QUALIFICATIONS: I am driven, detail oriented and quick to learn new processes. My last role ended due to a company restructure but I left on good terms and received a severance package. I am local and can interview with a 24-48 hours’ notice. Thanks in advance for your consideration.

Robert Bruce

KEY ACCOMPLISHMENTS:

In the EU, IVD manufacturers must now submit to a notified body review of technical documentation. Under IVDD, only a small percentage of devices had regulatory oversight while the rest were self-certified. With the implementation of IVDR, the majority of manufacturers must now submit to technical documentation review by a notified body. My contribution to this was the generation of reports demonstrating the clinical utility and state of the art assessments of Abbott assays for ARCHTECT and Alinity.

Implemented multiple liquid handling platforms at Celera and Abbott Tecan, Packard, Abbott m-2000sp)

Practiced “Servant Leadership” which means encouraging diversity of thought, creating a culture of trust, having an unselfish mindset, and fostering leadership in others.

Developed novel dye terminator sequencing kit and filed record of invention.

Received 4 DNA Awards (company award for excellence) for achievements at Celera.

Achieved internal recognition in broad area of expertise (sequencing chemistry, real-time PCR, DNA, RNA extractions, in vitro transcription, and HIV genotyping analysis), at Celera, Genomic Health and LLNL.

Served as developmental lead on improvements to Celera’s flagship products, the ViroSeq HIV-1 genotyping system, and the Integrase Genotyping assay. In the case of ViroSeq, work was submitted as a 510(k), (number BK080026, Regulation Number 866 3950. Submitted 06/11/2008) cleared 07/10/2008) demonstrating that the assay was substantially equivalent to the existing Viro Seq kit then on the market.

Developed multiplex ELISA assay for early detection of lung cancer on Luminex platform; resultant prototype assay exhibited superior performance to aptamer-based assay developed by another group.

Performed initial feasibility studies to determine the potential of isothermal loop-mediated amplification (RT-LAMP) as way of monitoring viral loads in HIV positive patients in areas of limited resources.

EDUCATION:

University Chicago, Chicago, IL

Bachelor of Science in Biology

University of Illinois at Urbana-Champaign, Champaign, IL

Master of Science in Biochemistry

PERSONAL EXPERIENCE:

Abbott Diagnostics, Conway Park, IL

December 2018 – January 2023

Scientific Affairs Senior Specialist 2020 – 2023

Partnered in support of the In Vitro Diagnostic Medical Device Regulation (IVDR).

Researched clinical studies relating to use of Abbott instrumentation and reagents in a clinical setting, and assessing Abbott products as being state of the art.

Reviewed reference safety information tracking any adverse effect to patient outcomes in the field as the result of an Abbott assay, as part of the IVDR project.

Reviewed medical and scientific information for over 200 Abbott products covering Oncology, Immunology, Cardiovascular, Liver, Kidney, Thyroid, and Infectious Disease therapeutic areas and ensured that medical and scientific information is of high quality and communicated in an accurate, balanced, timely and compliant way.

Reviewed Scientific Literature, wrote abstracts and summary report for Scientific Validity, State of the Art, and Clinical Utility for IVDR and Global PMS updates to Abbott’s on- Market Products. Follow up monthly literature review of products.

Performed proofreading, editing, document formatting, review comment integration and document completion / approval activities.

Reviewed reports with colleagues in cross-functional team meetings.

Management of references was performed using Distiller, a systematic review software. Reports were managed using Share Point collaboration software. Additional literature searches to support regulatory submissions were performed as required.

Reviewed and approved Design Input review, Design Plan, Instruction for Use (for Control, calibrators, and reagent Inserts), Product risk classification, Scientific Validity Report, State of the Art, Product Requirement Document, Performance Evaluation plan, Performance Evaluation Report and Post Market Performance Follow Up Report and Post market surveillance report.

Collaborated with internal stakeholders in multiple functional areas (Regulatory, Quality, Technical, Scientific, Risk Management, and Marketing) to draft operating procedures needed to comply with the regulations and to evaluate various opportunities to address medical needs.

Explained complex medical issues to non-medical personnel.

Provided Medical/Scientific Input to assays to ensure product safety and effectiveness for patients and users.

