Top 50 Senior Scientist Skills

high Demand

• Direct organic synthesis projects for process improvements and manufacture of PanVera drug discovery products.
• Core responsibilities: Timely synthesis of anti-bacterial compounds to support multiple partnered programs.
• Synthesized small molecules for custom synthesis organization.
• Glass production, chemical synthesis, polymers, life sciences, transportation, fiber, HPFS and environmental problems solved.
• Played a key role in design and synthesis of a number of active and lead-like structures.

• Led a team in the development of a 10-step synthesis of a new active pharmaceutical ingredient.
• Developed an innovative and green synthesis route for making a mining reagent without using odorous reagents.
• Set up organic synthesis lab and initiated start-up of a new business unit.
• Implemented the synthesis on kilogram scale to deliver 400 grams for formulation development.
• Experience setting up a 20-50L and 100L glassware lab for mid-scale synthesis 6.

• Recruit, train and direct associate scientists involved with organic synthesis projects.
• Monitored disappearance of reagents and appearance of product/by-products in solution during solid-phase synthesis using UV/vis spectroscopy.
• Developed a new synthetic method that allowed the synthesis of C6-substituted pyrrolopyrimidines.
• Supervised CROs for custom synthesis of advance intermediates/cores as desired for projects.
• Devised an efficient parallel synthesis for C7-modification on the pyrazolopyrimidine core.

• Developed an efficient synthetic method for a novel, synthetically challenging hydroxytetralin purinone via 11-step synthesis.
• Achieved the total synthesis of chiral macromolecule NXL-104.
• Design and synthesis of bioisosteres of salicylates.
• Prepared a synthetically difficult and novel scaffold, spiro-cyclopropyl benzazepinone, via multi-step synthesis.
• Constructed the integration and episomal vectors with codon- and expression-optimized bacterial and fungal genes/proteins for butanol biosynthesis and redox balance.

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high Demand

• Perform HPLC validations and reference standard certifications.
• Performed protein characterization by RP-HPLC.
• Led the manufacturing setup, verification and validation of the ?KTA Pure 25 HPLC system with 6.3 Unicorn software.
• Optimized X-PEG-Y configuration of reactive groups and protein coupling protocol following the reactions by SEC HPLC.
• Developed narrow pore and wide pore silica gel to be used as HPLC packing materials.

• Developed number of HPLC/UPLC, SEC methods to investigated proteins degradation and aggregation.
• Analyzed the concentration of Active Pharmaceutical Ingredients in Surgical Scrubs via HPLC.
• Oversee equipment IQ/OQ/PQ and calibration of HPLC and dissolution systems.
• Characterized intermediate and target compounds via 1H NMR and HPLC/MS.
• Applied HPLC results to understand impurities formed from coating interactions.

• Trained distributors on operation and maintenance of the HPLC systems.
• Executed synthesis, characterization, and HPLC method development.
• Developed solid phase extraction/HPLC assays for pharmacokinetic and drug metabolism studies in animals.
• Assessed stability of paclitaxel analogs and gold-bound analogs utilizing RP-HPLC.
• Managed HPLC test method life cycle for protein/process development and method transfer to CMO for phase 2 and approved biologics.

• Purified proteins and conjugates - LC (gel-filtration, affinity), TLC, HPLC, and gel electrophoresis.
• Acquired analytical instruments including HPLC, prep-HPLC, LC/MS, NMR, UV/Fluorescence spectrometer, and automatic flash column.
• Performed tandem-HPLC analysis in support of proteomics initiative Learned fundamentals of ICP-MS to lead team on heavy metal remediation initiative.
• Used and maintain laboratory equipment Rainin reverse and normal phase HPLC, LCMS, Varian NMR, IR.
• Validated the rhCYP isoforms using standard probe substrates and HPLC analysis.

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high Demand

• Represented Immuno-Oncology group as a scientific lead and collaborated closely with clinical development, product development and business development teams.
• Engaged in business development activities including general marketing; networking; proposal writing and development; and presentations.
• Coordinate and communicate with clients, establish partnerships and market company technology at scientific and business development conferences.
• Support business development and technical marketing through product demonstrations, customer training and special product applications.
• Developed and initiated business development strategies for service line expansion throughout eastern North Carolina.

• Collaborated with executive staff regarding business development efforts including in-person corporate capabilities presentations.
• Direct responsibility for project management and business development throughout North Carolina.
• Coordinated with multiple SAIC divisions and outside contractors for business development.
• Assisted with proposal writing and other business development opportunities.
• Evaluate research proposals with business development department.

• Performed due diligence with the Business Development team to assign valuation to scientific assets for potential deals and acquisitions.
• Provided customer support, and software training and demonstration support to sales, marketing and business development groups.
• Worked closely with the Legal and Business Development group on all questions concerning the IgG expression platform.
• Supervised teams of five staff on multiple projects, overseeing program management and business development activities.
• Participate in the selection of response to RFP's for future business development for transportation projects.

• Acted as a scientific consultant at the interface with the marketing and business development department.
• Perform business development trips to various external customers; highlighting the division services.
• Led the office's business development committee.
• Advised the client about business development.
• Supported business development for partnering gevokizumab (anti-IL-1 antibody).

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high Demand

• Compiled supporting documents for FDA inspection and investigation of data for response to audit observations.
• Provided support during FDA audits of departments within Pre-Clinical Development.
• Reviewed and evaluated FDA regulatory requirements for continued compliance.
• Ensured regulatory compliance with IND filing, End of Phase 2 FDA meetings, and follow-up regulatory documentation.
• Conducted and documented BUN and glucose interference study for FDA/510(k) studies resulting in approval.

• Partnered with FDA statisticians during protocol design, analysis and submission phases of submissions.
• Increased the reliability and quality of company operations in compliance with FDA requirements.
• Insured compliance with GMP, preventing FDA citations, as Internal GMP auditor.
• Set up system of QC and QA in compliance with FDA Regulations.
• Presented at internal meetings with the FDA Center for Veterinary Medicine.

• Provided technical expertise to two successful FDA inspections.
• Authored sections for FDA submission.
• Implement guidelines to make sure company complies with USDA, FDA, AAALAC, ISO, OSHA and NIOSH regulations.
• Performed quality control of cancer vaccine products for FDA regulated GMP manufacturing facility.
• Possess solid knowledge of pre-clinical and clinical study guidelines, regulatory affairs, and the FDA submission process.

• Ensured compliance with QSRs as well as ISO and FDA/DEA/GLP/GMP regulations in all activities.
• Collaborated with ELISA improvement team resulting in FDA licensure.
• Supported PAI & cGMP inspections by FDA & other BoH.
• Research and development of FDA regulated in vitro diagnostic assays (aerobic and anaerobic microorganisms and Mycobacterium tuberculosis).
• Authored in vivo sections of ZEFTERA(TM) and DORIBAX microbiology summaries, meeting FDA submission deadlines.

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high Demand

• Developed modules for performing water quality data analysis in the classroom.
• Managed assay development, automation set-up and data analysis.
• Study design, planning, execution, data analysis and report generation; Provided guidance to team in execution and coordination.
• Write study protocols, data analysis sections and peer review publications (abstracts) or reports regarding trial results.
• Coordinated and executed field measurements for IMACC's customers, and assisted them in data analysis and report preparation.

• Improved efficiency for CAR-T process and product characterization, data analysis, summary and identifying trends.
• Invented a logic based real time data analysis for IMS/NCA/PID to trigger chemical detection.
• Performed MRM assay testing sample preparation, LC-MRM/MS data acquisition and data analysis.
• Base de Donne: Bilingual (French/English) on-line data analysis site.
• Performed data analysis and weekly reviews with the team.

• Experience with NextGen data analysis.
• Performed pharmacokinetic data analysis to support non-clinical and clinical trials for large and small molecule drug development at TEVA.
• Study Design and Data Analysis: Performed non-compartmental and compartmental pharmacokinetic analyses for clinical and nonclinical studies.
• Orchestrated scientific research and statistical data analysis for musculoskeletal tissue repair.
• Oversee development of data analysis plans by biostatistician.

• Increased the rate of data analysis in cooperation with the IT Department.
• Mass Spec data analysis using different proteomic tools and writing reports.
• Developed data analysis method and created prototype software for fluorescently tagged miRNA/protein/DNA assay.
• General Activities: Genomics, RNA expression profiling, DNA sequence analysis, and flow cytometry data analysis.
• Authored internal SOPs and guidelines for pharmacokinetic data analysis, data collection processes, and NONMEM data preparation.

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high Demand

• Conducted clinical trials with Cleveland Clinic and University Hospitals of Cleveland.
• Interfaced with upper management, Marketing, and Regulatory Affairs through project updates, focus groups, and clinical trials.
• Received a patent for synthesizing a lens polymer, moved prototype through clinical trials, and transferred to manufacturing.
• Team evaluated late stage experimental compounds in support of clinical trials and project teams in these models.
• Coordinated clinical trials, pilot studies and developed commercialization options in dairy milk and buttery spread products.

