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Director, Analytical Quality Assurance Resume

SUMMARY

  • I am formally trained chemist and data scientist with more than a decade of scientific and executive management experience in the food & beverage, pharmaceutical and biotech industries. My specialties include big data, software engineering, and analytical chemistry.

PROFESSIONAL EXPERIENCE

Confidential

Director, Analytical Quality Assurance

Responsibilities:

  • Developed and executed strategy for building Confidential R&D’s first Big Data processing and Predictive Analytics infrastructure and used the capability to identify which combination of ingredients, products, suppliers, and manufacturing locations posed the greatest risk to Confidential .
  • Architected the process by which data related to regulatory compliance was extracted from external sources (e.g. US FDA, CA Prop - 65, EFSA, Codex Alimentarius, JECFA, FEMA/IOFI, GOST etc.), processed, formatted and used internally for regulatory compliance risk analysis and automated decision support.
  • Defined the business case for implementation of new testing methods, including continuous, inline analyzers, which reduced the need for analysts while simultaneously furnishing real-time feedback that enabled process control and improved product specification conformity.

Confidential

Director, Systems Biology Technologies

Responsibilities:

  • Served as a line manager for over 50 scientists in five teams located at three global locations: Collegeville, PA, Cambridge, MA, and Dundee, Scotland. My team’s functions included RNAi Screening, Morphological Screening Using High Content Imaging, Cell/Tissue Culture, Immunoassay Development and proteomics.
  • Worked across scientific and informatics lines to develop robust workflows, established research priorities, performed technical reviews of data and processes, and mentored staff.
  • Served as a core member of the Systems Biology Research Council and as an active participant on the Biomarker Advisory Validation Committee of the Translational Medicine Scientific Review Committee.

Confidential

Senior Director, Platform Operations

Responsibilities:

  • Managed all of R&D and platform operations, which included a team of more than 25 scientists across multiple platforms including LC/MS, GC/MS, and automated sample preparation.
  • Allocated all laboratory resources to ensure that corporate objectives were met, which encompassed both commercial, R&D and diagnostic discovery and validation activities, including budgetary responsibilities.
  • Oversaw quality assurance program for all laboratory activities, which also included a dedicated continuous process improvement effort.
  • Served as a technical resource for business development opportunities.

Confidential

Enterprise Solutions Product Manager

Responsibilities:

  • Managed the development for five core enterprise products, which included writing user requirements documents and technical specifications, allocating development resources for implementation of new features and setting the priority for resolving software bugs.
  • Supported sales and business development efforts by providing domain expertise in drug discovery and development and information technology.
  • Supported marketing team by identifying new applications for the product line, explaining new features, preparing talks, posters, and writing articles.

Confidential

Principal Scientist

Responsibilities:

  • Worked as the Bioanalytical Team Leader within the Early Discovery and Technology group, whose focus was profiling drug lead candidates for liabilities related to adsorption, metabolism and distribution.
  • Automated the process of metabolite identification for metabolic liability estimation during the lead optimization/Structure-Activity Relationship (SAR) optimization stage of drug discovery.
  • Developed numerous other software programs for quality assessment, data processing, data review, and data dissemination.
  • Worked with biologists to automate the sample preparation/incubation for metabolic stability determination (human/rat microsomes/hepatocytes), permeability assessment (Caco-2, PAMPA, MDR/MDCK), and drug-drug interaction (CYP-450 inhibition).
  • Served directly on multiple projects in the oncology therapeutic area.

Confidential

Research Scientist

Responsibilities:

  • Developed custom software applications using C++ for native Windows clients and ColdFusion for web-based applications in conjunction with an Oracle database for managing/granting access to data generated with high-throughput analytical methods (hundreds of thousands of analyses per year).
  • Served on a global project team that was tasked with developing infrastructure for seamlessly exchanging analytical data among all Confidential sites worldwide.
  • Developed many LC/MS (includes MSn) methods for a variety of applications, including metabolite identification and quantification, biomarker discovery, identification of synthetic products, etc.
  • Served as a coordinator for Open-Access LC/MS systems for use by medicinal chemists.

Confidential

Research Fellow

Responsibilities:

  • Independently developed LC/MS/MS bioanalytical methods using TSQ-7000 triple quadrupole mass spectrometer for the determination of trace levels (e.g. sub pg/ml) of suspected environmental toxicants and their metabolites in biological samples of human origin for etiological determinations.
  • Implemented simplex optimization routines using Instrument Control Language (ICL) scripting for purpose of automatically tuning instrument ion lens assembly.
  • Oversaw all aspects of method development, including analyte extraction and preparation, instrumental setup/analysis, and data management and processing.
  • Used numerous technologies such as relational databases and UNIX scripting tools for managing data.
  • Primary instrumental technique was LC/MS/MS (triple-quadrupole and ion trap); Because data was used for epidemiological studies, accuracy, precision, quality control/assurance, ruggedness, and high sample - throughput were all essential method characteristics.

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