols for instrument/computer interfaces.
• Reviewed method validation protocols and product specification justifications.
• Develop sterilization validation protocols for client-sponsored programs.
• Executed validation protocols for process and equipment.
• Authored validation protocols and technical reports.
• Led development of validation protocols and methods for test procedures, driving successful product release tests and raw material acceptance.
• Design, review and prepare validation protocols, method transfer protocols, project status reports and method validation reports.
• Tasked with preparing and reviewing test methods, validation protocols, validation reports, and method development reports.
• Documented design specifications, design change plans, CAPA, verification and validation protocols and reports.
• Process Improvements- Assist in the execution of validation protocols to support the implementation of LABWARE LIMS.
• Author method validation protocols, reports, test procedures, technical documents & method transfers.
• Write methods, validation protocols and reports as per the client requirements and regulatory guidelines.
• Drafted risk assessments, validation protocols, summary reports and validation test procedures.
• Write and design the validation protocols for new products.
• Write and review method validation protocols and reports.
• Developed Methods, and wrote validation protocols.
• Developed analytical methods, designed method validation protocols, performed all the necessary experiments, and wrote study reports.

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• Discovered the ability of technology to enhance antiseptics and secured Phase I SBIR grant for the development of this application.
• Secured a $100K Phase I small business innovation research (SBIR) grant from USDA to support this research.
• Helped establish tissue engineered intestine research from scratch and awarded from Ohio State Third Frontier and SBIR Phase I.
• Joined company as first FTE and established ImaginAb's laboratory facility - Co-authored successful application for NCI SBIR funding.
• Based on the successes from SBIR projects NanoScale recently received $30MM decontamination product acquisition contract from DoD ARO.
• Project manager of a DoD Phase 2 SBIR that developed the first rad-hard by design infrared band-pass filters.
• Major achievements: Project Leader in 2 awarded NIH-SBIR grants (Phase I and II).
• Project manager on the NIH SBIR grant # 1R43DK085754-01 entitled -Outpatient treatment for portal hypertension-.
• Assist with preparation and submission of SBIR/STTR proposals that received funding for product development.
• Served as PI in DOD SBIR project AF 112-017 Curved Sensor for Vision Systems.
• Apply proposed technology for funding (SBIR program, Federal and State sources).
• Authored National Cancer Institute SBIR Phase I applications research plan for cancer treatment development.
• Developed strong scientific rationale and technical plan for new NIH SBIR grant application.
• Involved in generating and supporting new SBIR grants to develop small molecule therapeutics.
• Conduct laboratory research and product development for private industry or SBIR projects.
• Phase I MDA SBIR for the conceptual development of Mobile Ground Systems.
• Have provided preliminary data to support the application of SBIR Phase II.
• Received funding for two SBIR grants involving design and commercialization of assays.
• Prepared and submitted Small Business Innovation Research (SBIR) proposals.
• Secured a SBIR Phase I grant based on the screen results.

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• Directed and guided analysts in resolving instrumentation problems and provided support to QA in updating Quality Standard procedures as needed.
• Reported laboratory and supplier investigations related metrics and trends on a monthly basis to the QA and Laboratory management.
• Improved cell labeling procedure amenable to manufacturing and supported QA audit for potential manufacturing site.
• Conducted investigations on existing products and provided technical assistance to QA and manufacturing functions.
• Assisted QA department in updating and editing controlled documents related to processes and instrumentation.
• Reviewed batch records and associated documents for accuracy before submitting to QA inspection.
• Performed clinical laboratory assays and QC/QA for the Genetics and Immunology departments.
• Facilitated and participated in both internal and external QA audits.
• Team member for standardizing calibration procedures throughout all QA laboratories.
• Collaborated with QA, established manufacturing operator training program.
• Conduct fire behavior predictions, spatial modeling, GIS tool development, database management, QA / QC and technology transfer.
• Coordinated project team meetings consisting of Client, Project manager, supervisors from cell culture, Production, QC and QA.
• Interact with QA and QC Departments to complete quality and OOS investigations and develop the appropriate corrective and preventative action plans.
• Selected Highlights: * Contributed to significant improvements & discoveries to trouble-shoot QA testing of diagnostic kit reagents & procedure designs.
• Conduct the Laboratory Deviations and Laboratory Deviations for Raw materials, In Process and Finished Product analyzed in the QA Laboratory.
• Conducted the Critical Quality Attribute (CQA) assessment of aIL13, including fraction collection and characterization of the minor variants.
• Collaborated with QA and Packaging inspection to establish a quarterly audit of particles observed in vaccines to monitor particles in vaccines.
• Authored the QA release SOP utilized by Pfizer Michigan Pharmaceutical Science for the review and disposition of packaging batch records.
• Managed method and SOP developments, as well as maintenance of QC and QA data, using SAP system.
• Coordinated with cross-functional team to be compliant with the appropriate standard required for Safety, QC and QA.

