Crystallization expert, design synthesis and process optimization of API crystallization and isolation (filtration and drying). Perform solubility screens and conduct early and final solid form selection of API salts, polymorphs and co-crystals. Expertise in solid state characterization including PXRD, FTIR, Raman, DSC, TGA, PLM, KF, HPLC, NMR. Design scale-up from milligram to kilogram quantities and design safe and efficient processes for commercial operations using Lasentec, FBRM, PVM, FTIR, Raman and other PAT applications. Excellent mechanical and problem solving abilities. U. S. Provisional Patent Application number 61/475,098 on Formulations, Salts, and Solid Forms of Substituted Cyclohexylmethanamines and Uses Thereof.

Associate Scientist 4 @ Solid State Characterization Carry out routine analyses of solid samples from process R&D, batch delivery (non-GMP &cGMP), and solid state studies, using XRPD, DSC, TGA, DVS, PLM, PSD, etc. Generate reports of timely analysis, following desired formats Document properly and timely lab activities Solid form screening o Take lead on solid form studies (salt selection and polymorph screening projects) o Identify and evaluate lead forms with suitable properties for formulation development o Report experimental details and results, and communicate with the client at meetings Instrument Maintenance and Repair o Lead efforts to ensure all solid state characterization instruments are functioning properly at all times o Keep track records of activities related to maintenance, repair, calibration, safety, etc., especially for cGMP instruments Support of Crystallization Process Development o Assist in equipment setup, maintenance, repair, etc. o Participate in design of crystallization processes. From January 2015 to April 2015 (4 months) PDT, Lab Supervisor @ PDT, DPST Aseptic Technologies Laboratory Supervisor Assist scientists in the evaluation and development of new drugs in development and stability laboratories, as well as in the pilot scale processing operations. Laboratory assignments include the following: preparation of buffers and other media, potency and degradant analysis, dissolution analysis, physical and mechanical testing of finished dosage forms and intermediates. Familiarity with test equipment such as: HPLC systems (H Class Acquity), automated UV diode array dissolutions systems, and 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 20 formulation scientists in the development of new dosage forms using process equipment such as, GPC, SDS-PAGE, Western Blot, Micro Flow Imaging (MFI), Dynamic Light Scattering, HIAC, lyophilizers, autoclaves, and computer assisted data acquisition of process information. 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. SAP trained to supply labs and operational areas. Conduct characterization studies on new drug candidates. Develop parenteral dosage forms for clinical and commercial use, and conduct optimization and scale-up studies. Assist in the design for 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. From December 2011 to December 2014 (3 years 1 month) Research Chemist @ Small molecule organic synthesis of energetics defining route selection, scale up to pilot plant and solid state characterization using DSC, FTIR, PXRD and Raman. Performed process optimization, crystallization and polymorph studies. Secret Security Clearance granted. From August 2009 to January 2011 (1 year 6 months) Senior Analytical Research Chemist @ Apply creative ability and specialized scientific knowledge methods to solving marketed product large scale analytical problems or evaluating changes to APIs and critical excipients used in marketed products. 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 (e.g., complex investigations, forensic analysis, PAT-related). 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. From June 2009 to August 2009 (3 months) Process Research Chemist @ Conduct synthesis of pharmaceutical intermediates and drug candidates for the Chemical Process Development Group with focus on crystallization evaluation and reaction engineering from scale-up to kilo lab. Develop in-process assays, asymmetric synthesis methods and technologies, and conduct impurity isolation. Routinely use Empower HPLC, chiral 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. Perform crystallization and safety experiments using RC-1, Lasentec, and Crystal 16 instruments. Use InPhotonics Raman and IC-10 React-IR for crystal form characterization and in-situ reaction characterization. As the key chemist, routinely conduct polymorph screens, co-crystal screens, salt form screens, chiral resolution screens and define parameters needed to select final form and crystallize novel anti-depressant candidates. From May 2006 to February 2009 (2 years 10 months) Process R&D Research Chemist @ Process R& D position for pilot plant support up to phase I studies. Responsibilities include performing synthetic 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, NMR and other instrumental techniques as required. Purification of reaction products via crystallization together with complete characterization using solid state NMR, LC-MS, 1H, 13C techniques and DSC is done regularly. Perform crystallization experiments using Lasentec and salt and polymorph screens to determine crystal habit and form. From April 2005 to October 2005 (7 months) Discovery Pharmaceutics Chemist @ Discovery Pharmaceutics Chemist, 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 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 granted two patents for discovery of new crystalline forms of novel Factor Xa drugs. Supported 12 therapeutic programs at four facilities. From May 2003 to April 2005 (2 years) Staff Chemist @ Crystallized the first pure and stable neat form of MK – 0476 (Montelukast) sodium salt and defined PSD by controlling crystallization parameters. Provided sub-kilo and kilo scale synthesis support for numerous medicinal research teams to design and scale up multi-step schemes up to 100 liter and provide drug and drug intermediates for safety assessment candidates and structure activity relation studies. Provided technical and scientific 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. From 1988 to 2002 (14 years) Technical Service Research Chemist @ Technical Service Chemist in the Minerals and Fillers Group. Use of kaolin and other silicates to modify properties of engineering thermoplastics and elastomers. Operate 2 roll mill, single screw molding injection machine, 20 ton press, muffle furnace, Instron test machine, various mills and powder processing equipment. Patent work initiated for blister-proof gel coats for marine application. From 1983 to 1988 (5 years)

Master's Degree, Material Science @ Stevens Institute of Technology From 2010 to 2016 BS, Chemistry @ New Jersey Institute of Technology From 1989 to 1995 Carteret High SchoolUniversity of California, Davis Steven Fabian is skilled in: SALT, HPLC, Formulation, Chemistry, Crystallization, Drug Discovery, Organic Synthesis, GLP, LC-MS, FTIR, Purification, GMP, TGA, R&D, NMR, Analytical Chemistry