Director of Operations, Boston VA Hospital, Jamaica Plain Campus (2012-Present)

Director of Operations for the Department of Veterans Affairs Central Biorepository located at the Massachusetts Veterans Epidemiology and Information Center (“MAVERIC”). Technical and scientific oversight of staff and laboratory processes.

Chief Consultant, BioRepCon, LLC., Fuquay Varina, NC. (2010-Present)

Consultation and client support for a wide range of services in laboratory operations and informatics. Providing written reports, plans, procedures, and other scope documents. On-site services including process design, development, and implementation. Informatics and LIMS design, development, and maintenance.

IT HCS Specialist, Perkin Elmer Corporation, Waltham, MA. (2010-2010)

Consultation and support for a large scale High Content Screening Platform, Linux (SUSE 9.0), laboratory information management system (LIMS), image management, and analysis platform. Performed installation and training for North America and parts of Europe.

Director, Biorepository, Feinstein Institute for Medical Research, Manhasset, NY. (1999-2010)

My role and responsibilities included the oversight and administration of all laboratory operations. As Director I managed the oversight for; all operations, all biological and chemistry development, staff development and management, all project management, financial budget and management, the sale of services strategy, SOP development, contract development and negotiation, business development of services, and approval and presentation of all proposals. In addition, I designed or approved all laboratory chemistries, sample processing, sample analysis and laboratory process and experiments including the design, development, and management of a laboratory robotics system created to support large-scale human genetic association studies. This state-of-the-art laboratory incorporates modular robotics, integrated laboratory data management system, and laboratory automation to process multiple different sample types including blood products, tissues, cells, and other human specimens as part of the clinical investigation. Lastly please review my skills summary which describes my role over the past 11 years in more detail.

Senior Lab Manager, Brown University, Providence, R.I. (1998-1999)

Division of Biology and Medicine, Dept. Pathology- Ex-vivo expansion of hematopoietic stem cells and subsequent genomic integration of a transposable element(TE). The TE constructs contain functional green fluorescent protein (GFP) fusion products as a way to study function using fluorescence confocal microscopy. Transformed cells were transplanted synergistically into mice in order to investigate cytoskeletal dynamics in platelet production In-Vivo.

Staff Scientist, Isis Pharmaceuticals, Carlsbad, CA. (1997-1998)

Department of Pharmacology- Development, and characterization of In-vivo and In-vitro cancer models to test anti-sense oligonucleotide therapeutic agents. Investigation of mechanisms governing tumor growth and inflammatory response. Xenograft model development for tumor reduction in SCID mice by targeted inhibition of tumor growth using anti-sense therapeutics.

Research Assistant, Silva Lab, Cold Spring Harbor Laboratory, Cold Spring Harbor, NY. (1993-1996)

Investigation of learning and memory deficits in CREB and NF1 mutant mice in order to understand mechanisms of synaptic plasticity. Investigation of the role of Activin on neocortical pyramidal neurons during development of rat embryo

Relevant Experience and Skill Set

Responsibilities

• Responsible for the overall operation and administration of the laboratory including: the employment of personnel; design and development of operations; design and implementation of safety policies, laboratory procedures and SOPs; design and implementation of quality control and assurance measures; financial revenue oversight and budget responsibility; and general project management;
• Oversight and determination of business process and strategies including: development of services; long-term strategic goals; contract development and negotiation; management and development of sale of services strategies; development, presentation, and / or approval of business presentations and proposals;
• Responsible for personnel oversight including: the assignment of duties based on qualifications; written performance appraisals; ensuring the orientation and adherence to policies and procedures; staff development and education; review and revision of position descriptions; encouraging and monitoring continuing education; oversight of in-house training programs; and selecting, placing, promoting, disciplining or terminating staff;
• Development of policies and procedures for the NSLIJHS Laboratory consistent with local and federal regulatory guidelines and standards including: the development of SOPs; QA/QC procedures and process; and Good Laboratory Practices;
• Development and management of NSLIJHS Laboratory specimen management system, inventory tracking system, laboratory instrumentation, and other enterprise data systems related to efficient laboratory processing;
• Design, development, and management / oversight of all biological and chemistry development including: chemistry development, validation, and testing; workflow analysis; robotic integration with various chemistries, platform development, or biological methods development;
• Financial management all Laboratory operations including: costing of all services, oversight of billing; project oversight; staff salaries; all budgets; and fiscal responsible for year over year success; and the design and development of a self-supporting revenue model;
• Oversight of laboratory process and experiments including the design, development and management of a laboratory robotics system created to support large-scale specimen processing;
• Design, development, and management of all specimen cold storage environments and associated tracking systems;
• Maintain extensive knowledge of processing multiple different sample types including: blood products, tissues, cells, and other biological specimens as part of research investigation;
• Providing consultations related to above duties and/or other knowledge with other staff members, senior staff members, laboratory clients, customers / clients, and other persons related to the operations of the Laboratory;
• Effective communication and interaction with accrediting, regulatory, administrative groups, and surrounding research and medical communities.