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• Developed novel mass-based, high throughput biochemical assay to support artifact-free identification of inhibitors and guided SAR progression of compounds.
• Maintained laboratory inventory, ordered laboratory supplies, calibrated laboratory equipment, and handled customer care issues as necessary.
• Documented the methods developed and supervised daily operations of the lab while maintaining necessary supplies for daily operations.
• Participated in vendor-related project activities as necessary, including tech transfer activities, trouble-shooting and on-site visits.
• Complete all necessary training programs and implement to help the company maintain regulatory compliance with regulatory bodies.
• Completed equipment and data investigations when necessary to ensure the accuracy and dependability of the data produced.
• Identified and purchased the instrumentation necessary to equip a fully functional laboratory for Nasal Spray characterization.
• Established minimum trace metal requirements necessary for cells to maintain high productivity of acetic acid formation.
• Developed and implemented various DMPK/drug safety screening cascades enabling identification of scaffold liabilities and SAR optimization.
• Model optical degradation and other instrument anomalies and obtain necessary corrections to the scientific data.
• Investigated consumer complaints relating to microbiological quality, and represented Kraft during litigation when necessary.
• Coordinated document review with Veterans Affairs staff and local government agencies to obtain necessary approvals.
• Developed and performed appropriate staining methodologies on FFPE slides as necessary for different protocols.
• Developed techniques deemed necessary to succeed and lead in a team-oriented environment.
• Develop, validate and modify assays as necessary in conjunction with supervisor.
• Developed and validated ELISA assays necessary for providing information for PK/PD analysis.
• Lead and conduct necessary experimentation to support client legal projects.
• Pinpointed necessary improvements to manufacturing processes for high quality products.
• Produced analogues for SAR studies that exceeded external customer specifications.
• Designed and implemented validation studies as necessary for product transfer.

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• Managed an NMR spectroscopy laboratory with two NMR instruments, including calibration, maintenance, troubleshooting, and training users.
• Accomplished the synthesis of linear and branched Lariat RNA, and studied their conformation by 500 MHz NMR spectroscopy.
• Served as NMR and MS Subject Matter Expert, and Lead person for stability and compatibility projects.
• Characterized the synthesized compounds using UPLC, NMR, FT-IR, Mass Spectroscopy and Elemental Analysis.
• Gain extensive experiences in NMR and X-ray structure aided FBDD, and structure based drug design.
• Characterized final products and intermediates using 1H, 13C, 2-D NMR and MSLC.
• Develop LC-NMR and LC-MS methodologies for the identification of impurities present in drug products.
• Maintain the NMR instruments and automation system and control budget for the NMR instrument.
• Increase the capability of the NMR lab, by adding new experiments and methodologies.
• Design novel NMR pulse sequences to improve sensitivity and reduce time and cost.
• Apply and recommend NMR and other biophysical tools to support FBLG campaigns.
• Designed a system for on-the-fly structural verification by NMR of compounds.
• Evaluate hits from high-throughput screening and high-concentration screening by NMR technology.
• Assisted on the isolation of metabolites via prep-LC for NMR analysis.
• Started up a state-of-the-art NMR laboratory in R&D.
• Identified lower level impurities without isolation by LC/MS/NMR.
• Train colleagues on NMR & Mass Spectral techniques.
• Upgraded spectrometers and developed new NMR techniques.
• Utilized LCNMR for analysis of reaction mixtures.
• Operated solid-state NMR probes with zirconium rotors.

