Main 201-314-0956Fair Lawn, New Jersey msbsbiol@hotmail.com

Oscar A. Lara

Objective To obtain a position within a pharmaceutical or biotechnology company that will exercise my experience and education for the success of the company.

Experience

8/2007 – 12/2014 Regeneron Pharmaceuticals, Inc. Tarrytown, NYSupervisor – Bioanalytical Analyst

Managed daily activity, operational development and maintenance of the following studies: IL-1 Trap, REGN1033, REGN88 and REGN668 programs; coordinate other research associate daily task in and out of the lab. Review and verify data results, review, write and made updates to SOP, SAR and assay forms. Update management on timelines deliverables.

Performed on a day-to-day basis routine ELISA assay for clinical sample analysis in the area of Oncology, Ophthalmology and Inflammatory. Ongoing quality review of data and ensure full compliance of the analyzed data.

Operated under established internal SOPs, safety guidelines and regulations, and as specified by appropriate external regulatory agencies (e.g., FDA); working framework consist of cGMP/GLP and Regeneron Pharmaceuticals, Inc. safety regulation standards.

Amassed extensive expertise with Tecan instrumentation (Freedom EVO platform), CRS and Gemini software. Participated in training activities to maintain/enhance skill level personally and for the SAG. Maintained an up to date laboratory notebook that recorded experimental methods, materials and results. Generated written technical sections of internal and external reports, protocols or SOPs that require minimal

revisions. Reviewed sample results for accuracy for when reports and documents are written. Provided scientific and technical supervision to junior staff, including initial training, ongoing instruction, planning

detailed procedures for defined projects with timelines, methodological approaches, expected results and necessary resources.

Responded to potential issues with equipment and/or supplies, and initiates action to solve or prevent other issues from occurring

Worked closely with direct reports and other analyst to operate and demonstrate understanding and knowledge using MVS (Artel) pipetting accuracy instrumentation

Worked closely with direct reports and other analyst to operate and demonstrate understanding and knowledge using BioTek's new MultiFlo™ Microplate Dispenser instrumentation

Prepared and qualify reagents / Order laboratory supplies. Worked closely with outside vendors to purchase new equipment or lab ware for the enhancement of the lab.

Conducted and attended weekly team meetings. Reviewed all data (notebook documentation, raw data, and LIMS data), study reports, assay validation

reports and other documentation in a timely manner to meet project timelines. Worked side by side with other preclinical departmental groups for the benefit of the company. Close interation with

project management team to coordinate timeline deliveries. Forecast plans for the upcoming programs and expectations for the SAG. Attend and participate in QA audits and QA closeouts of studies.

Worked independently and communicate critical and non-critical information to senior management for key making actions taken within the group and assigned projects.

Used a sample tracking system (LIMS) to review sample inventory against samples received to determine accuracy and to maintain sample integrity.

Managed post-audit activities and follow-up on any necessary corrective and preventive actions; resolved any conflicts.

2/2007 – 8/2007 Ortho-Clinical Diagnostics, a J& J company (Contract through Kelly) Raritan, NJScientist – Test Methods Development & Validation Department

Performed day-to-day test method development and validation under direct supervision. Evaluated and validated immunohematology related test methods for accuracy, precision, robustness and specificity. Prepared basic reports and summaries, including quantitative analysis. Coordinated validation studies for new development, adaptation and validation of test method protocols for in-

process and release testing of immunohematology related products with quality assurance and control, manufacturing, planning and documentation groups.

Developed assays/tests for raw materials or components and validated test methods for required properties. Created/modified test methods (TMs), batch records (MBRs), SOPs and specifications as required.

Exercised judgment within defined practices and polices in selecting methods and techniques for obtaining solutions to problems of up to moderate scope and complexity.

Maintained lab equipment and supply levels current to daily operations. Made decisions, recommendations and obtained results contributed to the progress of the test methods program

schedule. Recorded and documented work of others and myself to levels required by QSR for design and development. Participated in routine training activities. Adhered to regulations and guidelines of all applicable regulatory agencies, such as FDA (QSR/cGMP), OSH, ISO

(including ISO 14001), J&J and OCD Health, Safety and Industrial Hygiene. Maintained an up to date laboratory notebook that recorded experimental methods, materials and results.

1/2006 – 10/2006 Hoffmann La Roche (Contract through Adecco) Nutley, NJScientist – Pre-Clinical Research & Development / Metabolic Disease Department

Performed primary and secondary screening assays for compounds synthesized to identify activators of Glucokinase (GK).

Worked on a small team, one of five programmers, to create a fully automated system for the optimization of the Glucokinase (GK)

Responsible in performing spectrophotometric assays measuring the production of glucose 6 phosphate via detection of change in absorbance of Nicotinamide adenine dinucleotide (NADH) produced in coupling reactions.

