Idiculla Alexander

*** ********* ***, **** ***, SC 29708

ac7vse@r.postjobfree.com

Tel: 803-***-****

PROFESSIONAL EXPERIENCE

Haemonetics Corporation, Union, SC Jan 2017- present

QC/QA Chemist

Raw Materials, Work-In-Process, Finished Products for product approval and releases.

Performs physical and chemical testing in accordance with standard procedures, utilizing wet-chemistry, process water testing, compressed air testing, and basic instrumental techniques.

Maintains accurate, up-to-date and concise laboratory notebooks and records

Understand and precisely follows Standard Operating Procedures, global methods, local/international methods and published standard methods i.e. USP/ISO

Provides training to employees on new and existing Standard Operating Procedures (SOP)

Provides support to the Operations personnel with analytical equipment and testing procedures.

Capable of operating and performing basic troubleshooting on analytical instruments (pH, Conductivity, TOC, Osmometer, Polarimeter, Autotitrator, Karl Fischer, Ion Chromatography, UV-Vis and FTIR)

Responsible for daily/monthly instrument calibrations to ensure all instruments are working properly

Participates on Out of Specification (OOS) investigations to collect the necessary samples and information to complete Laboratory Investigation Reports (LIR)

Understands and applies basic laboratory safety instructions, reagent handling precautions, and disposal of chemical waste according to local environmental regulations.

Working knowledge and practical experience with cGMP, GDP, GLP and FDA regulations in a chemistry laboratory environment.

Familiar with quality systems [i.e. Laboratory Investigation Reports (LIR), Corrective and Preventive Actions (CAPA), calibration, validation, change control, etc.]

Batch record review and laboratory log book review.

Works as a member of the Laboratory Team to complete all required tasks in a timely manner

Communicate Effectively - Clearly and simply expresses ideas and concepts

Ability to plan, prioritize and adapt to circumstances as needed.

Set a positive example for conducting business in an ethical manner, managing stress, and creating a pleasant and balanced work environment.

Proficient knowledge of computer and computer software: Excel, Word, Power Point, Etc.

Amgen, Woburn, MA Aug 2014 - Feb 2015

Manufacturing Associate

Performed protein purification (downstream) process through IEX and SEC column chromatography techniques with AKTA Ready system and Unicorn control software.

Performed UF/DF process with SciLog SciPure 200 Automated TFF Skid.

Performed column packing techniques and qualification.

Worked fill/finish activities of final drug product.

Performed final inspection, labeling & freezing of final drug product and buffer preparation.

Reviewed manufacturing batch production records and documents.

Pfizer Pharmaceuticals, Andover, MA. Jan 2013 - Jun 2014

Bench Scientist (Manufacturing Science &Technology)

Worked independently on protein purification process developments and analytical techniques daily: Chromatography (IEX, SEC, Affinity, CHA, & HIC), Ultra filtration / Dia-filtration, TFF and normal flow filtration, SDS-PAGE, UV Spectrophotometer, Nano Drop, ICP, pH, conductivity, AKTA Cross flow, AKTA AVANT, AKTA Purifier FPLC Systems / Programming Unicorn Software.

Performed product recovery/clarification, Filtration process.

Performed Design of Experiments (DoE) to optimize unit operations for high process performance.

Worked Tangential Flow Filtration: Ultra filtration & Nano filtration in various modes (flat sheet, hollow fiber)

Performed the characterization of proteins by HPLC (IEX/SEC) and evaluation of chromatographic performance.

Performed Colum packing and column qualification.

Performed the preparation of laboratory buffers & formulations, and sample preparation.

Performed summarize data and write laboratory reports through Electronic Lab Notebook for executed experiments.

Performed process monitoring using variety of data analysis methods and techniques such as Excel, JMP, SAP & Empower.

Biogen Idec, Cambridge, MA Mar 2012 - Dec 2012

Manufacturing Associate Aug 2008 - Apr 2010

Performed protein purification process through different column chromatography activities which include the following Blue Sepharose column, SP Column, Zinc column, Viral filtration, and UF/DF

Worked harvest clarification, TFF, NFF, depth filtration, and viral filtration process.

Worked on analytical instrumentation such as pH, conductivity, Osmometer, Endo Toxin Tester, and UV spectrophotometer.

Performed Column packing and column qualification.

Performed cGMP/GDP activities within the plant, which included monitoring environmental charts, monitored and standardized small equipment like process scales, and tanks.

Performed operation on system that operates with Delta V, Umetrics SIMCA Batch Online, and Unicorn software.

Performed manufacturing review of Batch Production Records and logbooks.

