Manager, Analytical Sciences; Over 15 years in Bioanalytical Sciences
Resume:
UNITA L. PERI-OKONNY, Ph.D.
Monmouth Junction, NJ 08852 cfqpe3@r.postjobfree.com
SUMMARY
• Doctorate in Chemistry with consistent, upward growth and extensive experience in drug development working with both biologics & small molecules.
• Professional expertise centers on coordination and great interpersonal skills required to bring a drug from research to market.
• Hands on experience in CMC (analytical methods development, validation, protein and monoclonal antibody purification and cGMP compliance).
• Experience writing, reviewing and approval of SOPs, test methods validation protocols and validation reports in a timely manner.
• Experienced in isolation and purification of monoclonal antibodies from antisera.
• Reviewed and authored analytical sections as needed in Govt. proposals and CMC sections.
• Responsible for identifying and outsourcing fully developed and validated analytical methods to qualified CROs
• Proficiently trained in GLPs, GCPs, SOPs, ICH, ISO 13485:2003, and FDA regulations.
• Experience in project management, regulatory affairs and submissions (IND, NDA and BLA).
• Developed and validated bioassays using cell-based assays, cell fractions, immunoassay and ELISA assays.
• Established in-house state-of-the-art analytical laboratories and expertise in CMC and DMPK.
• Charaterized glycoproteins using a series of techniques including Plasma Protein Digestion, Strong Cation Exchange (SCX), Peptide Fractionation, Reversed-phase LC-MS/MS Analyses using ThermoFinnigan SEQUEST Algorithm.
• Developed analytical methods to monitor N- and C-terminal, oxidation, and other modifications of recombinant proteins using MALDI-TOF MS for the identification of oxidation sites and disulfide bonds of peptides and intact proteins.
• Characterized recombinant EPO (glycoprotein) and modified with polyethylene glycol (PEG) to extend its in vivo circulating time and draw correlation with the extent of PEGylation of the molecule.
PROFESSIONAL EXPERIENCE
PHARMATHENE
Manager 1/ 2011 – Present
Analytical Sciences, Annapolis, Maryland
• Provide technical leadership for analytical programs
• Develop strong partnership with contract laboratory service providers for efficient and quality programs in analytical methods development and validation
• Ensure that analytical methods are suitable for their intended purposes and meet the regulatory standards
• Review and approve as needed analytical methods, protocols and reports in a timely fashion
• Trouble shoot and provide guidance to contract laboratories and internal teams
• Expert knowledge of analytical and biophysical protein characterization tools including HPLC, CE, SEC-HPLC, IEF, SDS-PAGE, AUC, FTIR, Fluorescence, DSC, CD etc.
• Review and author analytical sections as needed in Govt. proposals and CMC sections
• Keep current with technical and regulatory knowledge
• Assist in developing in-house lab and expertise in Analytical Sciences
• Accountable for timely methods development and validation activities in support of multiple drug/vaccine development programs.
CONSUMER PRODUCTS WORLD WIDE, A JOHNSON AND JOHNSON COMPANY
Consultant 7/ 2009 – 11/2010
• Develop LC/UV, LC/MS methods and other analytical techniques used for the support of early-stage R&D platform activities.
• Recording data and maintaining accurate records of the experiments, and conducting experiments in full compliance of SOP/work practices and guidance
• Evaluate and asses new and existing technologies for the determination and characterization of triglycerides, flavors, fatty acids and natural products in new formulations.
• Manage and assist in analytical testing of products, raw materials and components in conformance with FDA cGMP/QSR, ICH and ISO 13485.
• Extensively involved in reviewing the SOPs, protocols, technical reports, technology transfer and regulatory documents.
• Manage the development of new analytical test methods and their validation, the documentation related to Quality activities, and interaction with outside laboratories.
• Develop methods, techniques and evaluation criteria for all raw materials, components, in-process intermediates, and finished products.
• Interact and coordinate activities with other departments including external vendors and customers.
• Participate in the testing and data review of all raw materials, components, in-process intermediates and finished products ensuring accurate, reliable data and timely reporting.
• Transferred analytical technology to contract manufacturers and set up specifications for drug substance and drug products.
• Experienced in providing technical leadership in analytical programs.
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY
Staff Scientist 2005-2008
Analytical Technologies, Warren, New Jersey
• Manage and maintain a safe and compliant work area in accordance with safety standards and cGMP regulations.
• Manage a staff to conduct stability studies and reporting/ communicating results, while working closely with QC testing laboratories.
• Designing and Conducting laboratory studies for characterizing biotransformation pathways of new chemical entities
• Analyzing and interpreting experimental data, review data on ongoing basis and authoring study reports and memos
• Participated in the introduction of new technologies within the analytical technologies department.
• Oversee method transfers from Analytical Technologies laboratory to QC labs and other CROs.
• Participate in managing laboratory resources to support Quality Control operations including equipment, processes, and supplies, maintenance and calibration.
• Prepare Validation Protocols (IQ/OQ/PQ) in compliance with GLP, cGMP, and ISO 13485 for approval by the Director of QS.
• System Owner and Coordinator for the Agilent 1200 series Open Access LC/MS instrument
JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT
Scientist 2000-2005
Bioanalytical, Drug Metabolism Division, Raritan, New Jersey
• Characterization of glycoprotein using a series of techniques including Plasma Protein Digestion, Strong Cation Exchange (SCX), Peptide Fractionation, Reversed-phase LC-MS/MS Analyses using ThermoFinnigan SEQUEST Algorithm.