• Core member in the development of one lead compound PL-3994 in clinical trials for the CHF project
• Transferred processes to pilot plant scale for clinical trials (Phase I & II).
• Interacted with the regulatory and clinical group to support the initiation of clinical trials.
• Served as point of contact for numerous concurrently ongoing clinical trials.
• Consult with Pharmaceutical companies performing Phase III and IV clinical trials.

• Developed protocol and prototypes for a number of clinical trials.
• Co-discovered first-in-class CX-4945 currently in phase I clinical trials.
• Developed species-specific antibody assays to support pre-clinical, epidemiological and clinical trials.
• Performed final PV on pivotal rat DMPK and electrophysiology studies for CX-717, which then went to phase two clinical trials.
• Optimized a lead compound to a potent pre-clinical candidate which progressed into animal safety toxicology and into Phase II clinical trials.

• Advanced XMT-1107 to Phase 1 clinical trials, a polymer-conjugated fumagillol derivative for patients with advance solid tumors.
• Supported XMT-1001 Phase 1 clinical trials, a novel polymeric camptothecin pro-drug for patients with advanced cancer.
• Designed pilot human clinical trials to study in vivo effects of nutritional supplements.
• entered Phase I clinical trials in 2010.
• Scaled up purification process in cGMP area to recover purified recombinant plasminogen ( ~35-40 g/batch)for Phase II clinical trials.

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high Demand

• Consulted for Exploratory Chemistry and High Throughput Organic Synthesis groups, triggering MolecusetTM with eventual size of 120,000 discrete 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.
• Involve in developing new HPLC columns for separation and analysis of bio- or small molecules.
• Conducted hit to lead and lead optimization of small molecules.

• Designed and participated in synthesis of 2 classes of novel dual-acting small molecules with simultaneous anti-inflammatory and bronchodilatory efficacy.
• 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.
• Research, design, synthesis and characterization of active organic materials based on polymers and small molecules for Organic Photovoltaics.
• Executed pipeline support through ADME and PK characterization of small molecules and mAb from discovery through early stage development.

• Developed and validated purity and potency RP-HPLC methods for small molecules and peptides in support of new pharmaceuticals.
• proposed and led group to test small molecules for inhibition of TGF.
• Maintain lab libraries of cell lines, small molecules and DNAs.
• Immobilized proteins/peptides/small molecules to chromatography media for affinity purification and protein pull down.
• Led HPLC and MS directed HPLC purification of small molecules, peptides and metallopeptides to support drug discovery and development.

• Led and delivered 4 projects on nucleosides and small molecules against HCV with both internal sources and external CROs.
• Develop methods for the bioanalysis of small molecules and peptides by LC-MS/MS.
• Designed and synthesized novel organic small molecules and oligomers as precursors or cross-linkers for water based UV and/or thermo-activated sealing formulations.
• Evaluate small molecules and biologics from different chemical classes in an in vitro assay that better represents an in vivo system.
• Optimized assays for differentiation of mouse ES cells to embryoid body-dervied cardiomyocytes for highthroughput cardiotoxicity assays of small molecules.

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high Demand

• 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.
• Directed the planning, development and operations of Chemical and Biological intelligence programs.
• Supported data collection and participated in cross-functional project teams and management.
• Increased the effectiveness of current programs, evaluated the feasibility of future programs and developed plans to meet mission objectives.

• Developed tools to optimize algorithms and verify their relative merits through the offline processing of field data.
• Developed performance demonstrations and claims for Monarch Crown (military PX line) laundry and household cleaners.
• Focus on leading research teams developing early/late process projects to scale up in the pilot plant 2.
• Completed the UMTS LMU specification as approved by 3GPP through performing/presenting required simulations and work items.
• Worked on identifying larval fishes collected from studies on power plant cooling water intake systems.

• Developed new products to support the Drug Delivery Systems (DDS) group.
• Evaluated, Improved and deployed processes and systems.
• Played key role in building the internal database and infrastructure (LIMS) for the analytical data.
• Collaborated with U.S Army Corp of Engineers to optimal design and operation of smart grid systems.
• Presented pharmacokinetic results, PKPD findings, and new technology to the department or project teams.

• Redesigned LIMS, high-throughput (HTP) protocols, workflow and sequence analysis tools.
• Designed, tested and implemented process workflow, supporting LIMS and sequence analysis.
• Piloted the RENUZIT Air Freshener control release systems that became plug-ins.
• Work in cross-functional teams to transfer test methods, meet project deliverables and timelines.
• Lead user for formulary software systems providing training to all other team members.

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high Demand

• Provide scientific expertise on federal and commercial research projects, including proposal reviews, study execution, and presentations to stakeholders.
• Experienced in leading high visibility research projects and assisting management in setting strategic technology direction for the company.
• Conducted microbiological research projects involving microbiological characterization and growth patterns of starter cultures and/or contaminants.
• Performed elaborate literature surveys for designing research projects.
• Supported research projects at WPAFB using computer-modeling methodology.

• Analyzed targets, market opportunities, medical needs and competitor's product development to identify and define new research projects.
• Project manager various government research projects with typical budgets of $1-3M, including a large budgeted DARPA project.
• Used in various research projects, and transferred to Philips Lifestyle business for product development.
• Initiated, planned and conducted research projects and reported to Science Board and grant agency.
• Managed as Principal Investigator of research projects funded by US government agencies.

• Participated in various research projects as a task lead or technical expert.
• Managed associate scientists: direct day-to-day activities and guide research projects.
• Facilitated for a $750K research projects and supported 10+ associates.
• Supervised master students in their research projects.
• Led the Molecular Pathology group in pathology-based translational research projects.

• Recruited to lead research projects, manage research associates, and to support various functions of biotech nanotechnology start-up.
• Plan, design and execute research projects to enhance in-house capabilities and for business development.
• Lead Scientist of recombinant and live-vector vaccine research projects.
• Initiated novel research projects and developed an exosome-based technology platform called Exosome Display to broaden the company's pipeline of products.
• Led/designed research projects to evaluate new equipments to improve lunchmeat production efficiency.

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average Demand

• Work cross functionally with Regulatory, Process Development, and Quality to support commercialization and marketing application filings.
• Supervised and developed research associates, pursued cross-functional research, and interacted extensively with suppliers and vendors.
• Examined tumor microscopically for content, classification, and staging.
• Navigated complex regulatory requirements across multiple countries.
• Participated in cross-functional teams and with adhesive co-suppliers for material development analysis for use in personal care and child care products.

• Worked with a cross functional team for filing, commercialization, and response to questions for first in class molecule.
• Coordinated cross function, cross sites, and internal-external sample management for the LRRK2 project.
• Led cross-functional global research and development team for strategic planning of future research direction.
• Coordinated cross function activities for the Lead Optimization of TRA project.
• Model was very successful it was implemented across the division.

• Awarded for cross-functional team participation to develop toxicity biomarkers for Alzheimer's therapeutic.
• Led local multi-disciplinary teams and participated in cross-functional teams.
• Standardized the data collection process for CROs who provided data for Toxicology, QWBA and Metabolism studies.
• Lead a cross-functional team with members from Bioscience, Toxicology, Strategic Alliance and Product Development.
• Represented the Analytical Sciences group in cross-functional meetings to plan experiments and discuss results.

• Developed cross functional network across the company, ie multiple sites and departments.
• Coordinated projects (Asthma, Transplantation) in preclinical development within cross-functional teams.
• Evaluated, validated and selected global CROs to support global BE studies.
• Pioneered the use of confocal microscopy and other neuroscientific functional analyses of mechanisms in the behavior ecology discipline.
• Supported development and troubleshooting of antibody purification, peptide mapping, protein microsequencing, ELISA, endotoxin clearance.

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average Demand

• Developed protocol for Mass Spec based protein identification of Membrane proteins and successfully performed GLP validation required for Regulatory safety studies.
• Provided nonclinical Good Laboratory Practice (GLP) safety pharmacology studies to advance compounds in development.
• Established timely and qualified contract work for outsourced GLP studies through partnership with Legal, Procurement and QA departments.
• Monitor the conduct of contracted toxicology studies to ensure adherence to worldwide GLP regulations.
• Acted as study coordinator in Good Laboratory Practices (GLP) study environment.

• Supported all non-GLP and GLP toxicology including acute, sub-chronic and chronic studies.
• Retain in depth knowledge about Good Laboratory Practices (GLP)
• Experienced in GLP, GMP and pilot line manufacturing.
• Implemented and managed all GLP processes for method development and method transfer of all bioanalytical activities to these sites.
• Performed and reviewed documentations in accordance with SOPs, GLP, internal guidelines and additional sponsor requirements.

• Designed & completed 30+ in-house PK/PD/Tox studies (GLP & non-GLP) as Study Director.
• Maintained GLP Master Schedule of ongoing toxicokinetic studies in preparation for FDA inspections.
• Designed and oversaw in-house studies and GLP studies performed by CROs.
• Complete development and oversight of GLP preclinical studies.
• Develop and write SOPs, GLP compliant.

