STEVEN R. FABIAN

** ********** *****, ********, ** 08005

(Residence) 609-***-**** (Mobile) 609-***-****

acur1o@r.postjobfree.com

EXPERIENCE

Amazon EWR4 (11/15- present)

Fulfillment Associate, Inbound

Bright, motivated, and possess a strong work ethic, attention to detail, the ability to meet deadlines, and a commitment to customer service. Pick customer orders on all levels of a multi-level mezzanine, pack and ship orders, and troubleshoot problems to resolution. Understand all aspects of production; and adhere to strict safety, quality, and production standards. Also experienced with VRC operations to get goods up to needed sort areas in an expeditious manner, and supply those on decant lines with empty and clean carts. Maintain work areas in 5S standards and requirements.

J-Star Research (01/15- 04/15)

Associate Scientist IV

Perform crystallization and solid state characterization analyses/studies of cyclosporine (for ophthalmic formulation) and other solid samples from process R&D, using Varian 300 & 400 MHz NMR, Rigaku MiniFlex 600 PXRD, TA Instruments Discovery DSC & TGA, Olympus PLM, Horiba LA-910 PSD, with some method development and non-routine analysis as required. Generate analysis reports in a timely manner following desired formats. Perform solid form screening and take lead on solid form studies (salt selection and polymorph screening projects). Identify and evaluate lead forms with suitable properties for formulation development. Report experimental details and results, and communicate with the client at meetings. Responsible for instrument maintenance and repair and lead all efforts to ensure all solid state characterization instruments are functioning properly at all times. Document activities related to maintenance, repair, calibration, safety, etc., especially for cGMP instruments. Support of Crystallization Process Development projects, advise and assist in equipment setup, maintenance, repair, etc. Contribute to the team by participating in design of crystallization processes of controlled and non-controlled substances or highly potent compounds.

Bristol-Myers Squibb (11/11 – 01/15)

PDT, DPST Aseptic Technologies Laboratory Supervisor

Assist scientists in the evaluation and development of excipients in formulation of new drugs in development and stability/compatibility laboratories, as well as in the pilot scale processing operations. Support purchasing and installation of new instruments and equipment, support preventative instrument maintenance, service contracts, register instruments in database, facilitates instrument relocations, trade-ins, recycling and decommissioning of HPLC, UPLC, and other common lab instruments. Laboratory assignments include the following: preparation of buffers and other media, potency and degradant analysis, dissolution analysis, physical and mechanical shake testing of finished dosage forms and intermediates. Familiar with test equipment such as: Real Time Dissipation Monitoring by QCM-D, SE-HPLC systems (H Class Acquity), Protein Simple ICE3 Isoelectric Focusing (cIEF), Spectrophotometer Drop Quant, automated UV diode array dissolutions systems, and Nanosight, HIAC Particle Counter, ARCHIMEDES & MFI liquid particle counters. Responsibilities include maintaining laboratories and equipment under GLP conditions and recording data in notebooks and computer databases. Pilot scale formulation and process development assignments include assisting 27 formulation scientists in the development of new dosage forms using process equipment such as: GPC, SDS-PAGE (reducing and non-reducing), Automated Cap DSC, Western Blot, Micro Flow Imaging (MFI), Dynamic Light Scattering, HIAC, lyophilizers, autoclaves, computer assisted data acquisition of process information, and clean up. Assist in weighing, processing and packaging of finished product and intermediates for stability studies. Processing includes unit operations such as filtering, sterile filling, lyophilization, etc. Some projects require working in clean rooms or aseptic areas and the anti-cancer containment area using established handling procedures to handle oncology and chemotherapy medicines. Highly experienced with SAP/SRM to procure equipment and supplies for all labs and operational areas.

