Development Product
Resume:
Cell: 908-***-****
Home: 908-***-****
E-mail: acz63r@r.postjobfree.com
Internet: http://www.linkedin.com/in/brucesodowich
Career Objective
My objective is to contribute to the business growth of the Pharmaceutical and Biotechnology industries by employing my strong background in the Life Sciences. I have experience in Research, Development, and Operations.
BioArray Solutions Ltd, An Immucor Company, Warren, New Jersey – Research and Development
Development Scientist II, January 2013- April 2017
Primary functions were to conduct feasibility and optimization, validation, and verification experiments in support of IVD assay development in the area of immunohematology, transplantation, and other disease models on the BeadChip Genetic MicroArray Platform.
Research
Performed a feasibility study of the use saliva as a source of genetic material for the genotyping of blood group genes and presented the findings at the 2013 AABB annual meeting
Designed and tested over 60 novel PCR primer sets using the NCBI Gene database and Geneious cloning software for sequencing blood group gene targets for customer sample investigations
FDA submission and Quality System support
Executed protocols and wrote reports for PreciseType HEA and HPA test 510k submissions
Studies include Accuracy, Precision, Guardband, Accelerated and Real-Time Stability
Drafted and transferred technical documentation such as work instructions and SOPs to Operations for the manufacture of PreciseType HPA test kits
Product and Process Design and Improvement
Updated manufacturing documents and prepared research lots of HEA LR BeadChip kits
Performed feasibility experiments on an HEA extended panel project containing additional RBC antigens and variants
Performed equivalency studies on enzymatic assay reagents formulated with alternative DNA polymerases for improved cost effectiveness
Tested, prepared, and corrected the sequences of plasmids used as positive controls for BeadChip assays
Technical and Customer Support Accomplishments
Developed a Whole Genome Amplification process for replenishing critical DNA samples for Quality Control activities
Performed a search for cell line DNA on the NCBI SNP database for sample with specific genotypes in support of QC activities
Established a DNA sample repository with reference genotyping for R&D and QC departments
Performed genetic analysis for sample investigations wrote reports for discrepant customer sample results
Established trending analysis of customer complaint data
As part of a cross-functional team, performed a critical product investigation on HEA BeadChips
Software Group Support
Executed software verification protocols for 510k submissions including proprietary Immulink software
Health and Safety
Designed and implemented a site wide safety audit procedure and trained all laboratory personnel in alignment with company objectives
Zeus Scientific, Incorporated, Branchburg, New Jersey – Research and Development
Scientist, Department of Research and Development, April 2007-January 2013
Co-Developed a Novel, Highly Sensitive DNA Polymerase Activity Assay which Universally Detects Viable Microbes
Development of Molecular In Vitro Diagnostic (IVD) Tests for Bacterial Pathogens
Designed and optimized PCR based detection assays for S. aureus, C. difficile, and Group B Streptococcus
Optimized specimen preparation
Designed validation protocol experiments for diagnostic tests (510k submission requirements)
Designed manufacturing procedures for semi-finished and finished reagents
Microbiology Experience
Grow, plate, and titer a variety a microbiological organisms, both aerobic and anaerobic, pathogenic and non-pathogenic including:
Staphylococcus aureus, Clostridium difficile, Group B Streptococcus, Escherichia coli
Handled and prepare a variety of human specimens, including nasal swabs, vaginal swabs, fecal samples, and blood cultures.
Xenomics, Incorpoarted, Monmouth Junction, New Jersey (Trovagene, Inc. San Diego CA) – Research and Development
Scientist, Department of Product Development, April 2006-April 2007
Development of a Urine based Tuberculosis Molecular In Vitro Diagnostic (IVD) Test
Optimized quantitative PCR assays for Mycobacterium tuberculosis gene targets using Design of Experiment Strategies
Roche Molecular Systems, Branchburg, New Jersey - Operations
Senior Scientist, Department of Bioprocessing, October 2000-April 2006
Manufacture of DNA, RNA, and Bacteriophages as Controls for PCR In Vitro Diagnostic (IVD) Tests
Purification of DNA plasmid (~500 g) from E.coli via CsCl gradients and QIAGEN preparation
Purification of Bacteriophage and Phage-like particles via CsCl gradients and Size Exclusion Chromatography
Validation of Equipment, Processes, and Assays
Ensure compliance with GMP and FDA regulations by preparing validation protocols and final reports
IOQ, process, and assay validations
Process Development and Technology Transfer
Developed Plasmid DNA preparation using QIAGEN kits as a manufacturing process
Transferred process for Lambda Bacteriophage production from research and developed it as a manufacturing process
Improved existing processes and systems and prepared packages for change board approval
Technical Writing
Preparation of new Batch Production Records, Standard Operating Procedures, Quality Control Specifications, and Raw Material Specifications
Preparation of investigations reports and CAPAs for non-conforming products
Preparation of change control reports for change control approval
Fermentation of E. coli for Enzyme Purification
Batch Culture and Fed-Batch Culture Fermentation, followed by harvesting and pellet collection (typical pellet size 600g-1000g)
Sample analysis for enzyme identity, protein concentration, and enzymatic activity of DNA polymerases (specific activity of crude cell lysates)
Inventory Management
Manage inventory of newly manufactured products using the SAP management system
Schering-Plough Research Institute, Kenilworth, New Jersey – Research and Development
Scientist, Department of Antiviral Therapeutics, August 1999- October 2000 HCV Research: Focused on developing a stable cell line that propagates the HCV virus
Publications
Morrison J, Zweitzig DR, Riccardello NM, Axelband J, Sodowich BI, Kopnitsky MJ, O’Hara SM, Jeanmonod R. Retrospective Analysis of Clinical Data Associated with Patients Enrolled in a Molecular Diagnostic Feasbility Study Highlights the Potential Utility for Rapid Dectection of Bloodstream Infection. 2014. Am J. Emerg Med. 32(6):511-516.
