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Quality Assurance Maintenance

Location:
Garden Grove, CA
Posted:
September 25, 2014

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Resume:

Michael Levandoski, Jr. Ph.D.

SUMMARY A highly trained molecular biologist, cell biologist, and microbiologist with experience in molecular diagnostic and mammalian expression systems seeking to expand expertise, increase responsibilities and further career development. Serves as a liaison between the research department and QA/QC departments by overseeing the transition of assays from research to operations by training technicians on novel research techniques, as well as creation and execution of SOP’s and validation protocols. Adept at analyzing data, designing and managing multiple independent research projects, troubleshooting and problem solving. Experienced in lab management and administrative lab duties. Takes an active role in designing maintenance protocols, as well as preventative maintenance, repair, and trouble shooting research and operational machinery. Previous microbiology and molecular biology experience in FDA regulated lab with knowledge of Good Manufacturing Practices (GMP’s) as well as Standard Operating Procedures.

ACADEMIC BACKGROUND

Ph.D. Microbiology and Molecular Genetics

Dissertation: Finding intracellular sites where mRNA molecules containing premature

termination codons are recognized and degraded.

University of Medicine and Dentistry of New Jersey, Newark, NJ

Graduate School of Biomedical Sciences - Public Health Research Institute

Bachelor of Science in Biology (minor: Biochemistry), 2005

Fairleigh Dickinson University, Madison, NJ

RESEARCH & WORK

EXPERIENCE

RESEARCH SCIENTIST

National Genetics Institute/Labcorp 310-***-**** 2012-Present

* Molecular Diagnostic Techniques including Multiplex PCR (Polymerase Chain Reaction) End Point Processing, including Southern Blotting and Luminex xMAP detection, Real-Time PCR

* SOP (Standard Operating Procedures) creation, development, and in-process modifications

* Creation, Tracking, and Resolution of Deviation Reports

* Liaison between QA (Quality Assurance) Department and Research Department to facilitate transition of research methods to operations

* Preventative maintenance and repair of laboratory equipment

* Engaging in the early design of research projects for rapid transition to operational status

* Analysis of data and troubleshoot issues including unexpected results and aberrant controls.

* Responsible for training lab technicians in novel research methods

* Supervision of multiple research projects in parallel

* Extensive knowledge of compliance procedures and policies in order to satisfy governmental and client regulations

* Responsible for developing new research methods and improving existing research and operational processes

* Coordinate validation activities to meet critical project deadlines and product launch dates

* Prepare, review and/or approve written documents to support operational assays and validation projects.

* Proactively identifies potential issues and develop creative and novel solutions to technical problems in order to keep both research and operational assays on schedule

* Forms relationships with outside vendors to reduce overall costs of reagents and lab equipment

* Designing and creating molecular probes

* Experience with IND submissions (Investigational New Drug) and CAP(Collage of American Pathologists) accreditation

DOCTORAL RESEARCH

Lab of Drs. Sanjay Tyagi & Fred Kramer, University of Medicine & Dentistry 2006-2012

* Investigation of the nonsense mediated decay pathway using single molecule detection methods, as well as, alternative splicing, natural gene regulation, and RNA transport.

* Expert in fluorescence microscopy including fluorescence in situ hybridization

* Designing and creating molecular probes

* Design and creation of clonal vectors for use in mammalian expression systems

* Mammalian cell line selection, isolation, maintenance, storage, cataloguing, and developing using but not limited to CHO, HeLa, HEK293, MeWo, COS cells

* Expert in cell line creation using chemical transfection and viral transduction methods

* Expert in cell line selection using chemical selection, serial dilutions and fluorescence activated cell sorting (FACS)

* Design and maintenance of cell-based assays for use in laboratory processes and projects

* Use of flow cytometry for data collection

* Analysis of flow cytometry data

* Preparation of organisms and solutions for sequencing reactions

* DNA and RNA preparation using but not limited to Maxiprep, Midiprep, Miniprep, and RNeasy

* Analysis of sequencing data including accessioning, aligning sequencing using basic local alignment search tools, and sequence alignment programs.

* Experience with virology and parasitology

* Organization of lab, preparation of media, purchase orders, overall lab maintenance and overseeing functionality of lab equipment

Microbiologist

SGS U.S. Testing, Co. Fairfield, NJ 973-***-**** 2006

* Preparing media and reagents

* Practiced aseptic techniques

* Understanding and following Standard Operating Procedures (SOPs) USA and European SOPs

* Accountable for quality assurance tasks

* Conducting sample analysis and meeting deadlines

* cGMP Practices

* cGMP Manufacturing

* Vitek machine experience

PUBLICATIONS Vargas, Shah, Batish, Levandoski, Sinha, Marras, Schedl, & Tyagi, 2011. Single-Molecule Imaging of Transcriptionally Coupled and Uncoupled Splicing. Cell. 147(5): 1054-65.

Levandoski, Tyagi, (Publication in process) Finding intracellular sites where mRNA molecules containing premature termination codons are recognized and degraded.

TECHNICAL LABORATORY

SKILLS

Biosafety Level 2- trained and experienced in BLS-2 facility, as well as animal testing & animal facilities.

Underwent radiation safety training and is experienced in using radioactive materials in a laboratory setting.

Expert in microscopy, general RNA work procedures, real-time PCR, reverse transcription real-time PCR, Northern blotting procedure, Southern blotting procedures, single molecule in situ hybridization, mammalian tissue culture work, protein purification and western blotting.

Adept at many standard microbiology, genetics and molecular techniques including cloning, gene knockout creation, site-directed mutagenesis, DNA isolation and purification, DNA and protein gel electrophoresis, plasmid DNA procedures.

Experienced with light and fluorescence microscopy and associated data analysis, including MATLAB and Openlab.

REFERENCES

Dan Del Mastro, President & CEO, Aero-Med, Ltd. 85 Commerce St., Glastonburgy, CT 06033

acf41s@r.postjobfree.com, 860-***-**** X214

Dr. Sanjay Tyagi, Public Health Research Institute at University of Medicine and Dentistry, 225 Warren Street, Newark, NJ 07103. acf41s@r.postjobfree.com, 973-***-****

Dr. Fred Kramer, Public Health Research Institute at University of Medicine and Dentistry, 225 Warren Street, Newark, NJ 07103. acf41s@r.postjobfree.com, 973-***-****

Dr. Salvatore Marras, Public Health Research Institute at University of Medicine and Dentistry, 225 Warren Street, Newark, NJ 07103. acf41s@r.postjobfree.com, 973-***-****

Dr. June Middleton, Fairleigh Dickinson University, 285 Madison Ave, Madison, NJ 07940. acf41s@r.postjobfree.com, 973-***-****

25935 Rolling Hills Road, Apt. 305, Torrance, CA 90505 973-***-**** email acf41s@r.postjobfree.com Page PAGE 3



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