Pre-Clinical Research & Development, Method Development, GLP and Quality Control

Analysis and Characterization of Therapeutic Proteins, Peptides, Oligonucleotides, Complex Conjugated Proteins & Antibodies, Solid Oral Dosage and Soft Gelatin Capsules; Analysis and Coating Suspensions Formulation for Taste Masking & Protection of Moisture Sensitive API’s

BASF; Application Scientist; Pharma Solutions (January 2019-Present)

Supports customers formulation challenges and analytical needs and methods development

uPLC/HPLC, Dissolution/Distek, Tablet Friability, Hardness

Solid Oral Dosage Form Development; Formulation and Analysis

Fluid Bed Granulation (Bosch), Taste Masking and Moisture Protection by Polymer Dispersion, Drug Layering, Drug Loading Evaluation

Tablet and Softgel Capsule Coating by O’HARA Pan Coater

Supports customers needs for ODT, Instant Release, Delayed Release Drug Products

Minimizing degradation products by coating solid oral dosage forms containing moisture sensitive API’s

Bio Platform Projects Consultant

Eurofins Professional Scientific Staff; Principal Scientist II; Kenilworth, NJ (August 2016-January2019)

Forced Degradation (FD); Isolation and Characterization of Impurities (ICI) & High Throughput Screening (HT) & Merck Biologics Product Development; Protein Purification and Engineering (January 2016-August 2016)

Support Antibody and Nanobody pre-clinical candidates using various platform analytical techniques

Red and Non-Red CE-SDS; UP-SEC; HP-IEX; SEC; UV; DLS

Electronic Lab Notebook (ELN) Incorporating ALCOA Principals

Size Exclusion Chromatography; UV; Multi Angle Light Scattering (SEC-MALS and 2D-LC In-Progress)

Capillary Electrophoresis Sodium Dodecyl Sulfate CE-SDS; Beckman-Coulter ProteomeLab PA 800 Plus

Protein Concentration/ Plate Reader/Softmax-Pro Thermo Scientific/ Nanodrop 2000 Spectrophotometer

Protein concentration by Amicon centrifugal filteration devices; Buffer Exchange

Rapid In-Process sample analysis by CE-SDS

FabRICATOR enzyme digesting the hinge region of IgG, to a F(ab’)2 and two Fc Fragments

Isolation, and Characterization of Impurities by IEX, Dionex MabPaC SCX-10 Column; Automatic fraction collection of charged variants with high purities (HPLC; Agilent; 1290 Infinity/Chemstation, and re-evaluation by various analytical techniques

Generation of degraded materials for methods qualification

Contribute to Technical Reports by writing the appropriate sections (ICI, or FD)

Support HT Processes by performing RP-HPLC

Contract Employee (January 2016-August 2016)

Responsibilities include lab and pilot scale downstream chromatographic and filtration-based purification processes via analytical techniques such as AEX (AKTA), u/HPLC (Agilent/Chemstation & Waters/Empower III)

Inclusion Bodies Solubilization/ Centrifugation/ Filtration (Millipore Opticap XL3,5,10) and Refold

Protein Purification by AKTA/Avant/Fractionation

IEX Chromatography (Anion Exchange; DEAE Sepharose Column Salt Gradient, Mixed Mode Chromatography; (PH Gradient)

Enzymatic Digestions; Trypsin; Carboxypeptidase, etc.

Content Assay (HPLC; Agilent; 1100, Chemstation/ POROS Column)

u/HPLC/Waters Empower III/ Shields Column/ Purity

Substitute Teacher: Math, Science, Language and other subjects (September 2014 to January 2016)

Bergen County public and private primary and middle schools

Pfizer Vaccine development; R&D; Senior Scientist (November 2012 to March 2014)

Responsible for conjugated antigenicity Immunoassays development by Rate Nephelometry using Beckman IMMAGE 800 system; Electronic Lab Notebook

Development of Conjugated Antigenicity Stability Indicating Assay in Prevnar-13 Next Generation Vaccine Optimize polysaccharide and conjugate binding to the adjuvant (AlPO4) in the same multi antigen drug product

Development of O-Acetylation Antigenicity Assay for Staphylococcus Aureus Vaccine

Using specific mAbs to determine polysaccharides O-Acetylation levels in various levels of O-Acetylated samples designed and necessary and the important in inducing antibody response

Roche, Pharmaceutical & Analytical R&D; Senior Scientist/Scientist (July 1985 to November 2012)

Interleukin-2 Molecule Characterization; Determination of scrambling within the two disulfide bond bridges.

