Stephan K. Owens, MS

Phone: 914-***-**** Email: adt9lu@r.postjobfree.com / adt9lu@r.postjobfree.com/

Summary of Qualifications:

Experienced scientist and laboratory supervisor with a background in both translation and clinical research. Excellent in various computer programs and clinical databases such as: REDCap, VitalAxis (LIMS), Cerner (LIMS), DaViD (LIS) and Electronic Document Management Systems (EDMS) and REES. Expert in protocol management/monitoring experience, evaluation and ensuring integrity of study data and following study timelines in accordance with SOPs. Pharmaceutical experience with a wide range of companies. Expertise in clinical procedures and laboratory techniques. Adept at quickly learning and applying new concepts, techniques, and procedures. Extensive skills in leadership, organization, management, and communication. Proven ability to organize, prioritize and assist with multiple projects

Technical Skills:

Laboratory: Animal handling, tissue culture, PCR/RT-PCR/single cell PCR, SDS-PAGE, Flow Cytometry, gel electrophoresis, media and reagent preparation, ELISA, ELIspot, DNA/RNA/protein extraction, isolation, and purification, Western blot, magnetic cell sorting, PBMC preparation, bacteria plating, HPLC. Neurobehavioral Research. Biohazard Waste Management. BSL-2, BSL-3

Clinical: Phlebotomy, EMS experience, specimen procurement, processed human cord blood samples BLS, vital stats and signs. SOP’s, safety reports. Logistics. EDMS (doc control). LIMS, LIS, and Citrix software. NEAR4KIDS

Computer: Mac OS X, Windows, FlowJo, MS Word/Excel/PowerPoint, GraphPad Prism, SigmaPlot, Oracle PeopleSoft Enterprise, general web skills (IE/Safari/Chrome).

Education:

Bachelor of Science, Biology – 2015

New York Institute of Technology, Old Westbury, NY

Master of Science, Bioinformatics – 2020

Johns Hopkins University, Baltimore, MD

Professional Experience:

Clinical Lab Supervisor Oct 2022 to Present

Shield T3, LLC

Washington, DC

Duties include:

Ensuring environmental monitoring of lab and patient samples ensuring accuracy in patient results. Testing and monitoring contamination

Responsible for quality control of data in regards of compliance with regulatory requirements of various protocols and CLIA/ CAP protocols

Development and implementation of SOPs.

Execute training consistent with the requirement of repeatability, minimizing risk of error that could threaten patient results, lab safety or organization reputation.

Ensuring direct report comply with BLS-2 working procedures and standards

Directly supervise, train and mentor laboratory testing staff. Clearly communicate expectations to staff and evaluate individual employee performance

Monitor daily workflow in the lab, plan / schedule for adequate assay coverage, and troubleshoot / escalate problems, as necessary

Build and sustain collaborative relationships with individuals in different disciplines and serve as subject-matter expert for research teams and collaborators.

Accomplishments: Leading a team of 20+ MLT/CLS combating the pandemic

QC Analyst III (lead) Aug 2022 to October 2022

IDT Biologika Corporation

Rockville, MD

Duties include:

Perform routing and dynamic environmental monitoring (EM) consisting of non-viable particulates (NVP), viable air (VP) and viable surface (VS) testing.

Perform various microbiological and chemical laboratory test for EM, utility, and investigational samples

Perform investigations and address corrective and preventive actions internal or external audit findings

Maintain compliance with GMP and GLP guidelines

Expert on variety of assays

Accomplishments: Leading a team and helping create a more robust quality system for our corporation

Clinical Lab Supervisor Apr 2021 to Sep 2022

Opentrons Labworks, LLC/PRL

Rockville, MD

Duties include:

Ensuring environmental monitoring of lab and patient samples ensuring accuracy in patient results. Testing contamination

Responsible for quality control of data in regards of compliance with regulatory requirements of various protocols and CLIA/ CAP protocols

Monitoring clinical clients, interpreting/identifying data and ensuring results are conducted in a timely manner.

Development and implementation of SOPs.

Directly supervise, train and mentor laboratory testing staff. Clearly communicate expectations to staff and evaluate individual employee performance

Monitor daily workflow in the lab, plan / schedule for adequate assay coverage, and troubleshoot / escalate problems, as necessary

Clinical data curation and integration

Validating and testing new bioassays such as ELISA

Develop, input, and maintain databases, trackers, and documentation for the lab.

COVID, Influenza A/B, and RSV.

Accomplishments: Leading a team of 20+ MLT/CLS combating the pandemic

Associate Scientist 2020 to 2022

NIH/NIAID – Vaccine Research Center (VRC) – Vaccine Production Program (VPP)

Gaithersburg, Maryland

Contractor: Medical Science & Computing, Inc

Duties include:

Manage and provide oversight for scientific and regulatory-supporting documentation systems for a diverse group of scientist and administrative staff.

Supports clinical staff develop, implement, and maintain clinical research data files and materials.

Development and implementation of SOPs and bioassay development

Coordinate with multidisciplinary teams to execute clinical trials for various infectious disease studies.

Support team collaborations with internal and external stakeholders, including communication of trial information, data, and shipment of biological samples.

Liaise with VPP, VRC and external stakeholder personnel on receipt and distribution of materials in accordance with EDMS.

Manage a study tracking system and create detailed spreadsheets used to keep track of study objectives and timelines.

Manage purified bulk vaccine candidates/biotherapeutics or bioreagents from the VPP downstream group.