PDT, DPST Commercial Oral Technologies Operations

Conduct characterization studies on new drug candidates to define chemical properties using different analytical tools. Develop parenteral dosage forms for clinical and commercial use, and conduct optimization and scale-up studies. Assist in the manufacture of pharmaceutical oral dosage products for use in clinical studies. Unit operations include but are not limited to weighing, mixing, granulating, milling, compression, coating, encapsulation, and fluid bed operations. Responsible for equipment setup, batch execution including completion of associated batch documentation management and equipment logs, equipment cleaning and equipment storage. Utilized machines include:

Bohle BFC5 Coater

Thomas 24-C Compulab Coater

Freund Vector LDCS Coater

Korsch PH100 tablet press

Alexanderwerk WP120 Roller Compactor

Quadro CoMil 197S

Pharmatron AutoTest 4

Mini CoMil

Diosna Hi Shear Granulator

Fielder PMA 65 High Shear Granulator

FT4 Powder Rheometer

Micromeritics AutoPore IV Porosity Tester

Maintain laboratory note book and equipment under GLP compliance. Record raw data, calculate results and report results to supervisors and database. Characterize in-process and finished dosage forms using methods such as Erweka powder flow testing, particle size testing (Horiba), powder bulk/tapped density, disintegration, dissolution, friability, hardness, mass, particle size, porosity, and thickness. Attentive and communicate any irregularities that occur during the performance of various assays. Excellent problem solving and mechanical abilities to tear down and re-assemble machinery and repair machine parts.

Department of Defense, United States Government (08/09 to 01/11)

Research Chemist

Non-classified and classified work included crystallization, solid-state characterization (PXRD, Auger (XPS), FTIR, Raman, PLM of small molecule organics and metal oxides) and organic synthesis, acid/base chemistry processes for scale-up in-house and for process design to transfer to third-party vendors. Trained and certified on detection and handling of unexploded ordnance. Performed BET Surface Area testing, process optimization, Preparative HPLC, crystallization, nanocrystallization and polymorph studies of energetics. Use SAP to purchase lab supplies. Level-1 acquisition certification achieved. SECRET security clearance granted and active.

Wyeth/Kelly Scientific (06/09 to 08/09)

Senior Analytical Chemist

Planned, organized and scheduled Global Quality Analytical Development activities with varying levels of supervision, based on the situation, in of support of new product launches, existing marketed products and other special projects. Assisted in the organization and providing of daily supervision to other analytical chemists to achieve project goals and/or activities to ensure proper management of laboratory operations. Typically worked on projects ranging in complexity and degrees of involvement with complex internal and/or external interfaces.

Developed and validated GMP analytical methods relating to the support of Quality Assurance of marketed products and products in Phase II and Phase III. Compiled validation data into comprehensive reports. Performed analytical method development and transferred analytical methods to Wyeth and third-party vendor laboratories in support of new product launches and existing marketed products. Applied creative ability and specialized scientific knowledge methods to solving marketed product analytical problems or evaluating changes to APIs and critical excipients used in marketed products. Evaluated and implemented new measurement technologies to improve sensitivity, selectivity, and/or the ability to characterize API’s, excipients, in-process materials and finished products. Generated analytical data for the purposes of determining the level of correlation to measurements that use Process Analytical Technology techniques and accounted for ensurance that the analytical measurements were accurate and that methods were in compliance with FDA, and/or other applicable regulatory agency guidelines, cGMP, and corporate requirements. Designed, developed and scaled up a novel method for the purification of a novel opioid antagonist for which worldwide patents were filed and granted.

Sepracor/Kelly Scientific (05/06 to 02/09)

Process Research Chemist

Conducted organic synthesis of pharmaceutical intermediates and drug candidates for the Chemical Process Development Group with a focus on crystallization process evaluation and reaction engineering from scale-up to kilo lab. Developed in-process assays, asymmetric synthesis methods and technologies and conducted impurity isolation. Routinely used Empower HPLC, chiral HPLC, Preparative HPLC, Waters LC-MS, Varian 300, 400 & 500 MHz NMR, Rigaku MiniFlex II PXRD, Olympus PLM, TA DSC, Horiba LA-920 PSD and TA TGA for chemical analysis. Performed crystallization and safety experiments using RC-1, Lasentec and Crystal 16 instruments. Utilized InPhotonics Raman and IC-10 React-IR for crystal form characterization and in-situ reaction characterization. Routinely conducted salt form resolutions, polymorph screens, co-crystal screens, salt form screens, chiral resolution screens and define parameters needed to crystallize novel anti-depressant candidates. Recorded all experimental results in a laboratory notebook following standard and customary SOP’s and protocols. Communication of experimental results via written reports and oral presentation at team meetings was done on a routine basis using Microsoft Office. Disposed of hazardous waste properly classified on-site. One provisional patent was filed for new crystalline forms for a compound in early development.

