Agensys - Principal Scientist Resume Example

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Jayden Robinson
XXXX XXXXXXXX XXX
Santa Monica, CA 90404
Ph: XXXXXXXXXXXX
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Summary
PhD in Biophysics and Biochemistry with 11+ years of post-PhD experience (5+ years in academia and 6+ years in biopharma industry) in the biophysical/biochemical/biological characterization of proteins & analytical method development. Proficient in the design, development, execution, validation (ICH), and tech transfer of lot-release/stability methods, stability program, analytical control strategies, critical quality attributes/CQAs, OOT/OOS investigations, troubleshooting of assay performance, specification, structure activity relationship (SAR),  reference standard characterization, lead author of several CMC sections for the IND filing and address pre-and post-approval commitments of regulatory agencies. Serve as contributing author to BLA/MAA. 
Technical Skills
  • Analytical techniques: High performance liquid chromatography HPLC (SEC, RP, HIC, HILIC, IEX, affinity), Mass spectrometry MS (Q-TOF, LC-MS/MS, Triple Quad, MALDI-TOF), capillary electrophoresis CE ( iCIEF, CE-SDS, BioAnalyzer), Light scattering (MALLS, SEC-MALLS, DLS), Differential Scanning Calorimetry (DSC), Analytical Ultra-centrifugation (AUC), Gel electrophoresis (SDS- PAGE, Native PAGE, western-blot, 2D DIGE), Spectroscopy (UV-Vis, fluorescence/luminescence, CD, stopped- flow), DAR (drug-to-antibody) techniques (RP, UV, HIC, SEC), Biosensor/label-free methods (Biacore, Octet, ProteOn, KinExA, Sierra), ELISA/MSD/GyroLab, AF4, NanoSight NTA, Microscopy. Exposure to Raman, FTIR, ESR, NMR, lyophilization, HIAC, ITC, Victor, CytoTox, FACS
  • Biochemical/protein prep skills: Protein extraction from plant and animal tissue/purification/ lyophilization/protein quantitation/folding/unfolding/protein-modification/labeling/cross-linking/binding/proteolysis/enzyme kinetics/enzyme inhibition/ligand-binding/cell culture, protein expression, cloning, site-directed mutagenesis
  • Computer skills: Protein structure graphics (PyMol, WebLab ViewerLite, DeepView), Protein-protein docking (ClusPro, GRAMM-X),   Statistics   (Excel,   Sigmaplot,   learning DOE-StatEase & JMP),   Bibliography (EndNote), Plotting & Model fitting (Origin, Sigmaplot, Excel), Presentation (PowerPoint), Image (Adobe Photoshop, Adobe Illustrator), databases 
Experience
Principal Scientist/Group Leader, Analytical Development Oct 2012Jul 2014 Agensys/ Astellas Santa Monica, CA
  • Lead AD group (5 direct reports), responsible for AD deliverables, serve as Analytical & Formulation rep in CMC and project teams 
  • Serve as lead author of CMC sections for the IND filing and address pre-and post-approval commitments of FDA
  • Design, development, optimization, qualification, validation (ICH), tech transfer of analytical methods for lot release/stability methods for pre-clinical (GLP Tox), and clinical (Phase-I and Phase-II) of naked antibody and antibody-drug-conjugate (ADC)
  • IND characterization 
  • Analytical data synthesis for IND, GLP-Tox study, and CD filing packages 
  • Analytical control strategies, Critical Quality Attribute (CQA) assessment, specification setting/justification, tracking method/process/stability variation 
  • Analytical data synthesis for comparability characterization, and reference standard characterization
  • OOT and OOS investigations, CAPAs, and troubleshooting of methods 
  • Author/review SOP, validation protocol/report, analytical/technical protocol/report, stability protocol/report
  • Analytical data synthesis for Tox and GMP readiness/formulation assessment/manufacturability/developability 
  • Analytical support for life-cycle management/ manufacturing & in-process batch consistency/formulation screening& stability/clone selection/lead candidate profiling/candidate selection 
  • Analytical support for process and product optimization for consistency in manufacturing/safety/efficacy 
  • Lead CRO projects to include in IND filing package
  • In-depth exposure to formulation screening/stability/recon/packaging studies
  • Identify/evaluate/optimize/implement novel cutting-edge technologies to improve quality and efficiency
  • Procurement, qualification, validation (IQ/OQ), maintenance, operation of analytical equipments
  • Support QC/Formulation/PD/Manufacturing/QA/Regulatory/Clinical & Pre-clinical/Discovery 