Oversee coordination and systems development for transfer product administration information to clinicians for clinical trial use, as well as product quality monitoring during clinical trial duration.

Provides oversight compliance identifying/reporting any issues, findings, while ensuring no deviations from SOPs, NIH and Federal guidelines.

Follow established departmental policies, procedures, and objectives, continuous quality, improvement quality and safety, environmental and/or infection control standards.

Provide a wide range of advanced statistical expertise, guidance, and support to researchers, scientists, clinicians, and managers engaged in research studies within the NIH. Participate in the design, development, and reporting of research studies and clinical trials. Collect, analyze and interpret biological and health science data across multiple research programs. Respond to a broad range of complex statistical issues arising in a variety of clinical and biomedical research settings.

Accomplishments: Contributed to all VRC functions as well as founded the DEIC

Laboratory Technician/Clinical Assistant 2019 – 2020

Generation Next Fertility

New York, NY

Duties include:

Performed research-based data analysis on ART techniques (pregnancy outcome)

Maintained Fertility lab (Endocrinology, Hematology).

Performed daily/monthly quality control procedures for media and equipment

Oocyte retrievals, daily plan preparation for all patients, chart rotations

Accomplishments: Consider adding any accomplishments you’ve had

Laboratory Technician 2017 – 2019

Columbia University, Irving Medical Center

New York, NY

Duties include:

Performed behavioral test in mouse models with neurological disorders

Analyze and organize data, manage animal breeding for different investigators, harvest tissues.

Trained clients in animal behavioral assays who used our core facility for research.

Troubleshooted various equipment and assisted on various research protocols

Accomplishments: Collaborated with several departments within CUMC and contributed to published work.

Research Assistant 2016 – 2017

Western Michigan University, Homer Stryker MD School of Medicine

Kalamazoo, MI

Duties include:

Created/ modified protocols for the Center of Immunobiology

Managed lab operations and personnel

Collaborated with investigators to develop and perform experiments involving B1 cell development and function in various animal models and patient samples

Negotiated contracts with vendors

Performed Elisa, Western blotting, Cell Culture, and various techniques for experimental projects

Developed and tested immune-bioassays, cell based assays (cell death, proliferations, viabilities studies)

Accomplishments: Assisted with the establishment of the first research lab within the medical school.

Emergency Medical Technician 2015 – 2016

Empress EMS

Yonkers, NY

Duties include:

Delivered basic life support and advanced life support in treating patients.

First Responder to emergency and non-emergency calls.

Interpret limited histories and examine whether patients to identify underlying critical conditions.

Accomplishments: Provided EMS support to the Tri-State area.

Research Assistant 2014 – 2016

Feinstein Institute of Medical Research

Manhasset, NY

Duties include:

Performed protein extractions, western blot, PCR, and various other techniques

Contributed to research lab operations and equipment

Conducted experiments involving processing of human blood and cord blood to analyze lymphocytes.

Performed Elisa, Western blotting, Cell Culture, HPLC and various techniques for experimental projects and various bioassays

Accomplishments: Contributed to B1 and ribosomal protein Haploinsufficiency research.

Research:

S. Singh, S. Owens, and T. Rothstein. Ribosomal proteins possess p53-independent tumor suppressor function Poster presentation, NIH future Research Leaders Conference, September 2015

Oral Presentation:

Mouse models of neurodevelopmental disorders. Biomedical Research Awareness Day (B.R.A.D). Columbia University Medical Center. New York. April 17, 2018.

Volunteer Experience:

Eastchester Volunteer Ambulance Corps (EMT) 2014-2016

Science Pathfinders Program (MIM), Teacher 2014-2017

White Plains Parks & Recreation (XC/Track Coach) 2014-2019

Mentoring in Medicine, Montefiore Medical Center, Mentee 2012- 2022

Weil Cornell Medicine, New York Presbyterian Hospital, PCIU 2018- 2022

NIH/NIAID-VRC DEIC Committee-Founding Co-Chair 2020- 2022

Extracurricular Activities:

Intervarsity Christian Club NYIT (Secretary) 2011-2013

American Red Cross Club NYIT (Member) 2011-2014

Biomedical Research Society NYIT (Vice President) 2012-2014

References:

Excellent personal and professional references available upon request.

Pending Publications:

Dugger SA, Dhindsa D, Halvorsen M, Owens S, Ozuruonye E, Montero G, Sah M, Colombo S, Petri S, Yang M, Frankel W, Boland M, Goldstein D. Transcriptomic effects and neurological phenotypes in a mouse model of HNRNPU haploinsufficiency. Society for Neuroscience (SfN) Annual Meeting. San Diego, 2018.

Amador A, Kanber A, Ozuruonye E, Owens S, Peters J, Olson H, Poduri H, Boland M, Goldstein, Traynelis SF, Yuan H, Frankel WN, Yang M. Mice with heterozygous missense mutation of Grin2a exhibit developmental delay, hyper-activity, learning deficits. Society for Neuroscience (SfN) Annual Meeting. San Diego, 2018.

Yang M, Colombo S, Ozuruonye E, Owens S, Petri S, Montero G, Michael Boland M, Frankel W, Goldstein D. Mice with a heterozygous missense mutation in Gnb1 (Gnb1K78R/+) exhibit developmental delay, hypoactivity, gait abnormality, and deficits in spatial learning. Society for Neuroscience (SfN) Annual Meeting. San Diego, 2018.

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