Pharmaceutical and Biotechnology Drug Product Development and Mass Spectrometry Expert

Expertise

• Analytical and bioanalytical methods for characterization and quantitation of drug therapeutics and pharmaceutical product development.
• Monitor analytical and bioanalytical activities at CROs in support of non-clinical and clinical trials.
• Characterization of small molecule, biologics (peptides, proteins, and antibodies), antibody drugs conjugates (ADCs), PEGylated proteins, and oligonucleotides.
• Drug Metabolism and Pharmacokinetics (DMP) parameters, basic non compartmental analysis and data interpretation.
• GLP and GMP.
• Launch LIMS data base systems, for tracking informatics data from multi-'omics' (genomics, proteomics, and metabolomics) experiments and workflows, and for automated data collection from various instruments into the LIMS system
• Immunogenicity and neutralizing antibody assay development.
• Biological assays such as ELISA (direct, sandwich, and competitive) assays.
• Organize and deploy resources in various projects and programs to assure technical, regulatory, budget, and schedule adherence.
• Develop, train and recruit diverse project teams of scientists ranging from junior research associates to Ph.D. level senior scientists and spanning multiple scientific disciplines including pre-clinical, clinical, regulatory, QA/QC, process development, and formulation.
• Quantitation and characterization of small molecule, biologics (peptides, proteins, and antibodies), antibody drugs conjugates (ADCs), PEGylated proteins, and oligonucleotides.
• Patent applications, scientific publications, technical reports, SOPs, and other documents in support of IND and BLA regulatory filings.

Experience

Undisclosed Company, Founder and Principal Consultant, Present

• Provide bioanalytical and analytical solution as the Subject Matter Expert by establishing core facilities, and supporting drug development programs from research to development, through providing leadership and oversight of in-house and external (CRO) support.

Services

• Selection of instrumentation, assist in planning, budget, purchase, and installation.
• CRO selection, qualification and management.
• Study management, protocol review.
• Project management, timelines, budgets.
• Biologics and small molecule characterization.
• On-site and remote technical support.
• Advanced method development and optimization.

Nektar Therapeutics, San Francisco, CA, 2016

Associate Director of Biologics, Analytical Development

• Direct and develop the team responsible for product characterization, analytical method. development for IND/BLA filing of Nektar Biologics (PEGylated proteins) products in preclinical and clinical development stages.
• Conceived the idea and led the team responsible for development of a novel strategy for characterization of PEGylation distribution and site of PEG attachment on PEGylated proteins. (this work is subject of a patent application).
• Optimized conjugation chemistry for isobaric tags (TMT), used in relative and absolute quantitation of proteins by LC/MS/MS.
• Oversight of analytical lab built out. Working with facilities, finance, and management team to design the lab space, instrument purchase and allocation for various functionalities.
• Regularly interact with senior management for projects updates and communication.
• Work in conjunction with functional teams to transfer and implement science/technology.
• Define practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Provide regular performance feedback, development and coaching to direct reports.
• Provide scientific and technical guidance, leadership and decision-making.
• Coach and mentor reports and junior members of the team.

ZosanoPharma, Inc., Fremont, CA, Associate Director of Bioanalytical Sciences, 2012 - 2016

• Previously as Principal Scientist, Analytical and Bioanalytical Lead: Led internal and external analytical and bioanalytical functions to support all aspects of Research and Development using micro-needle technologies to increase speed, convenience and efficiency of drug delivery.
• CreatedaLC-MS lab by reallocating resources obtained from sell of unused old and broken equipment, repairing existing unused equipment, and training personal to use the LC/MS system.
• Performed speedy analysis and interpretation of PK data for Pre-clinical and Clinical groups.
• Analyzed and reduced internal and external data, for LC/MS/MS analysis of PTH, Glucagon, and excipient (LMPC), and recommended plan of action to achieve project objectives.
• Contributed to preparation of bioanalytical sections of IND/BLA documents.
• Used JMP software to assess statistical relevance and determined data trends in clinical patch residual data.
• Identified and managed CRO and CMO alliance vendors to prepare and produce high quality deliverables on time and on budget.
• Developed and implemented RP and SEC HPLC assays in support of formulation and manufacturing teams, for Liraglutide, Semiglutide, and Glucagon.
• Created a HPLC course and successfully trained junior scientists in research and development to assist the QC department.
• Reviewed technical internal and external BA reports and SOPs to ensure GLP and GCLP compliance.
• Evaluated and successfully developed direct cell based biopotency assays for PTH and Glucagon in collaboration with DiscoverX.
• Led immunogenicity effort, for PTH and Glucagon, and developed plan for assessment of immunogenicity for PTH and Glucagon in collaboration with CROs.
• Evaluated new technologies to improve efficiency, accuracy, and sensitivity of bioanalytical assays.
• Served as in-house analytical/bioanalytical expert to introduce new technologies and instrumentations.
• Successfully led the effort to develop ELISA and LC-MS-MS assays for HGH, Glucagon, and PTH for pre-clinical and clinical studies.
• Served as a conception partner in a Business Development team to evaluate new opportunities and potential partnerships.
• Successfully developed a high performance team by careful selection and training of staff, and provided guidance on career objectives.
• Ensured seamless incorporation of new equipment and personnel as to avoid any disruption of work.