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• Communicate frequently with individuals within chemistry, inflammation biology, PK/PD and formulations groups to deliver next-round compounds with improved properties.
• Implemented a quality control program for preliminary and final products including microbiology, viscosity and color stabilization for the products.
• Managed a BSL-2 laboratory at EnviroLogix Inc. involving training and supervision of a laboratory assistant with Microbiology related laboratory procedures.
• Negotiated and managed contractual arrangements with hardware and software vendors for Information Technology, Chemistry, Biology and Clinical Departments.
• Designed and performed molecular and cell biology experiments to investigate insulin signaling, insulin resistance, and carbon flux.
• Led 4 scientists in Microbiology and Biochemistry Groups - Designed and established new state-of-the-art microbiology and biochemistry laboratories.
• Experience in working in a cross-functional teams integrating engineering, biochemistry and molecular biology experience for hardware development.
• Researched sexually transmitted diseases, particularly Syphilis and other genital ulcer diseases using molecular biology and microbiology techniques.
• Investigated the biology and relevance of potential antibody targets in human cancers by coordinating several team efforts.
• Managed Immunology and Cell Biology research programs and contract research services, including project and personnel management.
• Utilized cell culture and molecular biology experience to develop and troubleshoot cell based assays for drug discovery.
• Broadened studies for improving host strains containing antibiotics pathways using various molecular and cell biology technologies.
• Provide internal technical support for Product Development * Provide internal technical support for the Microbiology Department.
• Authored reports on assay development, molecular biology and laboratory protocols and drug target discovery.
• Designed and performed cellular biochemical assays to elucidate kinetics of hits on targeted biology pathways.
• Acted as team-leader for site-wide daily microbiology monitoring programs and team-representative for site-wide process validations.
• Established molecular biology laboratory, conceived and directed research projects in molecular biology.
• Established a new Molecular Biology Laboratory from scratch and a limited budget.
• Participated on several project management committees as the group cell biology representative.
• Supervised and trained intern/team members in surgery, pathology and molecular biology.

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• Founder and Project Manager of an international consortium to adapt the technology for robotic inspection of subterranean natural gas pipes.
• Presented relevant scientific material at national and international meetings such as American Chemical Society and Cambridge Health Institute BioIT etc.
• Performed performance evaluation of external sample preparation technologies performance to verify its feasibility and alignment with company technology.
• Directed day-to-day research project activities and acted as an internal resource for technical information pertaining to biological science.
• Write original papers for the publication in peer-reviewed scientific journal; Present research results at international scientific conferences.
• Managed research activities of several external collaborators for an additional late stage innate immunity target for pulmonary disease.
• Represented the company in international conferences, business meetings and published 2 international research papers as corresponding author.
• Collaborated with internal regulatory group and external suppliers to identify technologies and ingredients to meet USDA claim requirements.
• Managed external testing laboratories to perform safety and efficacy evaluations to support product claims of new products.
• Deployed the compound registration solution thereby increasing corporate data integrity and enabling data exchange with external collaborators.
• Provided support to customers and acted as internal technical representative during the development of scientific mobile applications.
• Collaborated with legal, marketing, external relations, and product development professionals to generate business values.
• Investigated alternate series; designed and synthesized analogs to establish a relationship between potency and metabolic stability.
• Project involved root cause failure analysis, developing alternatives, qualification and scale up to commercialization.
• Team successfully identified an internally developed tau antibody that passed criteria for progression to clinical development.
• Performed routine laboratory internal audits, initiated deficiencies reports, and followed up for corrective actions.
• Stayed current with new scientific knowledge through literature searches, participating internal seminars and external conferences.
• Authored 24 peer-reviewed scientific publications, co-inventor on 25 patents, and presented nine international seminars.
• Organized external collaboration and beta-testing of new reagents, leading to several peer review publications.
• Advanced external partnerships that enabled filling the innovation pipeline and identified brand maintenance opportunities.