  • Administration /goal-setting/performance management of the AD group.
Scientist-II/Group Leader, Method Development and Characterization, Mass Spectrometry Core Group Jun 2010Sep 2012 MedImmune/AstraZeneca Mountain View, CA
  • Lead Physicochemical group (3 direct reports) and Mass-specrometry core working group (4 scientists)
  • Responsible for PC and MCW deliverables
  • Biophysical/biochemical/biological characterization of vaccine candidates (70% focus on recombinant subunit/glycoprotein vaccines and 30% focus on live attenuated viral vaccines)
  • Design, development, execution, optimization, qualification, validation (ICH), tech transfer of analytical methods for preclinical (GLP Tox), clinical (Phase-1), and commercial release of vaccine products 
  • Analytical data synthesis for CD, GLP-Tox study, IND filing packages of subunit/glycoprotein vaccines 
  • HPLC lot release assay for excipient quantitation for commercial release of vaccine product FluEnz
  • Analytical control strategies, Critical Quality Attribute (CQA) assessment, specification setting/justification 
  • OOT and OOS investigations, CAPAs, and troubleshooting of methods 
  • Analytical support for process and product optimization for consistency in manufacturing/safety/efficacy
  • Lead CRO projects to include in CD filing package
  • Analytical data synthesis for developability/formulation assessment/manufacturability/Tox and GMP readiness 
  • Analytical support for life-cycle management/ manufacturing & in-process batch consistency/formulation screening& stability/clone selection/lead candidate profiling/candidate selection 
  • Author/review SOP, validation protocol/report, analytical/technical protocol/report, CD/IND/BLA/MAA
  • Procurement, qualification, validation (IQ/OQ), maintenance, operation of analytical equipments 
  • Support Commercial/QC/Formulation/PD/Manufacturing/QA/Regulatory/Clinical & Pre-clinical/Discovery
  • Identify/evaluate/optimize/implement novel cutting-edge technologies to improve quality and efficiency 
  • Built Physico-chemical group within Analytical Development
  • Built mass-spectrometry capability at Mountain View site and trained scientists 
  • Administration/goal-setting/performance management of the Physico-chemical and Mass-spec groups.
Sr. Scientist, Biosensor/Biophysics group, Mass spectrometry Project Group Apr 2008Jun 2010 Pfizer Inc South San Francisco, CA
  • Biophysical/biochemical/biological characterization of antibody and antibody-antigen, and method development 
  • Characterization for Identity, Purity, Potency, Quantity by Mass-spectrometry, Gel, CE-SDS (Agilent BioAnalyzer), HPLC, Biacore/Octet/ELISA/MSD/Victor, UV-Vis (A280)
  • High-throughput  screening  of  antibody  libraries  to  the detailed  characterization  of  lead  candidates  for binding kinetics/affinity/potency/specificity/epitope/blocking by Biacore, Octet, ProteOn, KinExA, other label-free methods
  • Comparability assessments of marketed drug product with its mutant/sequence variant drug candidate for affinity/potency/specificity/epitope/blocking
  • Development/validation of mass-spectrometric methods to detect/quantitate biomarkers & peptides in body fluids
  • Development of a high throughput and high resolution epitope binning method in Biacore (epitope screening method)
  • Development of a novel epiope binning & functional blocking method for poor affinity systems (e.g. ScFv) in Biacore
  • Mapping of 3-D conformational epitope by Biacore, site directed mutagenesis, & 3D modeling
  • Lead a cross-functional mass spectrometry project group 
Research Associate, Center for Proteomics and Mass spectrometry Jul 2004Apr 2008 Albert Einstein College of Medicine & Case Western Reserve University Cleveland, OH
  • Biophysical characterization of proteins, protein-protein complexes by LC-MS/MS, MALDI, fluorescence, gel electrophoresis, UV-Vis, DLS, Biacore/SPR, microscopy, and method development
  • Intact mass, peptide mapping, oxidation, deamidation, modification, mutation, impurity, glycan analysis 
  • Protein-protein interface mapping by hydroxyl radical surface labeling and mass spectrometry
  • Developed a method to determine the 3D structure of protein-protein complexes from MS and docking (Protein Science 2007 paper)
  • Determined the 3D structure of actin-cofilin complex (which has difficulty crystallizing) for the first time, by this new method (PNAS 2007 paper)