• Managed upkeep of four research laboratories (including GLP-compliant laboratory) and associated apparatus for pre-clinical research.
• Represented Bioassay department at internal meetings with GLP-QA, Pharmaceutical Development Compliance, and Lab Asset Management and Validation Engineering teams.
• Evaluated vendor SOPs, test methods, procedures, reports, special studies and investigations for cGMP and GLP compliance.
• Coordinated and monitored over 14 projects requiring GLP bioanalysis (LC/MS/MS) for pre-clinical toxicokinetic studies.
• Functioned as an analytical chemist in a cGLP and cGMP quality environment.

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average Demand

• 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.
• Led validation studies and championed targets to governance committees, resulting in targets entering the drug discovery portfolio.
• Drive early stage drug discovery programs to achieve project goals starting from Lead identification to lead optimization.
• Worked in small molecule drug discovery for regulation of gene expression in a number of therapeutic areas.

• Cloned and expressed a wide variety of lipid modifying enzymes for drug discovery.
• Project lead on small-molecule drug discovery programs.
• Supported drug discovery projects at all sites.
• Report to VP of Drug Discovery.
• Designed and developed synthetic strategies, synthesized, purified and characterized conjugated proteins and peptides for oral drug discovery evaluations.

• Designed, validated and conducted cell-based and in vitro assays in support of cardiovascular drug discovery programs.
• Key Achievements: * Co-developed innovative approach to Fragment Based Drug Discovery using capillary electrophoresis screening technology.
• Managed drug discovery projects, optimized lead compound for preclinical study, supervised associate scientists.
• Supported drug discovery and drug development teams in drug metabolism and pharmacokinetics.
• Generated 12 stable HCV and BVDV replicon cell lines for development of new cell-based assays that supported HCV drug discovery.

• Group Leader: Nicotinic Drug Discovery Program.
• Advanced integrated technology automation supporting pre-clinical antipsychotic drug discovery.
• Led a multi-disciplinary team for pre-clinical drug discovery and development effort.
• Invited Scientist (2005-2006) Served an instrumental drug discovery role leading development and evaluation of anticancer drugs utilizing high-throughput screening.
• Established a new oxidative phosphorylation (OxPhos) based drug discovery platform for new therapeutic agents against infectious diseases and cancer.

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average Demand

• Participated in the design of a BL-2 pilot scale facility for the production of GMP vaccine.
• Provide training related to cleaning process performance and execution as part of the GMP certification Program.
• Worked in the GMP environment dedicated to high quality and timely scientific results.
• Assisted with technology transfer in preparation for production in the GMP pilot plant.
• Conducted investigation of unexpected impurities in GMP production of a new drug candidate.

• Supervised and trained laboratory staff, including scheduled, organized, and monitored laboratory work in a cGMP laboratory setting.
• Performed deviation investigation and resolution resulting in the release of GMP batches and payments to Lonza.
• Evaluated CMOs then championed technology transfer and scale-up from lab to GMP production at 5m3.
• Supported ISO9000 and GMP certification with SOPs, batch records and instrument certification.
• Authored the master change control decontamination for gMP lab equipment move.

• Assembled and qualified equipment to establish cGMP facilities for Cambridge location.
• Trained in current Good Manufacturing Practices (cGMP).
• Conducted internal audits for safety and cGMP compliance.
• Lead analytical chemist in GMP reference standard qualification; coordinated all analytical activities and generated CoA for QA review.
• Cloned and expressed recombinant antigens for manufacturing support under GMP and strict quality guidelines for immunoassay development.

• Developed a robust and scalable crystallization procedure from aqueous solution for GMP production of a new salt form at kilo scale.
• Lead scientist responsible for the organization and management of the new cGMP injectable manufacturing business unit.
• Project Leader for multiple preparative HPLC purifications of intermediates and final products under cGMP conditions for Phase I/II clinical trials.
• Perform experiments in compliance with the guidelines for current good manufacturing (cGMP) practices using analytical instruments.
• Set up clinical manufacturing practices to be in compliance with cGMP guidelines.

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average Demand

• Used DNA extraction, PCR and molecular cloning to investigate circulating DNA changes promoted by gamma irradiation in rats.
• Developed FFPE RNA and DNA library preparation methods for high-throughput NGS sequencing, including target enrichment methods.
• Developed a scaled and robust protocol for Phi X-174 RF DNA production.
• Trained and supervised research associates to establish the standardized protocols for preparation of normalized and subtracted cDNA libraries.
• Provided quantitative mitochondrial DNA damage assays for a major pharmaceutical company.

• Ensured the successful detection of RNA by creating 100+ DNA constructs/plasmids expressing variants of required components in only six months.
• Developed prostate panel genes Repeat Depleted DNA probes that were used to detect ETS gene rearrangement in prostate cancer.
• Perform NextGen sequencing for RNA and DNA, shot gun and amplicon based, using Roche 454 platform.
• Developed two patents as a result of recombinant DNA technology research.
• Developed cell-based ELISA, functional ELISA Sandwich ELISA and DNA-binding ELISA.

• Constructed plant transformation vectors for transposon and T-DNA gene tagging.
• Designed and implemented small linux cluster for DNA sequence analysis
• Substituted pyrido[2,3-d]pyrimidines were synthesized as NAD+ DNA ligase inhibitors as antibacterials.
• Construct cDNA and gDNA libraries with or without sequence capture enrichment process.
• Developed a unique isothermal DNA sequence detection method using a chemiluminescent microparticle agglutination assay (the LOCI technique).

• Experience in running instruments like Biomek FX, Biomek 2000, DNA synthesizer, CEQ-8000, Capillary Electrophoresis and HPLC instruments.
• Led effort to identify modification to increase the binding affinity of oligos to genomic DNA via modifications similar to LNAs.
• Graduate and Undergraduate Researches 1989-2006 DNA adducts structure identification using exonuclease digestion coupled with LC/MS.
• Constructed and screened a representative genomic and cDNA libraries of nuclei/immature endosperm of hexaploid wheat; mapped the wheat genome.
• Established recombinant human (rh) CYP-isozyme banks (from cDNA expressed E.coli cells) for routine drug metabolism studies.

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average Demand

• Provide process/product development, technical support and improvements to product lines manufactured at ADI operations including design and development plan.
• Provided technical support for Bristol-Myers Squibb manufacturing sites and Quality Control management groups to improve manufacturing and laboratory capabilities.
• Provided technical support and advice in areas of expertise to Engineering Management.
• Provide technical support and recommendations in resolution of recognized environmental conditions.
• Provided technical support for in house reagent manufacturing.

• Assisted internet marketing and technical support.
• Provided technical support for antibody products both directly with customers and through training of the Technical Service group.
• Conduct research and development resulting in ELISA kits for commercial market and provide technical support to customers.
• Functioned as technical liaison, supplying technical support during the launch of new products.
• Interacted with Division personnel, plant management, instrument suppliers and technical support teams.

• Provided technical support to commercial team in order to increase business growth.
• Played key role and provided technical support in two FDA inspections.
• Point of contact for technical support and issue resolution.
• Coordinated technical support functions for customer hot line.
• Provide technical support for process chemistry related issues.

• Led consulting projects and technical support to sales.
• Provided technical support to manufacturing, formulation department and supervised 4 chemists within formulation and analytical groups.
• Trained, supervised, and managed three technical support staff.
• Provide technical support to commercial development and world wide business management for introduction of new products.
• Provided Manufacturing technical support on dye-labelled phosphoramidites, oligonucleotides labelling reagents.

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average Demand

• Developed an ELISA-based assay for drug efficacy studies, performed potency assay analysis and compiled method development report incorporating GMP/GLP guidelines.
• Read ELISA plates by Molecular devices SoftMax Pro (5 parameter logistic analysis) and had introduction to Watson program.
• Developed cellular IF assays, reporter assays, ELISA assays, ELISPOT assay, and others.
• Performed cell and tissue culture, protein purification, cell cloning, HPLC and ELISA analysis.
• Developed and performed troubleshooting for ELISA assays for clinical trial phase II for viral vaccines.

• Skilled in aseptic techniques, ELISA, and cell culture preparation.
• Managed and lead product development for Multiplex Array based ELISA.
• Optimized a diagnostic assay (ELISA) for commercial purposes.
• Optimized and validated ELISA (PLISA) and solution assays.
• Developed new self-performing ELISA/EIA assay product concepts.

• Executed ELISA assays for FDA studies.
• Developed ELISA and enzymatic assays to test biological activity of recombinant proteins.
• Developed and validated human Galectin-3 ELISA assay for quantitation of clinical trial patient serum galectin-3 level in GCS-100 clinical trial.
• Developed equipment cleaning validation FDA response for IMx HBsAg ELISA/EIA assay, thus meeting FDA requirements.
• Directed the immunological assay team in developing ELISAs for pre-clinical and clinical studies.

