Quality Control Clinical Research

Main 201-***-****

Fair Lawn, New Jersey

********@*******.***

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, NY

Supervisor - 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, NJ

Scientist - 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, NJ

Scientist - 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,

NJ

Scientist - 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, NJ

Histology 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, NJ

Medical 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, NJ

Scientist - 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

Education

9/1996 - 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

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