Accomplishments

• Establishment of the New York Cancer Project (chemistries, workflows, and LIMS), collection and testing of over 18,000 whole blood specimens, and the development of automated (robotic), design of laboratory processing, design of state-of-the art cold storage of samples, and sophisticated hit-picking operations for sample distribution; http://www.biorep.org/Library/Abstracts/ISBER2001.pdf;
• Establishment of the Laboratory as the National Lymphatic Disease and Lymphedema Registry. Both patient data and specimens collected, processed, and stored at the Laboratory – see http://lymphaticresearch.org/main.php?menu=research&content=patient-reg-new at the bottom of the webpage is a link – patients enter and manage their data, physicians validate the data, and researchers use the data. Assisted LRF with IRB approval and provided home IRB site;
• Successful implementation and establishment of the laboratory as an independent core after initial startup funding was exhausted including: fee for service sample collection and management; consultation services; kit creation services; specimen logistics and informatics support; and project management services;
• NIH/NIAID U19, Steve Hauser (PI), Gregersen (co-PI), 9/1/05 – 2/28/10, International MHC Genetics Network (IMAGEN), This project applied dense SNP mapping in the MHC to the analysis of several autoimmune disorders, including RA, SLE, MS, Myasthenia Gravis, and the MADGC families, among others. Approximately 10,000 patient DNA samples were be analyzed;
• Establishment of a completely independent wireless freezer and data center environmental monitoring system across 120 data collection points;
• Laboratory integration of an Autogen, Inc. nucleic acid purification robotic platform with LIMS and Tecan liquid handling workstations;
• Establishment of the Laboratory as the NIH General Clinical Research Center (GCRC) laboratory bringing the addition of 6 more specimen collection projects including the establishment and testing of new specimen processing methods for different disease modalities and tissue types;
• Establishment of the Laboratory as the specimen collection site for the Biogene Bank Patient Registry http://biogenebank.org/ including: the development of the website you are viewing, the development of new robotic system, assistance with data integration, assistance with collection site setup, and patient process workflows;
• Planning and construction of an energy and money saving minus eighty (-80) walk-in freezer with multiple redundancy (multi-loop) compressors. The system provides the equivalent space of (35) upright (25) cu.ft. freezers;
• Successfully passed in-house and external audits from several different agencies (high marks all occasions).

Chao Tian, Robert M. Plenge, Michael Ransom, Annette Lee, Pablo Villoslada, Carlo Selmi, Lars Klareskog, Ann Pulver, Lihong Qi, Peter K. Gregersen, Michael F. Seldin (2008) “Analysis and Application of European Genetic Substructure Using 300 K SNP Information”, Acknowledgment (Robert Lundsten for biorepository services and data management), PLOS Genetics, Jan 4, 2008, Volume 4, Issue #1.

Henrik Källberg, Leonid Padyukov, Robert M. Plenge, Johan Rönnelid, Peter K. Gregersen, Annette H. M. van der Helm-van Mil, Rene E. M. Toes, Tom W. Huizinga, Lars Klareskog, Lars Alfredsson, and Epidemiological Investigation of Rheumatoid Arthritis (EIRA) Study Group (2007) “Gene-Gene and Gene-Environment Interactions Involving HLA-DRB1, PTPN22, and Smoking in Two Subsets of Rheumatoid Arthritis” Acknowledgment (Robert Lundsten for biorepository services and data management), Am J Hum Genet. 2007 May; 80(5): 867–875.