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• Organize raw data within Analyst and prepare reports utilizing Watson PK/PD modeling software as well as in-house software for report generation.
• Conducted large scale PK/PD studies involving freehand ICV injection in mice & IT catheter placement & dosing in rats.
• Integrate PK/PD design, PK modeling and molecule attributes for formulation development and trouble shooting for any delivery issues.
• Planned, implemented, interpreted and reported assigned Phase I to Phase III PK and PK/PD studies.
• Established 23 PK assays which defined PK/PD relationships and allowed human dose prediction for an IND submission.
• Design and analyzed PK data with WinNonLin, and performed PK/PD modeling (as needed).
• Afforded research team the opportunity to be on schedule for PK/PD and toxicology studies.
• Improved efficiency in rodent PK/PD studies by utilizing the CULEX automated blood collection system.
• Reviewed PK/PD data, recommended future studies to advance lead candidates.
• Developed ELISA-based assays for PK/PD studies, product testing.
• Coordinated and conducted PK/PD testing for multiple projects.
• Managed PK experiments focused on oral bioavailability, PK/PD relationships and experimental lipid-based formulations for improved drug delivery.
• Authored pre-clinical reports summarizing the PK/PD evaluation of several development compounds.
• Conducted population PK modeling, covariate and exploratory PK/PD analyses.
• Performed population pharmacokinetic and PK/PD modeling.
• Developed inhalation, oral, and parenteral formulations, which enabled PK/PD, Toxicity, and/or FIH studies.
• Established and validated a variety of in vivo disease models to perform PK/PD studies to evaluate compounds efficacy.
• Designed & finished 10+ PK/PD/Tox CRO studies in support of 3 drug-development projects as Study Monitor.
• Demonstrated differential PK/PD correlations of native and pegylated growth hormone in the knee joint.
• Oversee PK/PD, efficacy, model development, biomarker identification, and drug combinations.

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• Applied scientific principles in designing, conducting, and analyzing data with product investigations, full-scale process characterizations and validation activities.
• Managed relationships with customer companies and delivered information and proposals after executing on-site development studies with customers' products.
• Conducted on-site construction and restoration oversight and inspection on numerous natural gas pipeline projects for government and third-party clients.
• Provided guidance and proposed bridging studies to clients in anticipation of regulatory requirements that led to successful approvals.
• Played pivotal role in cross-disciplinary study for developing novel method in validating imaging results using finite element analysis.
• Managed control account within Earned Value Management project planning environment, and participated in Department of Defense audit.
• Assisted multiple DoD agencies by providing expert technical evaluation and review of proposed research and development projects.
• Provided consultation to municipalities with regard to the purchase of properties for conservation or wildlife habitat protection.
• Directed two associate scientists to ensure timely delivery of study results for decision making and pipeline advancement.
• Developed key relationships utilizing a collaborative style, including team building, executive interactions and staff engagement.
• Staffed, equipped and managed a new BSL2+ laboratory for production and characterization of live-virus vaccine candidates.
• Provided technical leadership and scientific expertise to lead and/or coordinate product/process validation, improvement and troubleshooting.
• Provided technical leadership ensuring investigator initiated research grant agreement responsibilities in Women's Health were met.
• Communicate, coordinate and negotiate with stakeholders at multiple levels of both management and technical expertise.
• Represented company in research consortium for building a pipeline of new value-added products.
• Led personal cleansing formula development, producing multiple lead candidates for consumer testing.
• Served on Quality Assurance team responsible for laboratory equipment management and internal audits.
• Initiated and successfully developed multiple company propitiatory molecular diagnostic tests for multiple diseases.
• Used opportunity to strengthen understanding of production requirements and knowledge of equipment operations.
• Studied climate variability and relations between tropical precipitation and sea surface temperature.