Performed biochemical assays and ELISA format assays on a daily basis (average tested 300 compounds a week)

Performed laboratory experiments utilizing establish internal and published procedures. Maintained an up to date laboratory notebook that records experimental methods, materials and results. Contributed to writing presentations pertaining to work being conducted for both internal and external publication;

prepared and presented oral presentations of work at project team meetings. Worked within the framework of OSHA, cGMP/GLP and safety regulations. Contributed to updating and amending Activity Base excel template for GK project database. Participated in routine training activities. Attended in-house seminars and presentations related to metabolic diseases research. Contributed to developing a primary high throughput screen protocol/assay for the GK project.

8/2003-9/2005 Hoffmann La Roche (Contract through Adecco) Nutley, NJScientist - Pre-Clinical Research & Development / Metabolic Disease Department

Cultured and prepared primary rat and human hepatocytes for diabetes target drug discovery. Conducted assays (both enzymatic and cell based) to identify and validate potential anti-diabetic or anti-obesity

agents. Cells were used to measure glycogen content after treatment with target compounds. Trained on GPCRS, lipid biochemistry and permeability assays.

Performed ELISA based assays, SDS-PAGE, immunoblotting functional and binding assays. Performed laboratory experiments utilizing establish internal and published procedures. Maintained an up to date laboratory notebook that records experimental methods, materials and results. Contributed to writing presentations pertaining to work being conducted for both internal and external publication;

prepared and presented oral presentations of work at project team meetings. Worked within the framework of OSHA, cGMP/GLP and safety regulations.

10/2002-8/2003 Huntingdon Research Center East Millstone, NJHistology Technician I Prepared and analyzed of specimens including both non-decalcified and decalcified processes Prepared fixatives and solutions for electron microscopy studies. Performed necropsies, perfusions, and anesthetic injections on various lab animals. Sectioned, trimmed, microtome and embedded hard and soft tissues to make histological slides.

2/2002 – 8/2002 Quest Diagnostics (Contract through Judge) Teterboro, NJMedical Technologist, Serology Department

Routine and none routine activities pertaining to laboratory testing and results. In-house training on HPLC procedures. Followed laboratory procedures for specimen handling and processing, reported and maintained records of patient

test result. Maintained records that demonstrated that proficiency-testing samples were tested in the same manner as patient

specimens. Reviewed and released test results. Followed CLIA, HIPAA, OSHA, and safety guidelines as described in their respective guidelines. Adhered to the laboratory's quality control policies, documented all quality control activities, instrument and

procedural calibrations and all maintenance performed. Identified problems that adversely affected test performance or reports of test results, corrected the problems

encountered or immediately notify the senior technologist or supervisor.

7/2001 – 2/2002 Hoffmann La Roche - RMS (Contract through Joule) Branchburg, NJScientist – Production / Detection Formats Department

Performed release testing in a quality control laboratory according to approved procedures under cGMP, Safety, and Regulatory guidelines of PCR based diagnostic kits for detection of HIV and HCV.

Executed laboratory assays, performed routine tests, and analyzed and validated data to support the RMS production schedule.

Performed work according to established internal SOPs, safety guidelines and regulations, and as specified by appropriate external regulatory agencies (e.g., OSHA, FDA).

Assisted with the execution of validation protocols and the writing and/or revision of documents (e.g., SOPs, BPRs) to comply with cGMP practices.

Participated in routine lab maintenance, lab safety, ISO, and GMP/QSR implementation. Participated in routine training activities to maintain/enhance skill level. Maintained an up to date laboratory notebook that records experimental methods, materials and results

Education9/1996 – 5/2001 Fairleigh Dickinson University Teaneck, NJ Masters/BS, Biology. Graduate courses included : Molecular Embryology, Cell Culture, Molecular Genetics, Human Genetics, Nucleic

Acids: Structure & Function, Enzymology, Endocrinology, Pharmacokinetics, Advanced Microbiology, Physiological Ecology.

Research

Fairleigh Dickinson University, July 2001 - October 2001 Molecular Micro-techniques: (H&E TECHNIQUE) The protocol applied routine staining of tissue components of

the Bola shark's ocular lens. Purification of single-stranded oligonucleotides. Observation and recording were done by means of the light microscope, notes, photomicrography, drawing and labeled sketches.

Arch Histol Cytol 2001 Oct;64(4):379-91

Fairleigh Dickinson University, January 2003 - May 2003 Antimicrobial Creams Based on Hops: Evaluated the substitution of a hop ingredient (lupulone) for antibiotics in

creams and ointments. Compared several hop-containing cream and ointment formulations to find a composition, which showed maximum activity in a diffusion test.

Skills Microsoft Windows 2000, Windows XP, Excel Fit, PowerPoint

LIMS Nautilus 8, QUMAS, GraphPad Prism 3.02, KaleidaGraph, FileMaker Pro, SoftMax PRO 4.0.1, Activity Base, Imaging Densitometry: Quantity One 1-D Analysis, Online Total Integration System (OTIS), SoftMax Pro 4.7.1 Enterprise, SAS Drug Development, Gemini, Polara

Languages Speak, read, write and understand Spanish

Hobbies Play seven musical instruments