Chris I Amos, Wei V Chen, Annette T Lee, Wentian Li, Marlena Kern, Robert Lundsten, Franak Batliwalla, Mark Wener, Elaine Remmers, Daniel A Kastner, Lindsey A Criswell, Michael F Seldin, Peter K Gregersen (2006), “High-density SNP analysis of 642 caucasian families with rheumatoid arthritis identifies two new linkage regions on 11p12 and 2q33”, Genes and Immunity, 7(4):277-286.

N Matsuoka, Patki, HK. Tiwari, SB Johnson, PK Gregersen, RL Liebel, and WK Chung (2006) “Association of K121q Polymorphism in ENPP1 (PC-1) with BMI in Caucasian and African-American adults”, Acknowledgment (Robert Lundsten for lab work and data analysis), Nature Publishing Group – The International Journal of Obesity 30: 233-237

Damini Jawaheer, Wentian Li, Robert R. Graham, Wei Chen, Aarti Damle, Xiangli Xiao, Joanita Monteiro, Houman Khalili, Annette Lee, Robert Lundsten, Ann Begovich, Teodorica Bugawan, Henry Erlich, James T. Elder, Lindsey A. Criswell, Michael F. Seldin, Christopher I. Amos, Timothy W. Behrens, and Peter K. Gregersen (2002) “Dissecting the Genetic Complexity of the Association between Human Leukocyte Antigens and Rheumatoid Arthritis”, American Journal Human Genetics 71:585­594

Robert Lundsten, Houman Khalili, Theodore E. Mifflin, Brendan Sean Graves, James Gunderson, Robin A. Felder, Peter K. Gregersen (2001) Automation of the New York Cancer Project Laboratory, Abstract, International Society of Biological and Environmental Repositories (ISBER), Biotechnic & Histochemistry

TE Mifflin, BS Graves, J Gunderson, G Wasson, S Kell, S Geddy, C Piche, R Lundsten, H Khalili, PK Gregersen, RA Felder (2001) Design and Development Of A Large Scale Automated Laboratory For Robotic Storage and Archival Of Human Genomic Samples, Abstract, Association for Laboratory Automation Meeting 2001.

L. Bearer, Z. Li, R. Lundsten and K. Matsutani (1998) Dynamics of ARP2 and 2E4 in Megakaryocytes. Abstract, 38th meeting of ASCB/Molecular Biology of the Cell.

Silva, A.J., Fedorov, N., Kogan, J., Frankland, P., Coblentz, J., Lundsten, R., Friedman, E., Smith, A., Cho, Y., and Griese, K.P. (1996) Genetic Analysis of Function and Dysfunction in the central nervous system. Symposia on Quantitative Biology, Vol. LXI, Cold Spring Harbor Press.

Nikolai B. Fedorov, Robert A. Lundsten, Tyler Jacks and Alcino J. Silva. (1996) Impairment of hippocampal CA1 synaptic transmission in NF1 mutant mice. Function and Dysfunction in the nervous system, Abstract, Symposia on Quantitative Biology, Vol. LXI, CSHL, N.Y.

Lundsten, R., Nawa, H. (1996) Effects of Activin on neocortical pyramidal neurons during development of rat embryo. CSHL Annual Report.

Nawa, H., Mizuno, K., Carnahan, J., Lundsten, R. (1995) Neurotrophins and Activin positively and negatively regulate expression of synaptic molecules. Abstract 4th IBRO World Congress of Neuroscience, Kyoto, Japan.

Mizuno, K., Carnahan, J., and Nawa, H. (1994) Brain-Derived Neurotrophic Factor promotes differentiation of striatal GABAergic neurons. Acknowledgment in Dev. Bio…165, 243-256.

BioIT World 2009, World Trade Center, Boston, MA. Invited Keynote Speaker, Service Oriented Architecture and Laboratory Data Integration.

Biobanking 2009, Philadelphia, PA., Jan 12 to 15, Invited Panel Participant and Speaker, Joining the Dialogue on Industry – Academia Collaborations – Building Up the Missing Link to Leverage Biobanking Resources And Accelerate Drug Discovery – Successfully navigating a Laboratory audit.

2006 ISBER Meeting, Bethesda, MD., Automated Processing of Human Specimens at the North Shore Long Island Jewish Health System Laboratory.

2005 Long Island Technology Hall Fame, Innovation acceptance award for automated (robotic) laboratory.

2003 ISBER Meeting, Philadelphia, PA. Laboratory Information Management.

2001 ISBER Meeting, Decatur, GA. Automation of the New York Cancer Project Laboratory (NYCPB).