• Developed ELISA, Flow cytometry and Cell-based immunoassays to characterize the antibodies.
• Developed enzyme linked immunoassays (ELISAs) for measurements of hormones.
• Characterized polyclonal and monoclonal antibodies for common cold rhinovirus by Western Blot, ELISA, and neutralization assays for vaccine development.
• Developed and qualified ELISA assays for secretion of eicosanoids and cytokines from human monocytes for the company screening program.
• Test dose response of various vaccine candidates by ELISA, Flow Cytometry, or chemiluminescent assays for various cytokines.

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average Demand

• Performed QC stability and sterility testing of finished manufactured products.
• Established in house utility-driven QC program and method development.
• Developed QC methods and specifications for mechanical properties.
• Conducted QC product release, stability testing, results analysis, and data management for all marketed PCR diagnostic products.
• Reviewed and QC'd DRAFT and FINAL reports to ensure scientific validity and adherence to regulatory standards and conventions.

• Gap Analysis in AD, QC in order to bridge deficiencies to GMP standard.
• Trained and mentored the whole QC group on this project.
• Lead scientist for IVD reagents QC method development and troubleshooting.
• Review QC test data for product approval and release.
• Involved mainly with IQC protocols and new material qualifications.

• Experienced hands on Pharmaceutical R&D and QC.
• Certified NJPQCA and active member of safety inspection committee.
• Involved heavily in the QC process of projects.
• Compounded bulk reagents and performed QC testing.
• Represented analytical (QC/R&D) department in Global Technology Team (GTT).

• Transferred cell-based and residual EIA methods to manufacturing QC labs for potency and product residuals.
• Performed final QC/QA on all products created within the Advanced Geospatial Division.
• Developed methodology for QC of inkjet paper and inks manufacturing using ISE: Resulted in reduction of wasted paper production batches.
• Perform Luminex-based multi-plex assays and opsonophagocytic killing assays for non-clinical and clinical testing with subsequent review and QC of generated documentation/data.
• manufacture, packaging and QC batch release) Assessed and remedied the current analytical test method weak point (AWP).

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average Demand

• Project Management and Leadership o Communicate effectively and routinely with customer or project stakeholder, project team members, and superiors.
• Familiarized with Project management schedule, Lotus and Statistic software for management skill and data manipulation.
• Provided high-level project management consulting services for development of custom technology solutions for DOD network defenses.
• 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.

• Provided constructive recommendations to project management team for diabetes & oncology drug development.
• Sharpened hands-on and strategic project management.
• Project management for overseas collaboration.
• Developed integrated project plan and development strategy in collaboration with global Project Management Office (PMO).
• Project management including; budget, schedule, team orientation, report writing and proposals writing.

• Project management (forecasting, budget, preparation of project plan and reports, etc.)
• Account / Project Management requiring strong Client Communication skills through written, verbal and face-to-face meetings.
• Project management of new product and product enhancement studies and development.
• Used project management to guide teamwork on validation and production trials.
• Selected to Parsons Project Management Certification Program - May 2012.

• Lead core team technical discussions with process chemistry, analytical chemistry, QA, clinical and project management.
• Project Management tools (Microsoft Project and Visio), techniques and processes.
• Demonstrated mastery of project management procedures and software, including requirements management, budgeting and accounting, and earned value management.
• Provided team leadership and project management skills in microbial discovery and genomics of microbiome.
• Project Management & Business Development Assisted clients with energy infrastructure projects Pipelines Gas Processing Plants Wind Energy Conversion Projects

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average Demand

• Authored reports on assay development, molecular biology and laboratory protocols and drug target discovery.
• Cell-Based assay development and drug screening: Part of a multidisciplinary scientific team with task to develop and review candidate drugs.
• Review raw material testing assay development report and other technical reports if any.
• Interacted with clients on results of all stages of assay development and screening.
• Characterized polyclonal antibodies produced by vendors for 2 projects allowing for assay development and tissue distribution of targets.

• Managed group of scientists and associates that directed bioassay development, qualification, and validation activities.
• Managed assay development and animal model development resources within a matrix environment to meet timelines.
• Utilized assay development matrices to optimize staining protocols for biomarker detection in diagnostic samples.
• Served as Laboratory Supervisor for Research and Development pre-clinical and assay development studies.
• Initiated a microfluidic, non-invasive IVD assay development for cancer and prenatal diagnostics.

• Project: Method and assay development for the single molecule DNA structural analysis and mapping by fluorescence imaging in nano-fluidic channel.
• Established assay development capabilities at Flanders facility, developed Estradiol assay with high dynamic range and sensitivity for IMMULITE 2000TM system.
• Worked as a part of a team to develop the SOPs for MRM assay development and testing.
• Process improvement projects for existing tests and assay development projects for new tests.
• Be responsible for animal model development, biomarker development, bioanalytical assay development and drug safety and toxicity studies.

• Monitored bioassay development, validation and sample analysis at CRO insuring CRO delivered high quality data within project timeline.
• Developed LC and HPLC method for purification of recombinant protein for immunoassay development.
• Performed assay development using spectrophotometry and flow cytometry.
• Assay development included Ferritin, Folate, FSH, TSH, Chlamydia.
• Cloned, expressed and purified hundreds of recombinant antigens, including various cytokines, hormones and receptors for immunoassay development.

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average Demand

• Conducted screening level risk assessments, for several parcels in preparation for transfer to local community for future commercial/industrial use.
• Performed independent technical and quality assurance reviews of data packages completed by other production chemists.
• Established two novel over-circulation induced pulmonary artery hypertension models in piglet.
• Identified and recruited service providers from universities, labs, and corporations in US, Canada, Western Europe and India
• Perform statistical analysis of these trials and work as an intermediary with private physician practices and the pharmaceutical industry.

• Support Regulatory Affairs on IND and NDA submissions; Discussions for Chemistry, Manufacturing and Controls Information Section.
• Respond to federal and industrial announcements for directed R&D.
• Communicated with individuals and groups about the projects progress.
• Provided on-site technical and programmatic evaluations of numerous performer organizations at the Service Laboratories, Industry, and Universities.
• Established a novel mechanical injury induced femoral artery restenosis model in mouse.

• focus on human factors and individual instructional technologies.
• Supervised a group of 14 individuals (direct reports) composed of both company employees and full time contract workers.
• Assisted in filing IND application for Icotinib, a non-small cell lung cancer drug developed by BetaPharma.
• Developed surface modified particle products (4 series, 20+ kinds) for immunoassay reagents.
• Developed and maintained ligand-binding immunoassays to suit client needs.

• Initiated the WINDEX outdoor window cleaner idea by investigating and identifying a no residue surfactant for the formula.
• Led generation of over 240 recombinant and mutant variants of industrial yeast strains.
• Supervised and managed Ph.D. chemists and CRO FTEs (India and China).
• Identified "inducers" were used to screen antibodies for potential clinical development.
• Identified several "inducers" causing tau pathology in an in vitro assay system.

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average Demand

• Managed service providers in the development of a rapid lateral flow device to create new diagnostic product for women's health.
• Developed a crystallization procedure for the API that increased the purity to a few percent above the specification requirement.
• Developed a process for crystallization of the API that met very tight purity specifications.
• Improved sample quality and developed unique products by exploring new techniques and rapid prototyping.
• Eliminated $4M warranty cost through rapid root cause corrective action investigation.

• Set up contract manufacture of the API.
• Instrument: API4000 QTRAP, API 4000, API 3000, and TomTech liquid handler.
• Developed novel nanocomposite materials for rapid manufacturing of medical devices using various Rapid Prototype and 3D printing technologies.
• Supervised and participated in multi-step preparations of API's and specialty chemicals.
• Developed high-throughput technique for dynamic space shaping of intense femtosecond laser pulses.

• Designed and validated rapid epitope determination platform.
• Initiate and finalize API and finished product specifications, working in collaboration with the analytical research and product development group.
• Participated in writing capital request, design, and equipment procurement for a biosafety level II cell culture facility.
• Led team to develop a serum protein profiling assay based on capillary electrophoresis and obtain 510k approval.
• Acted as liaison between formulation, API development groups and the facilities delivery group.

• Solved synthetic chemistry and processing problems that arise during preparation of APIs.
• Project leader for new API projects at Tetrionics.
• Established specifications, acceptance criteria, sampling and testing plans for APIs, excipients, in-process materials and finished products.
• Optimized a scale-up process of ring-closing metathesis reaction forming a 21-membered macrocycle as a precursor of an API.
• Confirmed the hypothesis in vivo and ex vivo to achieve rapid proof-of-concept including models development and biomarker identification.

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average Demand

• Nominated 14+ obesity/diabetes/CNS targets for high throughput screening initiation.
• Developed and validated high throughput screening assays.
• Patent: Methods and Systems for High Throughput Screening of Polymer Materials for Medical Devices (US 20070148697).
• Developed and validated high throughput assay formats for protein targets, including biochemical and cell based functional assays.
• Designed key steps of the 5-CF3 and 5-CN pyrimidine series synthesis, enabling it for high throughput synthesis.