• Hands on experience in Analytical methods development, qualification and validation, structural elucidation of impurities and degradation products using chromatographic separations (detectors; diode array, fluorescence, light scattering, electrochemical and RAD) and mass spectrometry (Sciex API 3000™, Micromass Q-Tof™, and Thermo DECA-XP Ion Trap) following strict cGLP and cGMP compliance.
• Characterized recombinant rHu-EPO modified with polyethylene glycol (PEG) and correlates its in-vivo concentration with the extent of PEGylation of the molecule.
• Compiled and interpreted bioanalytical data and authored and reviewed protocols and reports.
• Monitored bioanalytical method development and validation studies placed at contract research organizations (CRO) used to support clinical and non-clinical projects.
• Separated rHu-EPO isoforms and was responsible for determining the extent of PEGylation of EPO in support of drug discovery project.
• Other projects included characterization of peptides in low abundance in complex matrices using affinity coupled to sorbents. Some of the affinity sorbents include chemical and biological ligands (e.g. antibodies, lectins and a variety of modified silica surfaces).
• Evaluated the use of Multi-Dimensional CEC/CE/MS for proteomic application is being investigated using the Thermo Finnigan Ion-Trap MS/MS instrument.
• Transferred analytical methods to contract manufacturers and set up specifications for drug substance and drug products.
• Guided a team of five (pre and post doctoral) scientists in the department.
Senior Associate Scientist 1996 – 2000
Project Coordinator/CRO Liaison, Bioanalytical Drug Metabolism Division
• Worked on rHu-EPO (recombinant), Platelet Derived Growth Factor (PDGF; recombinant), PF4 and Atosiban supporting discovery through pre-clinical and clinical phases, participated in the preparation of their BLAs.
• Responsible for developing and validating ELISA, IGEN/ECL, RIA and LC/MS/MS, which were then transferred to contract laboratories for routine analyses in support of both drug discovery and drug development.
• Separated and purified monoclonal antibodies from antisera used to develop ELISA assays.
• Coordinated the work between the DMPK for sample analysis performed at Contract Research Organization (CRO).
• Responsible for the seamless operation and writing the required reports needed to support the appropriate regulatory filings.
• Managed the majority of bioanalytical outsourcing projects at various Contract Research Organizations (CROs).
• Inspected numerous CRO facilities for GLP compliance prior to laboratory selection, placement of the study and during the conduct of GLP studies.
• Supervised the transfer of analytical methods developed in-house to CROs, including the preparation of all required technical and Quality Control documentation.
Senior Associate Scientist, Preclinical Drug Metabolism Division 1993 – 1996
• Developed and validated quantitative HPLC and LC/MS methods for the measurement of parent drug and their metabolites according to GLP guidelines.
• Designing and Conducting laboratory studies for characterizing biotransformation pathways of new chemical entities
• Separated and quantitated enantiomeric compounds using mobile phase additive techniques and pre-column derivatization techniques.
• Designed, conducted, analyzed and reported results from non-clinical pharmacokinetic (non-compartmental modeling using WinNonlin 3.1 and 4.0).
• Isolated and identified parent drug and metabolites from complex biological matrices including Liver and Skin homogenate using radio labeled parent drug.
• Analyzing and interpreting experimental data, review data on ongoing basis and authoring study reports and memos
• Conducted in vitro studies to evaluate the extent of cytochrome P-450 induction, the extent of peroxisomal proliferation and EFCOD activity in rat liver homogenate.
• Worked closely with Analytical R & D to determine structural confirmation of proposed metabolite pathway.
• Setup, maintain and fully stock two analytical laboratories. Laboratories were maintained in full compliance with GLP, FDA and JNJ EHS requirements.
Wyeth-Ayerst Research, Princeton, NJ 1988 – 1993
Senior Chemist
• Major area of responsibility included: assay of novel pharmaceuticals, their metabolites by HPLC, TLC and LSC.
• Performed HPLC methods development on several low molecular weight compounds including Rapamycin, Cyclosporin and Nogestrel. Performed enzyme hydrolysis to determine urinary metabolite conjugates such as Glucuronides and Sulfates.
• Isolated and identified metabolites in biological matrices and determined the extent of plasma protein binding of novel compounds.
• Performed enantiomer separation of novel compounds using pre-column derivatization techniques.
• Conducted drug disposition studies and in vitro studies for total Cyp-450, Aminopyrine demethylase, EROD and PROD activity.
• Performed Pharmacokinetics data analysis using Win-Nonlin, and Lagrange software.
• Worked closely with Analytical R & D to determine structural conformation and metabolic pathways of unknown metabolites.
FMC CORPORATION, PRINCETON, NJ 1986 – 1988
Research Technician
• Responsibilities included isolation and identification of metabolites from plant and animal matrices, which were dosed with low levels of radio labeled compounds, such as pesticides or herbicides.
• Analysis techniques include HPLC, GC and Combustion/Oxidation. Identified metabolites by GC/MS and NMR.
EDUCATION
Seton Hall University, South Orange, NJ
Ph.D. in Chemistry, 2001
Thesis: The effects of acid modifiers on Electrospray Ionization in LC/ESI/MS
Seton Hall University, South Orange, NJ
M.S. in Chemistry, 1997
Trenton State College, Ewing, NJ
B.S. in Chemistry,
PROFESSIONAL TRAINING
Introduction to Management Johnson & Johnson Career Management Group
Graduate Course in Statistical Analysis Rutgers University
Graduate Course in Advanced Pharmacokinetics Rutgers University
Drug Development Process (PERI) University of Arizona
Quality Assurance & Control for Biotechnology Center for Professional Advancement
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