Genzyme, Framingham, MA Apr 2010 - Jun 2011

Manufacturing Senior Tech.

Worked protein purification process through different column chromatography techniques.

Performed harvest clarification, TFF and normal flow filtration.

Performed unformulated bulk drug process (UF/DF) and formulated bulk drug process (Nano Filtration).

Worked column packing techniques and column qualification.

Reviewed batch production records and manufacturing documents, iLIMS and MfgPro software

QC Lab Testing: Appearance, Reconstitution time, pH, Conductivity, UV/Vis Spectroscopy, FTIR, SDS-PAGE, HPLC, GC, TOC, Mocon Oxygen Headspace Analysis, ELISA, Activity Assay, Automatic Titration, and Karl Fisher Titration.

Luvac Analytical Laboratory, Boylston, MA May 2006 - Nov 2007

Lab Chemist

Performed chemical and physical testing of material samples such as water, petroleum products, graphite, concrete cubes, tapes, paints, silicon pastes, other organic and inorganic samples.

Performed gravimetric analysis of carbon, ash, volatiles, and moisture content for graphite samples.

Performed analysis of gases (H/O/N) & total nitrogen by Kjeldhal method

Performed wet chemistry techniques for organic and inorganic testing.

Instrumentation: pH Meter, Conductivity Meter, Viscosity Meters, Refractive Index, Ion Chromatography, GC, UV, AAS, Mercury Analyzer, Graphite Furnace, Ion Selective Electrode, Karl Fisher, Automatic Titrators, Direct Current Plasma (DCP), TOC, Thermal Analysis, Distillation Unit, Extraction & Purification Units, C, S, H, & O analyzer (LECO), FTIR, and TOC

Environmental Laboratories, Boston, MA Jul 2003 - Jan 2006

Lab Chemist

Performed organic extractions of water, and soil samples

Worked preparation of laboratory reagents and standards (spike & surrogates).

Managed samples and generate reports through Laboratory Information Management system (LIMS)

Performed organic extraction of soil/sediments, tissues, and water for Pesticides, PCBs, SVOCs, EPH, and TPH Automatic silica gel fractionation techniques of aliphatic and aromatic hydrocarbons.

Performed inorganic extractions of soil/sediments, tissues, and water for metal analysis

Worked method development of solid phase extraction and spinning method extraction techniques.

Performed the determination of the percentage of lipid, solid, and moisture of tissues samples. Water, soil/sediment, tissues sample preparation for metals.

Performed the creation of batches, weight entry, spike reports, sample prep reports, and clean up reports through LIMS system.

Instrumentation: Analytical balance, Column Chromatography, Automatic mixture, Automatic Solvent Extractor, and Sonicator.

Lonestar Analytical Laboratory, UAE Feb 94 – Oct 98

Analytical Chemist

Performed chemical and physical, and analysis of water and wastewater.

Performed chemical and physical analysis of petroleum products

Performed chemical analysis of steel (ferrous & nonferrous), and alloys.

Performed chemical and physical analysis of scales/deposit samples to find out chemical composition.

Worked purity determination of fine chemicals such sodium chlorides, calcium carbonates, magnesium chlorides, and drilling fluids samples (barite, bentonite, hematite, etc.)

Performed the preparation and standardization of all lab reagents & preparation Chemistry reports.

Instrumentation: Performed analytical instruments such as, pH meter, conductivity meter, turbidity meter, Karl fisher Titration Meter, Distillation Unit, Vapor pressure unit, Kjeldhal Apparatus, Hydrometers for API gravity, Flash point, freezing point, cloud point, Viscosity apparatus, Water by distillation unit, Moisture balance, GC, UV-Vis

Spectrometer, Atomic Absorption Spectrophotometry, Rheology meter and FIA unit.

Polymer Industries, India Nov 88 – Dec 93

QC Chemist

Performed chemical and physical analysis of polyester yarns and chips. Performed chemical and physical analysis of intermediates products of polymer solution. Performed chemical and physical analysis of raw materials such as PTA, Mono-Ethylene Glycol, and Titanium Dioxide.

Performed physical and chemical analysis of thermosetting plastics finished products. Performed physical and chemical analysis of intermediates products of polymer solution. Performed physical and chemical analysis of raw materials (urea, melamine, phenol, formaldehyde, wood pulps, and TiO2).

EDUCATION

Bachelor of Biomedical Laboratory & Clinical Science, 2012, Boston University, Boston, MA

Bachelor Degree in Chemistry, 1987, University of Kerala, India

Associate Degree in Biotechnology, 2009, Middlesex Community College, Bedford, MA

Associate Degree in Computer Technology, 2002, Fisher College, Boston, MA

Contact this candidate