• Received Bravo Award for constructing reporter cell lines used in high throughput assay development ahead of schedule.
• Identified compounds that inhibit Human Immunodeficiency Virus (HIV) by High Throughput FACS based Screening.
• Led six-member team of production chemists in multi-step synthesis of small molecule intermediates using high throughput/parallel synthesis methods.
• Developed and implemented generic HPLC and HPLC/MS/MS that supported high throughput discovery activities in Discovery.
• Implemented multiple SNP genotyping platforms and successfully implemented a high throughput SNP discovery pipeline.

• Built/supervised high throughput screening team and discovered human pancreatic lipase inhibitors.
• Participate in pharmacogenomics and high throughput assay development.
• Optimized cell based HTRF assays in 384-well format for high throughput screens to evaluate target engagement of an interested Kinase.
• Work on several platforms such as High throughput protein profiling RPPA and incucyte to collect large set of experiment data.
• Developed, validated, and conducted affinity selection mass spectrometry (ASMS) technology for high throughput drug screening.

• Developed two high throughput human primary T cell functional screen platforms in 1536 well format.
• Managed activities for high throughput SNP Discovery, Genotyping, and DNA Sequencing Department.
• Developed electrospray ionization Fourier transform ion cyclotron resonance mass spectrometry based assays for high throughput drug screening against RNA targets.
• Developed, optimized and validated in vitro kinase assay for high throughput screening.
• Explored new platforms of immunoassay (Gyros, Fortebio) for high throughputs, sensitivity, robustness and automation.

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average Demand

• Manage / conduct laboratory investigations both PCR and engineering based.
• Designed PCR experiments; performed DNA & RNA extractions and towards PCR based IVD.
• Support cross platform transfer / transfer of designs of RT PCR assay systems.
• Developed and utilized cell based assays to provide POC for various GPCR targets.
• Managed projects within cross-functional teams for the development of novel GPCR receptor agonists/antagonists for depression and anxiety.

• Initial studies included screening various antibodies for the IHC assay and several PCR primer sets for the qPCR assay.
• Develop and validate qPCR based high throughput multiplex assays for Companion Diagnostics using different cancer panels and FFPE tissues.
• Characterized DNA polymerases through Western Blot, SDS-PAGE, IEF, PCR, and enzymatic activity assays.
• Coordinated qPCR based transcription profiling activities across all ongoing internal programs (eight projects).
• Investigated the effect of proprietary platinum analogs via realtime PCR array platform.

• Explored GI tract orphan GPCRs, initiated screening and lead compounds ID.
• Isolated novel crystal toxin gene using PCR and rDNA techniques.
• Investigated the binding sites of MRL proprietary anti-diabetic AgoPAM/Partial/Full agonists using binding and functional assays on mutated GPCRs.
• Leveraged various platforms to isolate and characterize stem cells including immunocytochemistry, flow cytometry (FACS), and RT-PCR.
• Established and optimized Gq-IP-One, Gs-cAMP and pERK assays to profile and differentiate full and partial GPCR agonists.

• Used Degenerate PCR to learn more about the expression of orphan chemokine receptors and identified new chemokine receptors.
• Applied solid phase chemistry in the synthesis of potential peptide based GPCR agonists.
• Prepare cell banks & test for Mycoplasma via PCR and electrophoresis.
• Monitor kinetics of HBV replication by ELISA, qPCR, immunofluorescence, in situ RNA hybridization, Northern and Southern blots.
• Designed a new generation of Taq-based DNA polymerase for Fast Multiplex qPCR.

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average Demand

• Performed GC analysis in support of spontaneous combustion resolution.
• Developed, optimized and validated methods for materials analysis using TGA, GC, IC, FTIR, GC/FTIR/MS.
• Established, trained and led a high performance team to support CYP3A4 induction (PXR) GCS weekly assay.
• Designed and conducted studies on metabolism of munitions, pesticides and PCB using EPA HPLC and GC methods.
• Provided written/oral monthly updates to the GCS (Global Counter Screen) biology team.

• Performed projects employing and troubleshooting FAA, ICP, ICP-MS, and GC-MS methods.
• Conducted quantitative and qualitative analysis using RP-HPLC, HPLC/MS, GC, and FTIR.
• Studied the metabolism of explosive and their environmental metabolites using GC/MS.
• Synthesized and purified (HPLC and GC/MS) organic compounds.
• Developed GCMS methods for the identification of unknown residual solvents.

• Assisted in maintaining GCLP for the lab.
• Analyzed the products with LC-MS, HPLC, GC-MS and NMR.
• Characterized physical properties of polymers via thermal analysis and GC Improved procedures and performed method validation studies
• Perform impurities identification by GCMS and LCMS to support product development and analytical development.
• Provided structural information of unknown process related impurities and degradants using LCMS, GCMS and NMR.

• Process Development o Improved the processing of DNA synthesis with high and low GC content.
• Executed analyses on analytical instruments such as GCMS, HPLC, IR, AA, NMR, ELISA techniques, viscometers.
• Operated, calibrated and maintained Waters Acquity UPLC-UV/PDA, Waters Alliance HPLC-UV and Agilent HP GC-TCD/FID.
• Discovered the link between GCN2 and mTor in amino acid sensing.
• Experience with the Thermo Finnigan LCQ Deca Ion Trap LCMS and the Agilent 5973 GCMS systems.

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low Demand

• Prepared the technical reports presented to the ITU demonstrating compliance with international interference requirements for satellite slot filings.
• Prepared and presented detailed technical reports to senior management for experimental results and laboratory investigations.
• Prepare development proposals, execute protocols, and generate technical reports and regulatory submission documents.
• Author technical reports ready for regulatory submissions.
• Prepare technical reports to document field investigations.

• Authored validation protocols and technical reports.
• Conducted and supervised research; analyzed data toward project directed goals and milestones; wrote technical reports and created presentations.
• Contribute in writing scientific protocol/report/SOP, review of technical reports/SOP and summarize data as well as present at cross-functional meetings.
• Prepared proposal, technical reports, project progress reports and presented progress as per the project schedule.
• Prepared proposals, tracked financial status of programs, and prepared technical reports for government agencies.

• Led or substantively contributed to more than 6 technical reports in the last two years.
• Evaluated data and interpreted results to prepare accurate technical reports for ANDA submission.
• Analyzed data and authored technical reports for client and internal projects.
• Write Patents, SOP's, Protocols, and technical reports
• Prepared technical reports and monographs for IND submission.

• Perform, review and/or approve technical reports.
• Write technical reports, summaries, protocols, data analyses and SOPs.
• Author and review SOP's and Technical Reports Team leader for product degradation pathways study for BLA filing Experience:
• Author protocols, technical reports, SOPs, work instructions, and analytical standards.
• Conducted numerous leachate /extractable studies Wrote technical procedures and technical reports to meet appropriate regulatory guidelines.

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low Demand

• Supported development of a continuous subcutaneous insulin infusion device by performing analysis of commercial insulin dose formulations by HPLC.
• Negotiated pricing structure for LC/MS instrumentation directly with manufacturers at a corporate level.
• Designed and executed HPLC method qualification/validation; drafted qualification/validation report.
• Supervised installations and maintenance of LC/MS instrumentation.
• Conducted semi-quantification of total lipids by LC/MS and quantification of neutral lipids by LC/ELSD.

• Purified multiple grams of antibodies using AKTA FPLC.
• Identified critical flaw in HPLC packing equipment.
• Used WinNonlin to calculate PK parameters.
• Conduct method development or optimize/ troubleshoot client provided HPLC methods for assay/ stability analysis.
• Strategized the optimal approach and calculated potential solutions.

• Worked extensively with facilities management on the design and construction of a large number of dedicated LC/MS labs.
• Conducted extensive literature reviews to become Alcon Vision Care SME on long-term effects of HEVL on eye.
• Project scientist in: Technical production of aldehydes by continuous bleach oxidation of alcohols using 4-hydroxy-TEMPO.
• Research projects focused on the development of extremely rapid separations based on LC (i.e.
• Preformed HPLC method development to achieve the separation of impurities from the main component.

• Used untargeted data mining (MFE) and LC/MS/MS during discovery research.
• Developed and validated LC-MS/MS methods for APIs in biological samples Completed high volume biological sample analysis for PK/TK studies
• Developed the ultra-trace LC/MS proteomic analysis using 10 m i.d.
• Project scientist in: Efficiency & improvement in bio-fermentation of rhamnolipids biosurfactants, phenyl ethyl alcohol.
• Completed successful project for the analysis of amyloid-Beta isoform peptides and Apolipoprotein E protein with a nanospray -LC-MS-MS platform.

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low Demand

• Chaired internal and Joint Project Team meetings, provide agendas, issued minutes with follow-up actions identified.
• Coordinated external collaborations - Communicated weekly with partners to establish meeting agendas and mediate data discussions.
• Use Python with Pandas and Numpy packages to create multiple tools which reduce the processing time for quality assurance.
• Research Scientist Promoted 4 times in 8 years with increasing technical responsibility supporting line extensions (sNDAs).
• Accomplished development, Scale up and Filing of over 10 ANDAs / ANDS, including First-to-File applications.