Regulatory Affairs Associate 2018 – 2019

Implemented and maintained effectiveness of the quality system. Reviewed medical complaints, document filing decision rationale, and submit medical event reports in compliance with FDA regulations (21CFR803 and 21CFR820) and International Regulatory requirements within the required timeframes.

Ensured medical event file documentation is clear, concise, and adheres to compliance requirements.

Identified nonconformances or potential nonconformances in a timely manner, ensured thorough documentation, and aided in development of comprehensive CAPA strategies to prevent recurrence.

Used Abbott quality system management tools such as Pilgrim Smart Solve for procedures and training, APLM (Abbott Product Lifecycle Management System) Thin Client Database for design records and Track Wise for CAPAs.

Provided subject matter expertise to Customer Service and Support and Quality organizations identifying and resolving potential medical, clinical and safety issues.

Analyzed and documented data using Excel, EDMS, and E-Novator.

Abbott Molecular, Des Plaines, IL

June 2015 – November 2018

Senior Scientist

Performed CAPA investigations, determining root cause of product nonconformances of IVD products. Collaborated with outside vendors on reagents to be used in Abbott assays. Ran multiple assays on m-2000 system, a specialized liquid handling platform.

Oversaw written protocols, lab writeups, and reports related to investigations of product nonconformance for IVD products.

Implemented experiments in support of laboratory investigations of product nonconformance.

Served as technical lead in transfer of ViroSeq HIV-1 Drug Resistance Genotyping (IVD) and the companion Integrase Genotyping assays to Abbott from Celera.

Recognized as resident SME for Abbott’s ViroSeq HIV-1 Drug Resistance Genotyping (IVD) and the companion Integrase Genotyping assays acquired from Celera Diagnostics in 2015.

Functioned as main contact in charge of ViroSeq laboratory, ensuring all instrumentation in compliance in accordance with design control.

Interacted with cross-functional teams, including personnel from sales, supply chain, regulatory, quality control, and manufacturing.

Successful completion of the project resulted in product being in inventory before old inventory exhausted; both products contributed over $10 million to Abbott annually.

Celera Diagnostics, Alameda, CA

April 2004 – July 2014

Scientist

Designed prototype assay detecting and typing Human Papillomavirus (HPV), utilizing combination of PCR and single base DNA sequencing. Served as laboratory manager running daily operations of development lab.

Presented posters at several scientific meetings, collaborating with potential customers and answering questions about products.

Served as developmental lead on improvements to company’s flagship product, the ViroSeq HIV-1 genotyping system (IVD), including reformulation of sequencing chemistry used in the assay. Wrote protocols, reports and conducted studies, looking at factors like dilution studies to determine optimum concentrations of reagents, conducting isochronous stability studies, accuracy and sensitivity studies, and freeze thaw studies. The result was a kit in which costs were reduced by 75% without any effect on performance; development of a post-PCR cleanup protocol; replacement of spin columns with Exo I and Shrimp Alkaline Phosphatase, resulting in a cost savings of 25%; and consumer approval of the change, resulting in improved sales.

Developed new PCR cycling protocol for companion Integrase assay incorporating the use of heat labile UNG, resulting in a more streamlined cycling program.

Developed large-scale nucleic acid extractions using specialized liquid handling platform.

Organized training on new NGS instruments and maintained $1 million of lab equipment in validation for use in design control studies.

Evaluated and participated in the implementation of NGS platforms (PGM, MiSeq, MiSeqDx): and conducted proof-of-concept experiments.

Gained experience on 21 CFR Part 820 quality system regulations.

Mentored newly hired PhDs on company projects.

Functioned as development lead for new version of flagship of IVD HIV-1 Drug Resistance genotyping assay. Submitted results as part of 510(k) submission to FDA.

Performed designed controlled studies with newly developed primers for HLA typing as part of submission for CE clearance in Europe, resulting in poster presented at 39th annual ASHI Conference in Chicago in 2013.

Evaluated new software for use with HLA product line, finding it easier to use, and proposed implementation; consumer acceptance of change resulted in greater sales of kits by 10%.

Completed testing on 100 primers for expanded HLA kit, which resulted in additional primer sets offered to customers as new products.

Built database of 140 DNA samples used in lab for HLA testing involving Class I and II HLA typing.