Interferon alfa-2a by addressing USFDA manufacturing consistency and comparability concerns over the QC release of various IFN API lots; Rapid analytical response to USFDA by peptide mapping of several lots prepared in small scale versus scale up batches and identified the root cause which was due to chromatographic issues

PEG Conjugated IFN; PEGASYS (First and Second Generation) Analytical support; Peptide mapping and characterization of numerous PEG-IFN API lots prepared at different scales and correlated with the IE profile of the same batches to establish consistency specifications. Optimized API pH to minimize the loss of PEG moiety upon storage.

MIRCERA (PEG Conjugated Erythropoiesis Protein); Developed and characterized a semi-quantitative method which globally impacted the marketed product storage temperature, determination of EPO oxidation in PEG-EPO molecule in API and in final drug product; Method transfer to Basle, Switzerland, and travel to train analysts on the method. Developed a RP method for N-Hydroxy Succinimide, PEG attachment reaction by product.

SEP (Synthetic PEG Conjugated Erythropoiesis Protein, Gryphon Sciences); Adopted new methods and optimized the existing methods for MIRCERA for SEP program.

PEG-GCSF Mutein (Granulocyte Colony-Stimulating Factor Meutin in collaboration with Kyowa Hakko Kogyo); Lead analyst; IE (component fingerprinting), SEC (molecular weight isomers), RP (purity/impurities), IE/SEC (free PEG), Density at 20oC, Osmolality, Extinction Coefficient determination by quantitative AAA

siRNA Therapeutics; Oligonucleotides Analysis (Alnylam/Roche Kulmbach) Adopted and characterized the denaturing and non-denaturing anion exchange for assay and impurity determination for each RNA strand

PYY/PEG-PYY/ Y2R, Obesity Indication Peptides, PEG Conjugated; developed and characterized SEC method able to distinguish the highly active mono forms from the inactive oligo-conjugate forms.

Humanized Obesity Protein and PEG Conjugated-rhOB; Lead analyst; Developed many chromatographic methods (RP, SEC, and data coordination and data compilation)

VIP and VPAC2/COPD (Vasoactive Intestinal Peptide); Due diligence for existing methodologies, method development and optimization.

Techniques and Methodologies; Other Skills and Competencies

Focusing of key critical attribute of the molecule (oxidation, aggregation, degradation)

Reversed Phase (RP), Anion/Cation Exchange (IEX) and Size Exclusion Chromatography (SEC)

Proteolytic Digests, Peptide Mapping, Fingerprinting (Trypsin, Lys-C, Proteinase K, V8), Chemical Cleavages (CNBR, Performic Acid oxidation in cleavage of di-sulfide bond bridges)

Extinction Coefficient Determination by AAA and A280 nm

N-Terminal Sequencing (ABI Systems)

Amino Acid Analysis, Pickering Labs (Ninhydrin Reagent)

uPLC/HPLC Systems; Waters Aqcuity uPLC, Agilent 1100 HPLC, familiar with Electrospray

Familiar with Circular Dichroism (CD), Jasco System

Familiar with Dynamic Light Scattering (DLS)

Optical Rotation, Digi-Pol 781 Polarimeter

UV, Concentrations/Absorbance Profiles, Shimadzu UV/VIS Spectrophotometer

mAbs CE-SDS Analysis; Reduced and Non-Reduced Conditions

Wet Chemistry Techniques: pH, LOD, MP, Titrations, ROI, Extractions, IR, Karl Fischer

Viscosity & Titration and Osmolality, µOSMETTE, Precision System

Chromatographic Integration Systems Waters Empower III, Agilent Chemstation

Computer skills such as Microsoft Word (reports), Excel (calculations), Outlook, Power Point (presentations) and LIMS and ELN (recording results)

Familiar with Aseptic Techniques using Biosafety Hoods

Electronic Laboratory Notebook and adheres to Fundamental Elements of Data Integrity; ALCOA Principals

Daily calibration checks of balances, pH meters and other equipment.