• Prepared several Pharmaceutical Development Reports based on QbD and other filing documents for submission of ANDAs.
• Perform and report the necessary documentation to support regulatory filings such as IND and NDAs.
• Filed several ANDAs and commercialized one product (potassium chloride ER capsules from Watson).
• Assisted with the review, audit and editing of ANDAs prior to FDA submission.
• Authorized to handle DEA Controlled Substances Conceptualize and develop formulations for ANDAs from reverse engineered formulations.

• Developed, reviewed, and recommended scientifically-supported PK study bioequivalence protocols for ANDAs and some NDA products.
• Prepared PK reports for submission as part of ANDAs Client interactions and Project Management.
• Coordinated and prepared submissions for approval of investigational new drugs (INDs) and new drug applications (ANDA/NDAs).
• Participated in the preparation of regulatory submissions including Investigator Brochures, annual IND updates INDs, NDAs, and sNDAs.
• Prepare clinical pharmacology sections of regulatory briefing documents, INDs, CTAs, NDAs, MAAs and Japanese CTDs.

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low Demand

• Managed inventory of raw materials and newly manufactured products using SAP management system with minimal discrepancies, decreasing inventory costs.
• Analyzed formulations for stability claims, feasibility studies, shelf life determination and qualifications of raw materials.
• Delivered significant cost saving by improving manufacturing process and alternative raw materials.
• Performed identification testing of raw materials using Fourier Transform Infrared Spectroscopy.
• Performed qualitative and quantitative analysis of raw materials and finished goods.

• Developed procedures for the characterization of raw materials from vendors.
• 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.
• Conducted risk assessments from the process perspective when making changes to: installations, equipment, raw materials, etc.
• Provided specifications for raw materials and finished product offerings for products responsible for over 130 million dollars of company revenue.

• Arrange picking of new raw materials with scheduling, QC, or vendors, depending on the requested item.
• Developed, validated and transferred new methods for the analysis of finished drug substances and raw materials.
• Developed more robust calibrations for NIR library and quantitative methods for raw materials, improving quality.
• Manage >40000 catalog products, ~10000 raw materials, ~5000 notebook pages, 4000 projects,
• Specified and ordered required raw materials, tooling, and equipment for assigned projects.

• Performed tests in accordance with USP/NF guidelines on raw materials and finished OTC products.
• Interact with contract manufacturers to provide product and process specifications of formula * Entered formulas and raw materials into electronic database.
• Developed various grades of activated carbon, graphitic carbon and composite materials from bio-renewable raw materials.
• Performed analytical testing on raw materials and drug substances (i.e., testing for release, stability, and validation).
• Test and release raw materials/polymers for Santa Clara, Temecula sites.

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low Demand

• Utilized statistical analysis methodology (DOE) in process validation studies.
• Used Design of Experiments (DOE) software for synthetic process development and for determination of critical and optimal process parameters.
• Monitored leading opinions through interaction with academia, industry, and DOE, CDC, FDA and NIST.
• 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.

• Lead and conducted DOE studies for specific methods transiting from early phase to late phase.
• Research proposal writing and project management for DoD, DoE, NASA and other agencies.
• Guide research direction, monitor budgets and fulfill contractual obligations to the US DOE.
• Project managed compliant to remedial design for CERCLA/RCRA sites, DOE and EPA operations.
• Designed experiments (DOE) and applied statistical analyses for root cause investigations.

• Led cross-functional team for process improvements using statistical and DOE tools.
• Developed and improve process using DOE, transferred technology to CMO.
• Reviewed proposals for DHS and DOE SBIR and Office of Science.
• Trained on CDMS, EE, ICE280, ICE3, PA800 plus, DOE, Caliper, SEC and IEX.
• Elaborated novel water-free improved formulations, and employed DOE and simulations to increase nanosized film conductivity by an order of magnitude.

• Researched applications of differential game theory to anti-submarine warfare utilizing both torpedoes and anti-submarine rockets.
• Developed and taught training courses in statistical analysis, DOE and quality tools courses leading to accelerated product development timelines.
• Coordinated modeling efforts with area WFOs, Universities, and DOE laboratory.
• Utilized Six Sigma methodologies to conduct and analyze DOEs to increase project efficiency.
• Collaborated with polymer scientists to develop and execute DOEs leading to design of a novel patentable peptide formulation for coating stents.

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low Demand

• Provided technical contributions, operations leadership and knowledge of drug discovery to deliver novel drug candidates for clinical development.
• Helped company evaluate potential new drug candidates for company s pipeline development.
• 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.
• Experience in lead optimization of anti-viral (Hepatitis-c) drug candidates, antibacterial agents and KV-7 channel activators.

• Use machine learning algorithm and virtual chemical library to model molecular interactions and find new drug candidates.
• Synthesized fifty new drug candidates in one year, with an average of five steps per synthesis.
• 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.
• Design, synthesis and purification of potential drug candidates.

• Performed salt screening for new drug candidates.
• Design and synthesize small molecule drug candidates.
• Performed analytical testing, stability evaluation and data trending on late phase solid-dosage and inhaled drug candidates.
• Executed and analyzed data and determined ability of drug candidates to suppress and prevent new vascularization of the eye.
• Use biological data to define target SAR and assist in the pharmacological and pharmacokinetic evaluation of drug candidates.

• Performed multi-step syntheses of drug candidates and intermediates in 5 mg to 500 g scales.
• Supervised and mentored 1 employee in analysis of protein drug candidates via mass spectrometry.
• Analyzed and identified protein drug candidates via Peptide Mass Mapping using MALDI-MS and LC/MS/MS.
• Designed and performed preclinical pharmacokinetic studies of novel drug candidates in the rat, dog and monkey.
• Studied polyamines, naphthoquinones, porphyrins as potential anticancer drug candidates.

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low Demand

• Participated in various cross functional project teams to provide CMC expertise in regulatory strategy and post approval submissions.
• Developed global regulatory filing strategy for post approval CMC changes.
• 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.
• Prepared responses to Health Authority CMC queries and responded to CMC related medical inquiries.

• Played a key role in assisting the regulatory group in addressing CMC deficiencies.
• Transferred responsibilities to a new CMC leader for GMP clinical batch manufacturing.
• Maintained CMC product knowledge of several products in various therapeutic areas.
• Develop batch records and CMC data packages for regulatory submissions.
• Collaborated with CMC leader on authoring the compounding records.

• Tracked and managed closure of CMC regulatory commitments.
• Prepared CMC variations and supplements for global filing.
• Help write IND CMC and pharmacology sections.
• Prepared written reports for each development project; Assisted in authoring the CMC section for two INDs.
• Authored Analytical CMC sections for Abbreviated New Drug Application (ANDA).

• Contributed to CMC section of IND filing for the polypeptides.
• Developed regulatory CMC data for FDA submissions (betamethasone).
• Reviewed the CMC section of Entecavir NDA application.
• Generated and isolated forced degradation products for structural elucidation for CMC section of NDA Provided analytical chemistry support for NCE development
• Contributed to draft CMC documents for FDA pre-IND filings and quality-related protocols and SOPs.

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low Demand

• Secured a $100K Phase I small business innovation research (SBIR) grant from USDA to support this research.
• Developed sensor resource management challenge problems for the Missile Defense Agency's Small Business Innovative Research (SBIR) program.
• Establish connections with toll-service companies to scale new technologies to pilot level and commercial production for clients or SBIR projects.
• 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).

• Apply proposed technology for funding (SBIR program, Federal and State sources).
• Served as PI in DOD SBIR project AF 112-017 Curved Sensor for Vision Systems.
• 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.
• Secured a SBIR Phase I grant based on the screen results.

• Prepared and submitted Small Business Innovation Research (SBIR) proposals.
• Grant writing (SBIR), Research-projects collaboration efforts, etc.
• Develop and submit project proposals based on SBIR solicitations.
• Authored successful NIH SBIR proposals.
• Authored/awarded Phase 1 SBIR grant.

• Funded by a $500K NSF SBIR Phase II grant.
• Developed a SBIR grant proposal on Phosphorylation degree monitoring system for MEK1 in clinical samples.
• Managed additional SBIR and IR&D programs totaling $1.6 million.
• Generated company's first recombinant products and IP - Awarded SBIR grant.
• Write and implement SOPs, grant writing SBIR PII (Granted $3M), R21 etc., -Presentation-within group/CRO/CMOs.

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low Demand

• Completed equipment and data investigations when necessary to ensure the accuracy and dependability of the data produced.
• 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.
• Lead and conduct necessary experimentation to support client legal projects.

• Translated all documents necessary for final recommendations.
• Utilized 2D-QSAR in the formulation of a multiple descriptor equation (multiple linear regression) that described and predicted biological activity.
• Collaborate with Operations and QA to solve customer/product issues as necessary and avoid disruptions to the Supply Chain.
• Design studies, define/redefine goals of research, and work with customers/marketing in collecting necessary data.
• Improved 100-fold potency for one series within three months through SAR explorations.