  • Development of MS/MS (MS2) based quantification for probing protein-protein interaction
  • Contributed to the development of quantification software for the automation of the protein footprinting method (in collaboration with fellow bioinformatist)
  • Small scale protein purification 
Post Doctoral Scholar Jan 2003Jul 2004 California Institute of Technology Pasadena, California
  •  Protein structure/conformation/dynamics/folding/unfolding/stability/ligand-binding/enzyme kinetics/protein-protein interaction/protein-solvent interaction by biophysical methods
  • Investigated the role of protein solvation in enzyme functionality, and ligand binding (CPL 2004 paper)
  • Investigated the role of protein solvation in protein folding/unfolding (PNAS 2004 paper)
  • Small scale protein purification 
Graduate Research Scholar Aug 1998Jan 2003 Tata Institute of Fundamental Research Mumbai, Maharashtra, INDIA
  •  Protein structure/conformation/dynamics/stability/functio
  • Thermodynamics of protein-protein interaction/protein folding/unfolding/ligand–binding/enzyme kinetics
  • Developed a method to determine the true thermodynamic parameters of a seemingly two-state protein unfolding process involving intermediates (JBC 2002 paper; Published within 12 days of first receipt of manuscript)
  • Investigated the pH dependence of enzyme activity and correlated to flexibility (2003 JIB paper)
  • Biophysical characterization of soybean peroxidase that showed superior activity over horseradish peroxidase in   industrial and medicine use (2002 Biochemistry paper; 2003 JIB paper)
  • Small scale protein purification 
Education
Post Doctorate: Biophysics & Biochemistry Jul 2004 California Institute of Technology Pasadena, CA www.caltech.edu
Supervisor: Prof Zewail A.H. (Nobel Laureate in Chemistry 1999)
Ph.D.: Biophysics and Biochemistry Jan 2003 Tata Institute of Fundamental Research (TIFR, Federal Govt) Mumbai, Maharashtra, INDIA, India www.tifr.res.in
Thesis Title: Spectroscopic and Kinetic Characterization of Heme proteins
Master of Science: Organic Chemistry May 1998 University of Mysore Mysore, Karnataka, INDIA www.uni-mysore.ac.in
University first rank (5 gold medals+2 cash prizes for academic excellence; covered in leading news papers/channels)
B.Sc.Ed: Physics, Chemistry, and Mathematics May 1996 Regional Institute of Education (RIE, Federal Govt) Mysore, Karnataka, INDIA www.riemysore.ac.in
First rank for chemistry subject
Publication
2011: Zeynep A. Oztug Durer*, J.K. Amisha Kamal*, Sabrina Benchaar, Mark R. Chance, and Emil Reisler. Myosin binding surface on actin probed by hydroxyl radical footprinting and site-directed labels. J. Mol.Biol. 414, 204-216 (*Zeynep and Amisha share equal authorships)
2008: J.K. Amisha Kamal. Book chapter "Computational Approaches to Examining Protein-Protein Interactions: Combining Experimental and Computational Data in the Era of Structural Genomics" (Book: Mass Spectrometry Analysis for Protein-Protein Interactions and Dynamics. M. Chance, Ed., Blackwell Publishing,)
2008: J. K. Amisha Kamal and Mark R. Chance. Modeling protein binary complexes from structural mass spectrometry data. Protein Sci. 17, 79-94
2008: J. K. Amisha Kamal and Digambar V. Behere. Kinetic stabilities of soybean and horseradish peroxidases. Biochem. Eng. 38, 110-114
2007: J. K. Amisha Kamal, Sabrina Benchaar, Keiji Takamoto, Emil Reisler, and Mark R. Chance. Three- dimensional structure of cofilin bound to monomeric actin derived by structural mass spectrometry data. Proc. Natl. Acad. Sci.USA. 104, 7910-7915
2007: Keiji Takamoto, J. K. Amisha Kamal and Mark R. Chance. Biochemical implications of a three dimensional model of monomeric actin bound to magnesium chelated ATP. Structure. 15, 39-51
2005: J. K. Amisha Kamal and Digambar V. Behere. Binding of heme to human serum albumin: steady-state fluorescence, circular dichroism, and optical difference spectroscopic studies. Ind. J.Biochem.Biophys. 42, 7-12
2004: J. K. Amisha Kamal, Liang Zhao and Ahmed H. Zewail. Ultrafast hydration dynamics in protein unfolding: Human serum albumin. Proc. Natl. Acad. Sci. USA. 101, 13411-13416
2004: J. K. Amisha Kamal, Tianbing Xia, Samir Kumar Pal, Liang Zhao and Ahmed H. Zewail. Enzyme functionality and solvation of subtilisin Carlsberg: from hours to femtoseconds. Chem.Phys.Lett. 387, 209-215
2003: J. K. Amisha Kamal and Digambar V. Behere. Activity, s
Awards