Codexis, Inc., Redwood City, CA, Senior Scientist and Proteomics Group Lead, 2008 - 2012

Staff Scientist III and Group Lead, 2010

• Led analytical and bioanalytical capabilities in support of enzyme evolution technologies to increase selectivity and potency of biocatalysts products.
• Built and led proteomics capabilities within Codex, through working with management and analytical leads across international sites, (i.e., Singapore, Hungary, and Redwood City) Providing training and justification for purchases of various instruments; LC-MS (5600), CE, and various separation technologies to isolate and characterize proteins.
• Led development of new Solid Phase Micro Extraction (SPME) GC-MS methods for analysis of small molecule fermentation byproducts.
• Led efforts to develop infrastructure and streamlined in-house mass mapping process for sample preparation, LC-MS analysis, and data processing. Compiled data from in-house and outsourced analyses into the LIMS system.
• Used high resolution mass spectrometer to perform structural elucidation of large scale fermentation impurities.
• Introduced glycoprotein characterization capabilities to better understand and develop enzymes and proteins.
• Used PCA software, MarkerView, to profile and evaluate trends observed in biological samples, in order to evaluate and assess system biology experiments.
• Successfully launched GenoLogics software, to track workflows and automated data collection from various instruments into the LIMS system, (combined information from multi-'omics' (genomics, proteomics, and metabolomics) experiments).
• Developed and optimized methods utilizing existing technologies to meet the needs of various project teams for analysis of biomass inhibitors for bio-fuel projects.
• Evaluated new analytical technologies and instrumentations such as Differential in Gel Electrophoresis (DIGE), to develop new platforms for simultaneous and side by side evaluation of samples obtained under different fermentation conditions.
• Successful development of a high performance team by careful selection and training of staff, and provided guidance on career objectives.

Amylin Pharmaceuticals, Inc., San Diego, CA, 2005 - 2008

Associate Director Bioanalytical Chemistry

• Led analytical and bioanalytical activities within research and development in support of moving Exenatide to market as safe and effective biotherapeutics, BYETTA and BYDUREON, to reduce A1c in patients with type 2 diabetes.
• Led bioanalytical in vivo and in vitro screening of new biotherapeutics within research.
• Increased productivity (successful sample analysis) by 300%, via implementing various techniques such as on-line sample cleanup, working with the IT team to automate batch processing of data, and training junior team members to reduce down time due to instrument breakdown.
• Led efforts to support metabolite identification studies for various projects.
• Developed new tools and technologies to expedite metabolism and biomarker identification.
• Provided mass spectrometry and separation expertise to Process Development team, and led development and transfer of LC/MS/MS assays to CRO for impurity identification.
• Reviewed technical internal and external analytical reports and SOPs to ensure cGMP compliance.
• Identified and managed CRO alliance vendors to prepare and produce high quality deliverables on time and on budget.
• Contributed to preparation of analytical sections of IND/BLA documents.

Genentech, Inc., San Francisco, CA, Scientist/Group LEAD, 2000 - 2005

• Led Mass spectrometry effort for analytical and bioanalytical characterization of ADCs, other antibodies and small molecule analysis.
• Created state-of-art technology infrastructure for analytical and bioanalytical assays using mass spectrometry and related tools such as, nano-separation, immunoaffinity, and statistical software for evaluation of ADCs and other antibody conjugates.
• Developed and transferred an assay to CRO for GLP quantitation of free DM1in plasma.
• Identified and managed CRO alliance vendors to prepare and produce high quality deliverables on time and on budget.
• Developed a new approach for characterization of drug loading onto antibodies for ADCs and other antibody conjugates, for Process Development team using mass spectrometry.
• Investigated in vivo and in vitro metabolite identification for ADCs.
• Developed an LC/MS assay for quantitation of Xolair in human serum in the presence of IgE.
• Developed a method for quantitation of individual ADCs in plasma using immunoaffinity separation-LC/MS (IMS), resulting a patent in US, Europe, and Canada
• Successfully developed high performance team by careful selection and training of staff, and provided guidance on career objectives.