• Design of novel targets using SAR, ADMET and molecular modeling.
• Implemented new capabilities for SAR and hyper spectral MASINT.
• Conduct SAR studies to optimize ADMET properties.
• Supported HCV, FXR, PPAR pan, CCR5, and SARM project work
• Designed and validated proteomics assay reagents with generation of all applicable documentation necessary for development of the kits.

• Analyzed and reported population PK and PK/PD data as necessary to describe pharmacokinetics in patient population.
• Developed an innovative method to assess confidence in continuous endpoint predictions for in-silico QSAR models.
• Developed a clinically relevant comparative model, for canine cancer including Osteosarcoma.
• Designed and synthesized thienopyrimidine compounds to explore SAR and improve compound potency.
• Improved electrochemical reagent systems, electrodes and related materials necessary for production.

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low Demand

• Conduct fire behavior predictions, spatial modeling, GIS tool development, database management, QA / QC and technology transfer.
• Authored the QA release SOP utilized by Pfizer Michigan Pharmaceutical Science for the review and disposition of packaging batch records.
• Process Management- Worked with a cross functional team in a project to standardize processes and documentation across QA Laboratories.
• Coordinated the efforts of Research Associates from initial procurement of materials to final QA approval and product release.
• Support QA Supervisor to supervise and coordinate tasks and activities of personnel at the laboratory area.

• Cross functional roles in QA/QC, regulatory affairs, and clean-room sterility assurance for vaccine processing.
• Team members were making undocumented improvements that skewed the QA reject rate.
• Collaborated with QA, QC, Regulatory Affairs and Medical Affairs.
• Assisted QC/QA Specialists in routine lab work & batch release.
• Resulted in no internal audit findings through QA.

• Led training to QA associates in complaint Analysis.
• Support the generation of all associated requirements and documentation, and CM, QA, and C&A efforts.
• Tasked with critical QA review of SOPs, CofA's and validation protocols to ensure compliance with regulatory standards.
• Developed Analytical procedures using, Managed QA programs included Stability Studies, Customer Complaints, Adverse Events, etc.
• Contributed to R&D, QA and QC by planning, writing and delivering agreed submission deliverables

• Created Change Controls (CCRs) and implemented changes to LIMS and ICMS upon approval from QA.
• Managed the small scale production of the biopharmaceutical product, including QA and QC processes.
• Established liaison between QA laboratory investigation and CAPA system with Cordis worldwide CAPA system.
• Coordinated with regulatory, QA, analytics and CRO to finalize study reports.
• Peer reviewed analytical data prior to submission to QA for releasing.

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low Demand

• Apply the state-of-art multidimensional protein NMR technology to determine protein/compound complexes.
• Demonstrated teamwork by training research scientists across teams in instruments including HPLC, NMR, and microwave reactors.
• Served as NMR and MS Subject Matter Expert, and Lead person for stability and compatibility projects.
• Used GC/MS, UV, and NMR to separate and identify individual components of chemical mixtures.
• Maintain the NMR instruments and automation system and control budget for the NMR instrument.

• Mentor and provide scientific guidance on a postdoc to push the boundary of NMR.
• Design novel NMR pulse sequences to improve sensitivity and reduce time and cost.
• Analyzed products and monitored reactions using NMR, HPLC, GC and LC/MS.
• 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.
• Fragment-based drug design using NMR technology.
• Worked with internal computational chemists to design and optimize a fragment screening library suitable for both SPR and NMR screening.
• Implemented a FRET/SPR screening -> NMR-> X-ray cascade to generate protein/ compound structures to guide chemistry design.
• Elucidated structures of novel bioactive natural products using IR, 1D NMR, 2D NMR and mass spectral data.

• Purified (Isco CombiFlash) and characterized (1H-NMR, MS) intermediate and target compounds.
• Developed new method for analysis of methoxysuccinyltetrapeptide by HPLC, NMR, GC/MS.
• Screen compound library by either ligand-observed NMR (e.g.
• Interpreted data of MSn, NMR, IR, X-ray EDS, Orbitrap, TOF, etc.
• Implemented structural research: keto-enol, conformational equilibriums and hydrogen bonding using NMR, IR and X-ray methods.

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low Demand

• Designed and performed molecular and cell biology experiments to investigate insulin signaling, insulin resistance, and carbon flux.
• Designed and performed cellular biochemical assays to elucidate kinetics of hits on targeted biology pathways.
• Supervised and trained intern/team members in surgery, pathology and molecular biology.
• Participated on several project management committees as the group cell biology representative.
• Provide cell/molecular biology support for the department.

• Contributed to investigative cellular biology research supported by the Uniformed Services University of the Health Sciences (USU).
• Hired and provided training for new employees in immunology, biology and lab safety.
• Guided research assistants and interns in molecular biology and vaccine development and trouble shooting.
• Collaborate with computational, PK/PD and biology teams in an integrated drug discovery program.
• Coordinated activities of protein chemistry, fermentation, and cell biology groups.

• Established methodology and trained the entire biology team in these techniques.
• Collaborate with academic scientists to advance CRAC channel biology research.
• Contributed in biology hypothesis generation and validation, tested different combination studies in vitro.
• Facilitated molecular biology techniques-DNA/RNA isolation, PCR, RT-PCR, gel electrophoresis.
• Mentored junior research associates in molecular and cellular biology and viral transduction.

• Compiled and analyzed data to establish translational strategy with biology hypothesis.
• Developed assays by using molecular biology and cell biology techniques for potency and modes of action and biomarker and pathway discoveries.
• Selected the right biology and the right model systems for the right targeted therapeutic with companion biomarkers where appropriate.
• Lead scientist for computational biology/bioinformatics in R&D department.
• Group Leader, Biochemistry and Cell Biology Developed liposome formulations for Immther, helped with GMP synthesis and manufacturing of DTP.

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low Demand

• Team successfully identified an internally developed tau antibody that passed criteria for progression to clinical development.
• Served on Quality Assurance team responsible for laboratory equipment management and internal audits.
• Reported and presented scientific and technical results internally.
• Establish external credibility via co- publications and presentations.
• Established substantive ties and collaborations with other government agencies, Intelligence community (IC) partners and relevant external partners.

• Developed high-density seed culture production in alternative media to lower the process cost.
• Created the HANDS White Paper as a comprehensive governance document for all deployments.
• Established contacts with an external experts and invited some to GSK for seminars.
• Participate in ASMS conference and published articles in peer s scientific journals
• Developed and maintained collaborations (both internal and external).

• Published results as research articles in peer-reviewed journals.
• Perform statistics instruction for internal staff.
• Maintained a productive relationship through an effective communications with internal and external stakeholders.
• Evaluated remedial alternatives and assisted in preparation of remedial investigation reports.
• Developed novel assays to detect and visualize specific mRNA species in live cells, with applications for cancer diagnostics and therapy.

• Selected, procured and installed equipment (furnaces, ovens, sorption analyzer, fume hoods, etc.).
• Created stable cell lines capable of expressing RNA-labeling probes for detecting a specific RNA in vivo.
• Reviewed batch records, SOPs, and other documents for compliance with US/international regulations.
• Control of plant viruses by RNA interference (RNAi).
• Ensured the compliance with external guidelines (SOPs, GxP, HSE, VICH).

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low Demand

• Communicate frequently with individuals within chemistry, inflammation biology, PK/PD and formulations groups to deliver next-round compounds with improved properties.
• Design and execution of PK/PD study and data modeling to derive PK/PD driver & target for prediction of clinical trial dose.
• 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.
• Established 23 PK assays which defined PK/PD relationships and allowed human dose prediction for an IND submission.

• Planned, implemented, interpreted and reported assigned Phase I to Phase III PK and PK/PD studies.
• Afforded research team the opportunity to be on schedule for PK/PD and toxicology studies.
• Managed compound shipments to biologists, PK/PD scientists in Texas and collaborators at BMS.
• Explored the relationship between PK/PD parameters of MorAb-004.
• 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.
• 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.
• Oversee PK/PD, efficacy, model development, biomarker identification, and drug combinations.

• Demonstrated differential PK/PD correlations of native and pegylated growth hormone in the knee joint.
• Evaluate PK/PD of drug candidates of small molecules and biologics via various routes.
• Apply NMR to understand target enzymology, MOI and PK/PD studies.
• Coordinated and supervised PK/PD and efficacy xenograft studies at CROs.
• Supported in vivo HCC target validation: orthotopic mouse model development, PK/PD and signal transduction pathways.

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low Demand

• Played pivotal role in cross-disciplinary study for developing novel method in validating imaging results using finite element analysis.
• Assisted multiple DoD agencies by providing expert technical evaluation and review of proposed research and development projects.
• Demonstrated ability to build and manage cross-functional collaborative relationships to accomplish project goals.
• Represented company in research consortium for building a pipeline of new value-added products.
• Cultivated strategic relationship with KOL to further research on the effect of High Energy Violet Light (HEVL) on retina.