Created series of experiments developing and optimizing assay to preferentially detect oncogenic HPVs at levels below 200 copies/ML, leading to presentation of four posters in first year and collaborations with Abbott and LabCorp.

Partnered with Johns Hopkins on projects related to improvements in existing products; work resulted in several publications.

Aided team developing new KIF6 and HCV real-time PCR Viral Load Test. Utilized Qiagen and M2000 robotic workstations to isolate DNA from patient samples and amplify via real-time PCR.

Developed multiplex ELISA assay for early detection of lung cancer on Luminex platform; resultant prototype assay exhibited superior performance to alternative assay developed in another group. Work resulted in publication and transfer of the ELISA assay to Quest Diagnostics after the closing of Celera.

Created high-purity plasmids for use in quality control, resulting in significant savings by eliminating outside vendor.

Created high-purity full-length RNA transcript for Integrase gene, resulting in time and cost savings for quality control, avoiding time-consuming and expensive process of isolating viral RNA for use in RT-PCR assays.

Oversaw development of prototype assay for avian flu (H5N1).

Directed implementation of assay for KIF6 (marker strongly associated with coronary heart disease) in clinical laboratory. Identified errors in implementation of assay and corrected process, resulting in on-time delivery of results to patients.

CERTIFICATIONS:

Regulatory Affairs Professional Association

AQR-CAPA Initiator Evaluator, 2016

AQR-CAPA Investigator, 2016

AQR-CAPA Resolution Planner, 2016

Confidential Information, 2016

BSL Level 2, 2005

PROFESSIONAL DEVELOPMENT:

JMP 12, 2017

DOE, 2017

ABTRAQ Record Basics and Navigation, 2017

ABTRAQ Desktop Basics and Navigation, 2017

Introduction to the CAPA Process, 2016

CAPA Initiation/Evaluation Simulation Workshop, 2016

CAPA Investigation Simulation Workshop, 2016

CAPA Resolution Planner Simulation Workshop, 2016

Hazard Communication/GHS CBT, 2015

PROFESSIONAL MEMBERSHIPS:

Regulatory Affairs Professional Society

TECHNICAL SKILLS:

MS Office Suite, PC and Mac Platforms, Ultracentrifuges, Fluorometers, Spectrophotometers, Densitometers, Capillary Sequencers, NGS Platforms, Gel Electrophoresis Apparatus, Thermocyclers, Scanners, Luminex 200 System, Real-Time PCR, NanoDrop, Agilent Bioanalyzer, Pyrosequencing, RNA Sequencing, HLA Typing, Millipore Water Systems, pH Meters

PUBLICATIONS:

Blood-based lung cancer biomarkers identified through proteomic discovery in cancer tissues, cell lines and conditioned medium.

Birse CE, Lagier RJ, FitzHugh W, Pass HI, Rom WN, Edell ES, Bungum AO, Maldonado F, Jett JR, Mesri M, Sult E, Joseloff E, Li A, Heidbrink J, Dhariwal G, Danis C, Tomic JL, Bruce RJ, Moore PA, He T, Lewis ME, Ruben SM.

Clin Proteomics 2015 Jul 16, 12(1):18

Analysis of HIV Type 1 gp41 Sequences in Diverse HIV Type 1 Strains.

SH Eshleman, SE Hudelson, R Bruce,T Lee,MR Owens, J Hackett,P Swanson, SG Devare, N Marlowe,SH Eshleman, SE Hudelson,R Bruce, T Lee, MR Owens, J Hackett, P Swanson, SG Devare, N Marlowe

AIDS Res Hum Retroviruses. 2007 Dec; 23(12):1593-8

Analysis of HIV Type 1 gp41 and Enfuvirtide Susceptibility among Men in the United States Who Were HIV Infected Prior to Availability of HIV Entry Inhibitors

Sarah E. Hudelson, Natalia Marlowe, Wei Huang, Robert Bruce, Jessica D. Church, Marla Husnik, Deborah Donnell, Thomas Coates, J. Brooks Jackson, Margaret Chesney, Beryl Koblin, Susan H. Eshleman

AIDS Research and Human Retroviruses. July 2009, 25(7): 701-705.

Contact this candidate