Preparation of test solutions, reagents, reference standards.

Description of Responsibilities, Accomplishments and Impacts

Highly motivated and multi tasked analytical scientist with excellent work ethics, enthusiasm and passion for sound analytical results. Possesses interpersonal and leadership skills and exhibits sense of belonging and responsibility in achieving project goals within teams or lab personnel with strong sense of urgency to achieve results. Ability to change priorities based on business needs and timelines.

Independently innovates, optimizes, adopts, and/or develops stability indicating analytical methods used in assay and purity assessments of recombinant proteins, various sized polyethylene glycol conjugated proteins, complex macromolecules (protein conjugates in vaccines), peptides and small molecules. Contributes data and validates analytical methods according to established protocols, SOPs and validation reports. Performs laboratory research and/or routine sample analysis and forced degradation studies with minimal supervision.

Characterizes and identifies impurities and degradation products in drug substance and finished products. Supports stability and in-process development activities including analysis of starting materials, intermediates and final API. Determines possible degradation, aggregation, oxidation, and establishes batch to batch consistencies and correlates data from various analytical methodologies. Supports prototype drug products and experimental formulations.

When required, performs analysis in accordance with GLP requirements and standard operating procedures and interacts with QA/FDA auditors. Records laboratory work according to documentation guidelines. Interprets test results and reviews analytical data for completeness and correctness. Performs routine laboratory investigations and conducts investigations on aberrant results. Collects and analyzes data to draw conclusions and offers solutions and actions for OOS /OOT results.

Generates toxicology stability data necessary to support toxicology studies. Assesses stability data generated versus specification and known trends.

Provides support during pre-formulation screening and formulation development. Supports formulators in scheduling, initiation and design of meaningful stability studies. Designed short term stability studies for both large and small molecules lead compounds to determine degradation products primarily using chromatographic techniques (u/HPLC Empower III/Chem-station). Supports chemical synthesis activities by analyzing many in-process samples providing rapid results.

Performs analytical due diligence and reviews stability and characterization reports from research partners and contract research organizations. Evaluates, adopts, optimizes and transfers analytical methods from various Roche sites and licensing in companies.

Critically evaluates complex analytical results in search of meaningful data. Strong ability to troubleshoot analytical vs product problems. Ability to design sophisticated experiments with strong in data interpretation and understanding the unexpected results. Record data on Lab Information Management System (LIMS), and generates Certificate of Analysis.

Effective communication and concise in presentation of scientific data using Word and Power Point of relevant scientific conclusions to management and other departments.

Strong organizational and prioritization skills with strong analytical problem-solving abilities. Finds educated solutions to complex problems by applying well-developed state-of-the-art scientific principles, knowledge and experience to achieve objectives in R&D analytical laboratory.

Positive team player and confers with scientists and formulators on current work status by frequent Power Point presentations and correspondences on various projects and in the absence of supervisor serves as analytical team member in local and global project teams. Schedules and organizes assigned activities efficiently and able to work effectively, independently and as part of a team.

Adheres to all relevant safety guidelines and compliance requirements. Demonstrates desired company values and behaviors and performs special duties upon need.

Provides leadership and trains associates on analytical methods and instrumentation. Manages daily, laboratory activities, such as monitoring of lab equipment validation and calibration status, equipment logbooks, laboratory waste, and resolves discrepancies. Manages storage of reagents and test solutions in accordance with departmental procedures, maintains laboratories operations and documentations in accordance with GLP regulations and departmental SOP’s. Audits and inspects GXP laboratories.

Education and Other

Hebrew University of Jerusalem, Israel, B.Sc. in Chemistry; 1980-1984

Rutgers University in Newark, NJ. Non-Matriculate Graduate Courses in Biochemistry; 1989

Fluent in English, Hebrew and Farsi

US Citizen, Clean Drug Screening; Background and Driving Records; Verifiable Employment & Education

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