2014: Astellas Star Point recognition from Agensys Site Head for IND filing ahead of schedule

2014: Astellas Star Point Team Award from Agensys Site Head

2013: Astellas Star Point recognition from Agensys President for outstanding contribution to IND filing

2013:Astellas Star Point recognition from Agensys VP for leading successful OOS investigation ahead of IND 

2012: Lean/Six-Sigma Green-Belt Project completion (developed high-throughput Octet titer method and replaced conventional HPLC titer method)

2012:  Lean/Six-Sigma Yellow-Belt Certification for decreasing the cycle time and assay failure rate of the HPLC lot release assay developed/validated/tech transferred to QC-UK for the EU market release of vaccine product FluEnz®

2012: MedImmune Spot Award for the successful development/validation/tech transfer to QC-UK, of a brand new HPLC GMP lot release assay for commercial release of FluEnz® in EU ahead of schedule

 2011: MedImmune Directors' Award for proposing a Biacore/Octet method for diagnosing and improving the stability of vaccine

2004: PNAS paper“Ultrafast hydration dynamics in protein unfolding: Human serum albumin” is selected as the “Third Most Read Paper” for September 2004, by National Academy of Sciences USA

2002: Award from the India Govt to represent India at the Meeting of Nobel Laureates, Lindau, Germany

2000: Selected in the panel to discuss the future of TIFR with the University Grant Commission (UGC)

1998-2003: Fellowship from Department of Atomic Energy of the India Fed Govt for pursuing Ph.D

2001-2003: TIFR Alumni Association Scholarship for career development and research

1998: University First Rank (5 gold medals+2 cash prizes) in MS (M.Sc.)

1996-1998: National Merit Scholarship (NMS) from the India Fed Govt for pursuing MS (M.Sc)

1996: First rank in chemistry in BS (B.Sc.Ed)

1992-1996: Merit scholarship from the India Fed Govt for pursuing BS (B.Sc.Ed)

1990: High distinction in high school (21st rank in Kerala state) 

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School Attended
California Institute of Technology