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• Directed collaborative studies with several investigators at the NIH and other institutions.
• Participated as co-investigator or key personnel in several NIH grant applications.
• Secured NIH funding, pharmaceutical contracts, and deep pocket community leader support, leveraging close ties to the community.
• Drafted grant proposals, and acted as a principal Investigator (PI) of an over two-million NIH sponsored project.
• Assembled technical data summaries for the submission of progress reports to government funding agencies such as the NIH and NIJ.
• Review and comment on business strategies with large and small corporate partnerships and strategic alliances and NIH grants.
• Completed research project specified in the PI's NIH grant, and advanced it to a new level.
• Worked directly with clients at NIH, Universities, and large and small pharmaceutical companies.
• Awarded; National Center for Complementary and Integrative Health Grant (NCCIH/NCCAM), NIH.
• Helped in grant writing with one of the grants awarded an NIH Phase 1 funding.
• Provided contract services to pharmaceutical, government labs such as the NIH and NCI.
• Awarded in 2009 under the NIH Challenge Grants in Health and Science Research initiative.
• Served as liaison for outside collaborations and as a co-PI for several NIH grants.
• Excelled in preparing manuscripts for peer-reviewed journals, and crafting NIH grant proposals.
• Headed the development of federal grant for funding from NIH.
• Research support: NIH RO1 and American Heart Association.
• Participated in submission of 18 NIH grants.
• Co-authored 7 funded awards (4 NIH grants, 1 DOD contract, and 2 State of Maryland awards).
• Developed innovative optoelectronic and optical fiber devices for DoD and NIH projects.
• Participated in NIH training for laboratory techniques used in biosimilars.

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• Optimized protein digestion procedure and performed subsequent mass spectrometry analysis as part of team developing protein-protein interaction strategy.
• Initiated, developed and coordinated consulting relationships with leading academic researchers in mass spectrometry.
• Worked with innovative tagging chemistry for quantitative mass spectrometry applications.
• Project manager and lead scientist for the commercial development of a surface acoustic wave ion source for mass spectrometry.
• Developed, validated, and conducted affinity selection mass spectrometry (ASMS) technology for high throughput drug screening.
• Developed UPLC SEC methods for Affinity Selection Mass Spectrometry (ASMS), analyzed protein aggregation under ASMS conditions.
• Serve as internationally recognized expert in the field of Secondary Ion Mass Spectrometry (SIMS).
• Characterized compounds by mass spectrometry, IR, NMR and submitted compounds for elemental analysis.
• Supervised and mentored 1 employee in analysis of protein drug candidates via mass spectrometry.
• Trace metals analysis of samples using inductively coupled plasma-mass spectrometry (ICP-MS).
• Involved in the use of atmospheric pressure ionization mass spectrometry (APIMS).
• Developed a new method of magnetic field measurement for process mass spectrometry.
• Received Technical Advisory Board Award for Mass Spectrometry (2003).
• Managed growth and development of the Mass Spectrometry Group.
• Developed electrospray ionization Fourier transform ion cyclotron resonance mass spectrometry based assays for high throughput drug screening against RNA targets.
• Launch a new & aggressive Mass Spectrometry program to enhance radiochemical synthetic capabilities.
• Completed several projects using tandem Mass Spectrometry to quantitate proteins in biological systems.
• Key in the recruitment of essential Proteomics personnel including group head, 2D gel head, and additional mass spectrometry personnel.
• Developed the mass spectrometry analytical approach for supporting the High Through Put screening ADME project for compound candidates.
• Project leader of R and D and analysis of pharmaceutical drugs using gas and Liquid chromatography mass spectrometry

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• Managed a group of Research Associates supporting protein purification research and development.
• Supervised research associates processing development samples and other development activities.
• Provided day-to-day supervision for Scientists, Research Associates and Laboratory Interns
• Experience in supervising scientists and research associates for project execution.
• Directed and supervised lower level scientists and research associates.
• Supervised multiple senior research associates and vivarium staff.
• Supervised three research associates and several temporary personnel.
• Supervised/educated research associates in all assay platforms.
• Direct research associates in their laboratory duties
• Supervised and managed 3 Scientist/Research Associates.
• Mentored and supervised research associates.
• Coordinated the efforts of Research Associates from initial procurement of materials to final QA approval and product release.
• Trained more than 20 research associates, and assumed project leadership for number of projects as needed.
• Plan and supervise research associates, practical synthetic schemes, scale up and optimization of current process.
• Trained more than 15 research associates, and provided leadership for number of projects.
• Lead a group of scientists and research associates to perform real human antibody generation.
• Hired, trained and evaluated the performance of Research Assistants and Research Associates.
• Supervised a team of 12 associate scientists and research associates in producing approx.
• Supervised research associates, reviewed performance, and assisted in career development plans.
• Developed goals and managed performance expectations for 2 MS level research associates.

