Sarah Simmerman Email & Phone Number

Columbus, Oh, Us

Shirley, New York, Us

Shirley, New York, Us

Process development for injectable drug products. Design and execute lab-scale and production-scale studies to introduce new and existing products into 3 cGMP manufacturing sites. Work with Production, Engineering, QA, and Validation departments for equipment qualification, process scale up, optimization, process validation, and commercial investigations. Author engineering protocols/reports, technology transfer reports, risk assessments, review Master Batch Records, and open TrackWise change controls. Author documents supporting ANDA/NDA/NADA submissions and technology transfers. Follow ICH, USP. • Selected as Process Lead overseeing development, transfer and submission activities• Perform FMEA risk analysis for technology transfers, scale up, and optimization• Perform lifecycle management activities such as impact assessment for supplier notifications• Assist with Pilot Lab operations and equipment purchasesSoftware: TrackWise, MiniTab, Microsoft Visio, BPCS, Microsoft Office (Word, Excel, Outlook, PowerPoint), Veeva, DocuSign, Chromeleon, WorkdayInstrumentation: HPLC (Agilent 1260), UPLC (Agilent 1290), Dissolution

London, London, Gb

Formulation, analytical, and process development for injectable liquid, lyophilized, suspension and peptide drug products in vial, syringe and IV bag. Author documents supporting ANDA/NDA/505(b)(2) filings and technology transfer. Follow ICH, USP. • Assisted with the research required for four patent filings• Received a service award, September 2018• Selected as Project Lead overseeing development, transfer and submission activities for drug products• Perform FMEA risk analysis for Quality by Design developmentSoftware: Waters Empower 3, MiniTab, Microsoft Visio, Microsoft Office (Word, Excel, Outlook, PowerPoint), Instrument software, UltiproInstrumentation: HPLC (Agilent 1200/1260), UPLC (Waters Acquity, Agilent 1290), GC (Agilent 6890N/7890B), Particle Size and Peptide Aggregation analysis (Malvern Mastersizer, Zetasizer, and NanoSight)

London, London, Gb

Formulation and analytical development for injectable liquid and lyophilized drug products. Authored documents supporting ANDA filings. Performed API evaluation and vendor selection. Followed ICH and USP.

Ingelheim Am Rhein, Rhineland-Palatinate, De

Developed formulations and analytical methods for generic injectable drug products. Prepared documents supporting ANDA filings including protocols, reports, and methods. Followed ICH guidelines, cGMP regulations, and pharmacopeias (USP, EP and JP). Software: Waters Empower 2, Enterprise Content Management (ECM), IDEA for CON, IDEA for GEN, QAD MFG/PRO, Microsoft SharePoint, CISPro, Learning One Source (LOS), Instrument software, Microsoft Office (Word, Excel, Outlook, PowerPoint)Instrument/Technique: Agilent 1200 HPLC, Waters Acquity UPLC, FT-IR, UV-Vis, Wet ChemistryTesting: Quality by Design (QbD), Material Compatibility, Container Closure, Decontamination, Thermal cycling for cold chain distribution, Raw Material/In-Process/Final Product release testing, Stability testing

Ingelheim Am Rhein, Rhineland-Palatinate, De

Tested Active Pharmaceutical Ingredients (API), excipients, vials, and stoppers for sterile injectable drug products. Followed cGMP regulations and pharmacopeias (USP, EP and JP).Software: Waters Empower 2, EvoLS (LabWare LIMS database), QAD MFG/PRO, Instrument software, Microsoft Office (Word, Excel, Outlook)Techniques: HPLC, FT-IR, Raman, ATR, UV-Vis, Karl Fischer Titration, Optical/Specific Rotation, Turbidity, Osmolarity, Melting Point/Range, Specific Gravity, Heavy Metals, Residue on Ignition, Loss on Drying, Chemical Identification, Moisture Determination, Density, pH, Crystallinity

Indianapolis, Indiana, Us

Tested pharmacokinetic pre-clinical samples for drug compounds using LC-MS/MS. Developed in vivo & in vitro methods and analyzed results. Complied with Good Research Practices (GRP).Software: Watson LIMS database (helped test new version), Automation Software, Sciex Analyst, ISIS/Base & Isentris, Rubicon, Microsoft Office (Excel, Word and Outlook)Mass Spec/HPLC: Triple Quadrapole Mass Spectrometers (AB Sciex API 4000 & 5500 LC-MS/MS), Gilson Autosampler, CTC HTS PAL Autosampler, Shimadzu HPLC PumpsAutomation & Liquid Handlers: Tomtec Quadra 96, Hamilton Microlab STAR (utilized LabVIEW 8 to program)

Indianapolis, Indiana, Us

Performed high-throughput enzyme assays of candidate drug compounds. Utilized automated platforms. Analyzed data. Gained exposure to bioassay design. Complied with Good Research Practices (GRP).Software: IDBS ActivityBase XL and XE, Jockyss S-Plus, RunBuilder, Mobius, IDBS XLfit, Automation Software, Microsoft Office (Excel, Word and Outlook)Automation/Liquid Handlers: Tecan Freedom EVO, Tecan TeMO, Beckman Coulter Multimek 96/384, Titertek Multidrop, Genetix Qfill, Matrix WellmateReaders (Radiation/Fluorescence): PerkinElmer EnVision, Molecular Devices Analyst GT, Tecan Genios Pro, Trilux, PerkinElmer Victor X, MSD Sector Imager, Beckman Coulter Vi-Cell, Beckman Coulter LS 6500 Scintillation Counter

Indianapolis, In, Us

Genetically modified (transformed) crop plant tissue. Performed nanotechnology techniques and cell culture both on solid media and in liquid suspension. Complied with Good Laboratory Practices (GLP) standards.Seminars attended: Nanotechnology, Purdue Research Park's research, Genetically modifying maizeSoftware: Transaction Transbase (database), Microsoft Office (Excel, Word), IBM Lotus Notes

Bachelor’S Degree, Biology

Web Application Development Certificate, Information Technology - Programming And Development

Information Technology

Education record