Chiron Corporation, Emeryville, CA, Scientist II,1998 - 2000

• Managed Bio-analytical Lab and in-house pre-clinical analyses. Developed new LCMS methods for analysis of biological matrices on triple quadrupole mass spectrometers.
• Set up the Bio-analytical Lab (purchased instruments, upgraded the existing equipment, developed new methods, and trained the personnel to use the new setting effectively and efficiently).
• Supervised PhD and non-PhD colleagues.

ThermoFinnigan, San Jose, CA, Senior Application Specialist, 1996 - 1998

• Pre and post-sale support for external customers, problem solving for customer applications, presenting LC/MS/MS products including the LCQ.
• Conducting customer training, and developing new analytical methods using our ESI and APCI sources for verity of samples ranging from small molecules to peptides and proteins, oligonucleotides, and synthetic polymers .
• Laboratory management. Supervised Ph.D. colleagues. Publication and presentation of scientific papers.

UCLA Olympic Laboratory, Los Angeles, CA, 1995 - 1996

Staff Research Associate IV Senior Scientist, Dept. Pharmaceutical. UCLA School of Medicine

• Responsible for the High-Resolution Mass Spectrometry steroid testing during the Summer Olympic Games in Atlanta.
• Research of drug and steroid testing using GC/HRMS and LC/MS/MS methodology development.
• Enhanced the recovery of anabolic steroids significantly and improved levels of detection.
• Designed modifications to the SOP for the Atlanta Olympic games.

U.S. EPA - University of Cincinnati, Cincinnati, OH, 1991 - 1994

• As the Environmental Senior Research Associate heading a joint project, Environmental Research in Petroleum.
• Maintained and upgraded all instruments. Trained and supervised technicians.
• Designed experiments, reviewed proposals, conducted basic research, wrote papers and presented papers at scientific meetings.
• Developed a new methodology for quantitative profiling of petroleum hydrocarbons (as a result grant approvals increased from $250K to $1.5 million); this method is now being used by both the EPA and the Coast Guard for evaluation of oil spills and bioremediation agents.
• Reorganized and reestablished the laboratory; trained technicians and generated an effective QA/QC program.

University of California, Berkeley, CA, Postdoctoral Fellow, 1990 -1991

• Responsible for the lab safety for our group (40-hour OSHA training Class, and First Aid training).
• Taught General and Organic Chemistry. Helped graduate students with their research projects.
• Worked with air-sensitive chemistry techniques including Schleck line and glove box methods.
• Experienced in X-ray crystallography, NMR, EPR, IR, FTIR and UV-vis spectroscopy. Involved in multi-step organic and inorganic synthesis.
• Designed a new synthetic approach to reactive intermediates involved in nitrogenase enzyme chemistry, resulting in successful grant renewal and publication of five papers on that topic.

Honors & Publications

• Phi Kappa Phi Research Award
• Julian Parker III Research Award
• Phi Lambda Upsilon (National Honorary Chemical Society)
• Omicron Delta Kappa Honor Society
• Pi Mu Epsilon Math Honor Society
• The American Institute of Chemists Award to Outstanding Student Majoring in Chemistry
• Nominated for Outstanding Women Student in Chemistry Award (Awarded by Iota Sigma Pi)
• Awarded Grants-in-Aid of Research by Sigma Xi (the Scientific Research Society)
• Modeling Studies of &261, bis-para-anisyl Alkanes

Academic and Professional Affiliations

• American Association of Pharmaceutical Scientists (AAPS)
• American Society for Mass Spectrometry (ASMS)
• American Chemical Society (ACS)
• Pharmaceutical & Bioscience Society (PBSS)
• The San Francisco Bay Area Mass Spectrometry (BAMS)
• Postdoctoral Fellow at University of California, Berkeley, CA

Publications and Patents

• Author-Co-Author: Publications, peer reviewed journals, technical papers, and forensic studies.
• Domestic and International invited speaker.
• Inventor-U.S. patent

Education

• Ph.D. Inorganic Chemistry, Spectroscopic Studies-Polyoxometalates, Emory University, Atlanta, GA
• B.S. Chemistry (Cum Laude), College of Charleston, Charleston, SC