Zweitzig DR, Riccardello NM, Morrison J, Rubino J, Axelband J, Jeanmonod R, Sodowich BI, Kopnitsky MJ, and O’Hara SM. Measurement of Microbial DNA Polymerase Activity Enables Detection and Growth Monitoring of Microbes from Clinical Blood Cultures PLoS ONE 2013 https://doi.org/10.1371/journal.pone.0078488
Sodowich BI, Zweitzig DR, Riccardello NM, and O’Hara SM. Feasibility study demonstrating that enzymatic template generation and amplification can be employed as a novel method for molecular antimicrobial susceptibility testing BMC Microbiol. 2013. 13:191
Zweitzig DR, Sodowich BI, Riccardello NM, and O’Hara SM. Feasibility of a Novel Approach for Rapid Detection of Simulated Bloodstream Infections via Enzymatic Template Generation and Amplification (ETGA) Mediated Measurement of Microbial DNA Polymerase Activity. 2013. J. Mol Diag.15(3):319-330.
Zweitzig DR, Riccardello NM, Sodowich BI, and O’Hara SM. Characterization of a Novel DNA Polymerase Activity Assay Enabling Sensitive, Quantitative, and Universal Detection of Viable Microbes. Nuc Acid Res. 2012, Vol. 40, No. 14 e109
Sodowich BI, Fadl I, and Burns C. 2007. Method Validation of in vitro RNA Transcript Analysis on the Agilent 2100 Bioanalyzer. Electrophoresis. 28(14):2368-2378.
Ingravallo P, Lahser F, Xia E, Sodowich B, Lai VC, Hong Z, and Zhong W. 2001.Characterization of Monoclonal Antibodies that Specifically Recognize the Palm Subdomain of Hepatitis C Virus Nonstructural Protein 5B Polymerase Virus Research. 75(2):179-187.
Abstracts
Sodowich BI, Enriquez E, Ishtiag G, Naik U, Patel J, and Aurora-Garg D. Feasibility Study of HEA BeadChip Genotyping with DNA Extract from Saliva Samples. SP269. Poster presented as part of the AABB Annual Meeting, Denver, CO., 12-15 October 2013. Abstract published in Transfusion 2013. Volume 53, No. 2S p. 161A.
O’hara SM, Sodowich BI, Zweitzig DR, Ricardello NM. Clinical Feasibility of a Rapid, Prescreen PCR Test for Candidate MRSA Colonized Patients using a Staphylococcus aureus (SA) real-time PCR assay. American Association of Clinical Chemistry, July 24-29, 2010, Anaheim, California.
O’hara SM, Zweitzig DR, Sodowich BI, Ricardello NM. Clinical Feasibility of a ToxB (tcdB) PCR Test for detection of Clostridium difficile from Loose Stool Samples in Patients Suspect of having Chlostridium difficile-associated Disease(CDAD.) American Association of Clinical Chemistry, July 24-29, 2010, Anaheim, California.
O’hara SM, Zweitzig DR, Ricardello NM, Sodowich BI. Development of a Rapid and Sensitive Group B Streptococcus (GBS) PCR Test that can be used to test Prepartum or Intrapartum Women. American Association of Clinical Chemistry, July 24-29, 2010, Anaheim, California.
Lahser F, Xia E, Lai VCH, Sodowich B, Lau JYN, and Hong Z. 2000. Evaluation of mammalian stable cell lines expressing HCV non-structural proteins. Antiviral Therapy. 5:(Suppl. 1) p. C.90.
Education
MS (1999) Rutgers University/Robert Wood Johnson Medical School, Piscataway, New Jersey. Joint Program in the Molecular Biosciences. Major: Pharmacology.
MS (1997) William Paterson College, Wayne, New Jersey. Major: Biotechnology.
BS (1993) Muhlenberg College, Allentown, Pennsylvania. Major: Biology. Minor: English.
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