Johnson & Johnson/Kelly Scientific (04/05 to 10/05)

Process R&D Research Chemist

This position provided for pilot plant support up to phase I studies. Responsibilities included performing organic synthesis experiments of varying reaction scales up to 100 L in both GMP and non-GMP environment, i.e. from mg to kg, with process chemical analysis of reactions by TLC, LC-MS, GC-MS, NMR and other instrumental techniques as required. Purification of reaction products via preparative HPLC and crystallization together with complete characterization using solid-state NMR, LC-MS, 1H NMR,, 13C techniques, and DSC was done regularly. Performed crystallization experiments using Lasentec and polymorph screens to determine crystal habit and form. Recorded all experimental results in a laboratory notebook following standard and customary SOP’s and protocols. Coordinated reaction safety runs with the Reaction Safety Laboratory using RC-1 and LabMax. Communication of experimental results via written reports and oral presentation at team meetings and/or a combined group meeting was done on a routine basis using Microsoft Office.

Bristol-Myers Squibb/Aerotek (06/03 to 04/05)

Contract Pharmacist, Discovery Pharmaceutics, Pre-Clinical Optimization and Pre-formulation Research Group

Performed medium throughput solubility and log P partition coefficient screening on over 2,000 small molecule drug candidates to quickly identify potential marketable drugs. Assays were done using Waters 2690 HPLC (Millennium 4.0) and Agilent 1100 HPLC (ChemStation). Designed polymorph screens on specific projects to identify stable neat forms and used PXRD, DSC, TGA, PLM, Circular Dichroism, and hot stage microscopy for solid-state characterization. Collaborated with medicinal chemists to optimize chemotype and scale-up crystallinity studies for particular compounds identified as development candidates. Filed and was granted two patents for discovery of new crystalline forms of novel Factor Xa drugs. Supported 12 therapeutic programs at four facilities. Assisted in special projects with the High Throughput Group and Solid State Characterization Group by growing crystals for single crystal x-ray analysis and using proprietary in house software for molecular modeling.

Merck & Company, Incorporated/Merck Basic Research Laboratories (2/88 to 9/02)

Basic Research, Synthetic Services Group

Provided sub-kilo and kilo scale crystallization, organic synthesis and acid/base chemistry support for seven medicinal research teams to design synthesis, optimize processes, and scale up multi-step schemes from bench top to up to 500 liter scale in the SSO and MSO pilot plants and provide drug and drug intermediates for safety assessment candidates and structure activity relation studies.

Synthesized a mini-library for the combinatorial chemistry group.

The majority of the projects utilized large Preparative Chromatography and small-scale chiral and analytical chromatography with various polysaccharide stationary phases. Instruments such as the 500 MHz NMR, LC-MS, Berger SFC, Biotage Flex System and Varian RamPak were used with normal phase, reverse phase and chiral columns ranging in size from 4.6 mm to 150 mm. Isolated numerous compounds by crystallization for toxicity studies and analog synthesis.

Synthesized 4 enantiomers as safety assessment candidates in four therapeutic areas.

Used of ISIS/Draw, Chemdraw and HyperChem software for database maintenance and molecular modeling.

Closely worked with Varian, Hewlett Packard and Biotage to customize chiral HPLC hardware and software to program special desktop applications. Supervised and instructed junior chemists on synthesis, scale-up issues and lab safety.

Process Research, Chemical Engineering R&D

SINGULAIR

Staff Chemist applying engineering principles to design and process optimization of overall synthesis of API.