• Participate in R&D activities to support the assessment of new and existing medical device products.
• Investigated virus growth kinetics of multiple strains in a variety of vaccine production cell lines.
• Participate and support Critical Systems validation and special projects, and prepare reports.
• Gather resources and cross- function with multidisciplinary groups to allocate project work.
• Provide leadership, supervision, and training to R&D personnel.

• Design new products, processes, and equipment for thin film deposition.
• Please see job description for Dynamics Research Corporate 2009-2011 below.
• Provided project leadership in gene discovery and protein expression field.
• Served as the senior biological science advisor in support of a complex multidisciplinary intelligence program.
• Improved accuracy for WiFi positioning by identifying, modeling and combining multiple error sources.

• Provided leadership and monitored development of products making cost / performance tradeoffs.
• Perform analytical testing and report data, equipment calibrations and reagent standardization.
• Participated in planning of pre-clinical testing requirements for Phase III and 510K submission of O2Optix Custom contact lenses.
• Featured efforts Spearheaded the alignment of the Elemental laboratory with 6-S principles.
• Coordinated and led pilot study to outsource AMP Kinase project to Caliper Discovery Alliances and Services (CDAS).

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low Demand

• 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.
• 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.

• 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.
• 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.
• Develop SEND (surface-enhanced for neat desorption) laser mass spectrometry.
• Set up and maintained liquid chromatography mass spectrometry instrument for the Primary Pharmacology Group, provided proteomic support to multiple programs.
• Identified epitopes presented at the cell surface by MHC using immunoprecipitation and mass spectrometry.

• Led ad hoc group to develop workflow for mass spectrometry data on CuraGen's web server.
• Created a web-based MS Lab application in Javascript to simulate the mass spectrometry characterization of heterogeneously modified glycoprotein with disulfide bonds.
• Mentored and Trained Scientists at Protea o Developed training documents for employees new to mass spectrometry and liquid chromatography.
• Use mass spectrometry and co-immunoprecipitation to analyze protein protein interactions, western blot, qRT-PCR.
• Involved in mass spectrometry based characterization of protein post-translational modifications (glycosylation, oxidation, deamidation peptide mapping etc.

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low Demand

• Drafted grant proposals, and acted as a principal Investigator (PI) of an over two-million NIH sponsored project.
• Secured NIH funding, pharmaceutical contracts, and deep pocket community leader support, leveraging close ties to the community.
• Completed research project specified in the PI's NIH grant, and advanced it to a new level.
• Helped in grant writing with one of the grants awarded an NIH Phase 1 funding.
• Project manager on the NIH SBIR grant # 1R43DK085754-01 entitled -Outpatient treatment for portal hypertension-.

• Awarded; National Center for Complementary and Integrative Health Grant (NCCIH/NCCAM), NIH.
• 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.
• Developed strong scientific rationale and technical plan for new NIH SBIR grant application.
• Co-investigated two NIH funded SBIR grants and one DARPA funded project.

• Research support: NIH RO1 and American Heart Association.
• Led 1.5 million dollars NIH research grant.
• 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.

• Provide DMPK support to NIH Blueprint Neurotherapeutics collaborators.
• Assisted the center in obtaining grants/contracts from NIH, DTRA, DARPA, Bill & Melinda Gates Foundation.
• Participated in writing and submitting several phase I and II NIH and NSF grants.
• Submitted proposal on S-Ketamine to NIH.
• Authored bid proposals for $75M in new contracts for pharma, NIH, NCATS, DETRA, NCI.

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low Demand

• Organized clinical studies to test efficacy of antibacterial soap.
• Identified several small molecule contributors to both signal decay and false-positive signaling in clinical studies of on-eye real time glucose sensing.
• Test and maintain drug substance and drug product stability programs for use in early stage submissions, toxicological or clinical studies.
• Designed/operated clinical studies to support claims for new product launch.
• Involved in the strategic planning and execution of clinical studies.

• Conducted clinical studies, and planned and implemented experiments.
• Conducted pre-clinical studies on cancer imaging/therapeutic compounds for diagnosis and treatment of cervical and ovarian cancers.
• Coordinate biopsy and clinical studies to support technical claims substantiation and communication.
• Optimized chemistry and scaled-up for preclinical studies.
• Research includes basic science, clinical studies in healthcare settings, and field research in community clinics and homeless shelters.

• Manage the protein expression & scale-up lab to produce 100s mg to 10s gram material for preclinical studies.
• Developed clinical pharmacokinetic assay reagents that are currently being used in MM-151 phase I clinical studies.
• Lead the endocrine research in the clinical and pre-clinical studies (local and global).
• Worked within cGLP guidelines developing vaccines for clinical studies.
• Spearheaded over 80 preclinical studies in CRO.

• Execute bio-analytical analysis for all phases of new drug development including preclinical and clinical studies.
• Conducted R&D formulation initiatives for efficacy and pharmacokinetic/toxicology preclinical studies.
• Developed and validated bio-analytical methods in supporting preclinical and clinical studies.
• Published results of preclinical studies in peer-review journals (Diabetes, Diabetologia, etc.)
• Design, synthesis and pre-clinical studies of new antiviral and anticancer prodrugs.

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low Demand

• Established the product concept and success criteria for a UV/HEVL filter system to be used in a contact lens.
• Developed ultraviolet (UV) curable coatings to protect fiber optic cables.
• Identified the negative impact of UV and ozone on conductivity of HIL.
• Identified UV stabilizers that did not react with the formulation catalyst package.
• Implemented the UV curing systems.

• Key contributions to the discovery and investigation of new molecular targets for programs in diabetes and vaccine adjuvant development.
• 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.
• Used HPLC with UV spectrophotometer to separate and identify individual carbohydrates in carbohydrate mixtures.
• Participated in computer system validation for UV/Vis.

• Developed diagnostic to temporally, spatially, and spectrally resolve PDP cell discharge from VUV-NIR.
• Created juvenile studies to be collected on TFR/Tox which automated data collection and reporting.
• Generated UV-curable coatings based on low, free-monomer urethane prepolymers, achieving U.S. patent.
• Established business need for on-press developable UV-sensitive printing plate R&D program.
• Monitored TOX TG solution stability by Uv-vis spectroscopy and functional device testing.

• Designed and developed UV cure hydrogels coating and adhesive meeting product performance requirements by optimizing coating formulations for eyegate device.
• Evaluated effects of UV radiation on GOX activity in association with hydrogel curing process for Google Glucose-Sensing Contact Lens.
• Coordinated development work with printhead partner for implementing UV IJ on the flexo press.
• Identified novel biologically active cyclodepsipeptides (Beauvericin and Chlamydocin analogs).
• Established, validated and executed primary and secondary assays for proteases that led to diabetes drug Januvia .

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low Demand

• 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.
• Supervised testing of in-process, finished product and stability samples of ANDA submission batches.
• Performed testing for development, release, and stability samples.
• Performed testing of stability samples in the Phase III stages.

• Identified unknown peaks from stability samples.
• Maintained stability chambers and provided scheduled stability samples for analytical testing to ensure completion as per due dates.
• Generate, update and approve accurate scientific data for new product development, informal stability, and pre-market stability samples.
• Analyzed R&D analytical stability samples, clinical samples and product development samples.

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low Demand

• Manage project execution and provide critical insights to advance technology readiness level in a multidisciplinary team.
• Proposed/developed cellular assay strategies, identified/validated reagents, and optimized assay kinetics suitable for HTS.
• Used consumer insights to identify strategic research and new product development.
• Provided innovative characterizations leading to useful insights to designs.
• Provide scientific insights as needed for generating a streamlined process control that maintained product quality in a large scale production.

• Established Design Insights program with consumers; led quarterly focus groups to conduct consumer product testing for new packaging concepts.
• Involved in development of primary assay and the counter screen assay for HTS, secondary and selectivity assays.
• Coordinated the purification of HTS hits both within the project team and the in-house purification group.
• Used High Throughput Screening (HTS) to identify hits & discover novel lead compounds.
• Collaborate with Marketing, Technology Insights and Product Development partners to test and launch products.

• Applied multivariate computational techniques to the evaluation of HTS data from cell-based assays.
• Applied consumer insights and research techniques to create product key quality attributes.
• Led production and coordination of samples for consumer insights HUT test.
• Developed reporter cell lines and assays suitable for HTS screens.
• Established HTS and acquired several robots to support HTS

• Developed simulation that controlled navigation of UAVs in flights and engagements over digital military maps.
• Provided technical support for the installation and startup of UHT / HTST cold fill aseptic PET packaging lines.
• Developed system performance models for displays and LED backlights.
• Key Highlights: Led a high priority research project assigned directly by Amgen head of R&D.
• Initial leads were obtained from a cell-based HTS program that identified certain guanidines and tetrahydro- quinolinones as the key scaffolds.

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