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• Micro-fabricated UV-embossing micro-molds for display application.
• Analyzed >2000 US and Finnish diabetic subjects; completed a project funded by Juvenile Diabetes Research Foundation.
• Served as lead scientist to evaluate and modernize a forced lung maneuvers method to support an inhalation initiative.
• Interfaced with winch, launch and recovery system, ROV and AUV manufacturers and with company's fabricators.
• Invented of a patented thermal transfer overcoat for the Opal media providing UV protection, and improved handling.
• Led a Successful team effort to develop UV-curable ink jet ink designed for a commercially available printer.
• Participated in the design and development of a prototype lamp source to cure low viscosity UV ink.
• Implemented PAT methods (FTIR, UV) and statistical methods that improved sample turnover times.
• Worked on team inventing a UV curable lithographic printing plate that required no external development.
• Managed UV-recording Holography Lab (HeCd Ar+) for nearly two years.
• Developed ultraviolet (UV) curable coatings to protect fiber optic cables.
• Handled robotic liquid handling system as well as UV/visible and fluorescence spectroscopy.
• Identified UV stabilizers that did not react with the formulation catalyst package.
• Identified the negative impact of UV and ozone on conductivity of HIL.
• Developed UV-cured, custom-printed duct tape and process.
• Implemented the UV curing systems.
• Inserted nastic actuators into proprietary morphing surface design for DoD mission critical application (quiet submarine maneuvering).
• Developed UV-curable, non-hazardous coatings without photoinitiator, allowing for application outdoors and in food packaging.
• Invented and designed miniature UV-VIS Fourier Spectrometer for multi-channel wafer plasma etching diagnostics.
• Developed innovative multiplexed cell based vaccine adjuvant screening system.

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• Generated and executed non-clinical pharmacology study protocols.
• Crafted consumer study protocols and questionnaires.
• Generated reports, study protocols, memos, and white papers for regulatory submission, marketing claims, and sales training.
• Reviewed clinical study protocols and prepared clinical drug product shipments for global study sites to enable new product development.
• Authored study design templates used by CRO Study Directors to produce study protocols for contracted studies.
• Provide guidance for CRA s regarding study protocol requirements (patient enrollment etc).
• Prepare study protocols and submit to CRO for animal study.
• Designed and authored study protocols and report data tables.
• Trained and coached lab members of study protocols.
• Drafted proposals, study protocols and reports.
• Study protocol review and set-up.
• Manage study protocols and study conduct, intimately involved in the toxicology and pharmacokinetic study protocol development process.
• Assisted with creating/authorizing controlled methods, the preparation of study protocols and analytical/validation plans and reports.
• Reviewed and approved analytical development, validation and stability study protocols and reports.
• Draft standard operation procedures (SOPs), training protocol, study protocols, and IACUC protocols.
• Authored regulatory documents including SOPs, user guidelines, study protocols, and validation reports.
• study protocols, Informed Consent Forms etc (QC)
• Authored and implementation SOPs and special study protocols.
• Reviewed pre-clinical study protocols; created pharmacokinetic analysis reports using Microsoft Excel, based on data generated from studies.
• Conducted, oversaw and ensured validations and sample analysis performed as per study protocols/analytical plans and SOPs.

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• Assumed area management of stability chambers, initiated critical work to be performed, and reviewed physical inventory of stability samples.
• Prepared gap method validation report and tested stability samples for dissolution of soft gelatin capsules using Apparatus-III.
• Initiated stability study; pulled stability samples and tested according to approved procedures and specifications.
• Analyzed physical and chemical testing of product stability samples in accelerated conditions.
• Tested routine stability samples in managing stability program.
• Performed appearance, weight loss, and dose accuracy analysis of the stability samples and assisted with broaching experiments
• Coordinated Testing of Validation samples on solid, liquid and aerosol product release along with stability samples.
• Performed testing of stability samples in the Phase III stages.
• Performed testing for development, release, and stability samples.
• Identified unknown peaks from stability samples.
• Maintained stability chambers and provided scheduled stability samples for analytical testing to ensure completion as per due dates.
• Analyzed R&D analytical stability samples, clinical samples and product development samples.

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