Reduced the overall organic synthesis in the lab from 13 steps to 9 steps, eliminated the synthesis of an unstable intermediate and made numerous equipment and P & ID modifications/changes to optimize pilot plant operations which were later demonstrated at the factory scale. Conducted analytical method development in conjunction with ARD and Process Chemistry Groups.

Crystallized the first pure and stable neat form of MK – 0476 (Montelukast) sodium salt and defined PSD by controlling crystallization parameters.

Identified reaction parameters of the mesylate step by studying kinetics of the mesylate and its impurities.

Provided numerous engineering calculations (heat & material balance) and chemical modifications to crystallize the monoaldehyde, ketoester, hydroxyester, diol, sodium salt, mesylate and side chain intermediates in the MK - 0476 process to facilitate GMP pilot plant scale-up. Operate GC-MS, GC-FID and GC-TID in addition to HPLC for pilot plant support.

Provided technical, scientific and problem solving support for various teams of engineers in a flexible and cooperative manner to ensure timely and smooth operations in the Unit Operations Lab and GMP Small-Scale and Large-Scale Organics Pilot Plants to provide pure final product that was made to supply clinical trials with pure drug.

VERLUKAST

Developed an efficient and effective lipase recovery process for the enzymatic hydrolysis step and crystallization of a MK-679 (Verlukast) intermediate.

IMIPENEM

Optimized the crystallization of ADC 12/13 intermediates in the new Imipenem factory process.

MEVACOR

Optimized the whole broth extraction step using a Podbielniak liquid-liquid extractor and filtration equipment to remove cell debris.

IBUPROFEN

Assisted in design and development of a continuous crystallization of the resolution of Ibuprofen via stereospecific crystallization in the Unit Operations Lab (UOPs).

ZOCOR

Designed and optimized the penultimate step to produce pure crystalline material for a final particle size range of 100-200 micron.

Engelhard Corporation (05/84 to 02/88)

Technical Service Chemist position in Minerals & Chemicals Group. Investigate current and novel uses of surface treated kaolin, silica and attapulgite mineral fillers to modify properties of polymers, coil coatings and elastomers. Duties included operation of heavy machinery equipment such as muffle furnace, 50 ton press, single and twin screw injection molding machine, various powder mills and mixers, two roll mill. Laboratory investigative work involved using a melt rheometer and Instron test equipment to measure tensile strength and flex modulus properties according to ASTM test procedures. Also ran CHN analysis and prepared samples for SEM.

EDUCATION

Bachelors of Applied Chemistry, New Jersey Institute of Technology with a GPA of 3.20.

Conducted research under Dr. Howard Perlmutter to investigate the novel synthesis of quinolones with Tacrine as the target molecule. Familiar with AutoCAD, Symyx and SyBiL software for molecular modeling desktop applications in addition to FORTRAN and C language computer programming.

Attending Stevens Institute of Technology to obtain a Master’s Degree in Material Science Engineering.

Participating in on-line classes with UC Davis to obtain certification as a Winemaker.

AFFILIATIONS

Bristol-Myers Squibb Crystal Engineering and Co-processing CoP Group

Bristol-Myers Squibb Solid State Characterization CoP Group

Bristol-Myers Squibb Mini-Piloting CoP Group

Member, American Chemical Society

Associate Member, Society of Wine Educators

CERTIFICATIONS

Teacher of Chemistry in New Jersey

Master Sommelier Introductory Sommelier Course

Rigaku Certified on MiniFlex II

Waters Acquity UPLC

Spanish Wine Educator

Level I Certified Defense Acquisition University

TRADOC Honorary Cannoneer

ANM-R-350-4, DAP 385-64 and OSHA CFR-29 Ammunition and Explosives Certification

TWIC obtained Summer 2013

PATENTS

U. S. Patent 7,371,864 granted for Crystalline Forms of a Factor Xa Inhibitor (BMS)

U. S. Patent 7,388,096 granted for Crystalline Forms of a Factor Xa Inhibitor (BMS)

U. S. Patent 8,247,425 on Peripheral Opioid Receptor Antagonists and Uses Thereof. (Wyeth)

U. S. Patent 8,420,663 on Peripheral Opioid Receptor Antagonists and Uses Thereof. (Wyeth)

U. S. Patent 8,455,644 on Peripheral Opioid Receptor Antagonists and Uses Thereof. (Wyeth)

U. S. Patent 8,822,490 on Peripheral Opioid Receptor Antagonists and Uses Thereof. (Wyeth)

U. S. Patent 9,180,125 on Peripheral Opioid Receptor Antagonists and Uses Thereof. (Wyeth)

U. S. Provisional Patent Application number 61/475,098 on Formulations, Salts, and Solid Forms of Substituted Cyclohexylmethanamines and Uses Thereof. (Sunovion, formerly Sepracor)

U. S. Provisional Patent Application number 61/008,363 on salts of (s)-Zopiclone. (Sunovion, formerly Sepracor)

IN-HOUSE REPORTS & PRESENTATIONS

Co-crystals of novel DAAO compounds

Discovery and Development of New Salt Forms of SEP-225441

Recrystallization Issues of SEP-225289, a Novel Triple Uptake Inhibitor

Salt Screen SEP-228432, a Novel Triple Uptake Inhibitor

Salt Screen SEP-228425, a Novel Triple Uptake Inhibitor

Scale-up of SEP-225441 Salts

Salt Screen of SEP-225441, a Novel Compound for Panic & Anxiety Disorder

New Crystal Habit of a Thrombin Inhibitor

New Crystal Forms of Novel Anti-Thrombolytics

Lactonization of MK-733 Ammonium Salt

MSA-Catalyzed Lactonization, Process Proposal

Conversion of Batch 1-8 Diazine Acid to Pure MK-538

Optimization of MK-538 Process, Including Cross Flow Filtration of Phthalideneacetic Acid Slurry

Diazine Acid of MK-538, Campaign I Report

DETOSU, Campaign I Report

L-706,631 Crystallization of Sodium Salt

Modification of Sodium Salt Procedure for MK-476

MK-476 Diol Crystallization

MK-476 DCHA Salt Crystallization Revision and Solution Stability Study

SPECIALIZED SEMINARS & CONFERENCES

Interpretation of NMR Spectra

Chirality 2001

Pittcon 2000

HPLC & GC Method Development and Troubleshooting

Pharmacokinetics in Drug Design

Technical Writing for the Professional

Principals of Enzymology

LC-MS instrumentation and Interpretation

Mechanisms of Drug Action and Drug Design

Baker Engineering Process Safety Training

Patenting Solid Forms of Pharmaceuticals

Principals of Clinical Statistics

Practical Process Research & Scale-up

Understanding Pharmaceutical Quality by Design (QbD)

Characterization of Solids by Thermal Methods

Salt Selection and Optimization for Pharmaceutical New Chemical Entities

Beyond Salt and Polymorph Screening - Tackling Crystallization Scale-Up Challenges

The Importance of Crystal Form in Pharmaceutical Development and the Potential Advantages of Pharmaceutical Co-crystals

Workshop on pediatric formulations for assessors in national regulatory agencies

Basic GLP & GMP Training

FDA Inspection Readiness

Rapid Screening of Fake Pharmaceuticals

How pKa Values are used in the Pharmaceutical Industry

Confocal Raman Imaging and its Applications in Drug Product

Analytical Techniques for Nasal and Inhalation Technologies

The Use of Amorphous Solid Dispersions to Enhance Dissolution, and Oral Bioavailability of Poorly Water-Soluble Pharmaceuticals

High Throughput Crystallization Form Screening

API Form Selection Process, Biopharmaceutics Consideration and Evaluation

API Structure Characterization

Practical DoE and Advanced Concepts

Quality by Design

Acquity H-Class HPLC Operation and Maintenance

Pharmaceutical Preformulation: Basics and Industrial Applications

Sterilization and Aseptic Processing for Drug Product

Membranes in Bioprocessing: New Opportunities and Challenges

Understanding and Improving Drug Compatibility With Pre-filled Syringes

Integration & Gaps of Upstream & Downstream Processing & Technologies

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