Business Development Computer System

Edward Francis O’Connor, PhD

Contact Information:

** ******* *****, ********, ** 06078-1533

Cell: 860-***-****

Email: *********@*****.***

Professional Summary:

Experienced scientist with a robust background in budgeting, scheduling, program, project and personnel management, conflict resolution, and mentoring. Proficient in applying in silico software to predict physicochemical properties, fragmentation, and chromatography of new compounds.

Expertise in QA assessment and auditing of protocols, reports, methods, and SOPs supporting GLP and GMP standards and use of Veeva and Trackwise for change control, document and data integrity, LIR and CAPAs. Strong skills in translational science, method transfer, outsourcing, and analytical and bioanalytical method development, validation, application, and interpretation. Proficient in LC-MS, UV, FL, LS, EC, CL, ligand binding, and cell-based assays. Experienced in computer system qualification (URS, UAT, DRS supporting IQOQPQ. Adept at business development support and data analysis for CMC, Tox, PK/PD for IND, NDA, ATA, ADA, and BLA submissions using eCTD. Comprehensive knowledge of FDA, EMA, ICH Guidance, 21CFR58, 21CFR11, 210, 211, 820,

21CFR320, 50, 54 (GLP, GMP, BA/BE, GCP), ISO 9001, 17025, and HIPAA.

Notable Achievements:

Pioneered the first validation of a semi-quantitative microbiological assay.

Developed and validated an ATA assay format for quantitation of cut point equivalents in ng/mL.

Created and validated LC-UV methods for the measurement of antisense oligomers in serum and lecithin-based liposome.

Achieved the first validation of a quantitative assay for an RNA aptamer to VEGF using dual hybridization and chemiluminescence detection.

Implemented the selection of an LC-MS/MS to support intact large molecule (antibody) quantitative analysis.

Established bacterial identification in product release samples using MIDI.

Consulting and Professional Experience:

Alexion, New Haven, CT

GMP QA Manager IV (Jun 2023 - May 2024)

Managed deviations, LIR, CAPA transfer, protocol, and report preparation for large molecules. Trained in Veeva and Trackwise for QMS. Problem solving, Fishbone, 5 why. LC-MS, UV, ELISA-VIS. Review of external PQs, CoAs, CoT, Vendor Management. Program and project management. Process validation.

Vertex, Boston Seaport, MA

GMP QA Manager (May 2022-Feb 2024)

Managed, edited and approved deviations, LIR and CAPAs. Change control using Veeva. Outsourced method transfers, used Veeva for training and QMS. Power point and Excel for summarizing assay failures. Reviewed transfer SOPs with editing to ensure success. IR, KM, LC-Ms, ELISA-VIS. Problem solving, Fishbone, 5 Why. Review of external and internal IQOQPQ, SOPs. Process validation.

AAVANTI BIO, Cambridge, MA

Development and Validation Specialist (Nov 2021 - Apr 2022)

Supported AAV9 delivery of mRNA and managed large molecules. Outsourcing and ensuring method met GMP and GLP requirements (vendor management). Statistical evaluations using Prism and Minitab. LC-MS, ELISA-VIS, CBA. Vendor management. Process validation,

Mitsubishi, Jersey City, NJ

Development and Regulatory Specialist (May 2021 - Jul 2021)

Focused on cell-based assays for small and large molecules to meet regulatory requirements. CBA, ELISA-VIS. Protocol and SOP development.

AIT, Indianapolis, IN

Method Development and Validation Specialist (Jun 2020 - Apr 2021).

Improved methods re acceptance criteria and efficiencies in GLP CRO space. Did both program and project management including scheduling and resource allocation. Supported large and small molecule analysis. LC-MS, LC-UV, CBA, ELISA-VIS, Computer system validation review. Protocol, amendment and deviation CAPA, LIR and SOP development. Problem Solving using 5why and fishbone.

Dicerna, Cambridge, MA.

GLP/GMP Specialist (May 2020 - Oct 2020)

Developed SOPs and statistical analyses for large molecules to ensure GLP, GMP and GCP regulatory compliance. LOC-Ms, ELISA-VIS. Review of Computer system validation.

Thermo (Brammer), Cambridge, MA Validation Specialist (Jan 2020 - Feb 2020)

Validated USP 85 for medical devices and small molecules, developed Brammer (Now Thermo) SOPs to meet GMP requirements. ELISA-Vis. Review of SpectraMax and SMP IQ, OQ, PQ. Computer system validation, validation of Endotoxin, SOP development for same.

Aprogen, ChongJu, Korea

Inspection Readiness Auditor (Dec 2019 - Jan 2020)

Provided recommendations for analytical and bioanalytical support laboratories in GMP space to ensure Aprogen would meet and exceed GMP inspections. LC-MS, ELISA-VIS, Analyst, SoftMax Pro and related Computer System Validation.

Uniqure, Lexington, MA

GMP Auditor (Nov 2019 - Dec 2019)

Audit resulted in several assay improvements capturing efficiencies in SOPs and methods supporting product release. LC-MS, ELISA-VIS.

VenatoRx, Malvern, PA.

GLP Specialist (Apr 2019- Aug 2019)

Focused on small molecule analysis. SOP review and editing, problem solving using Fishbone and 5 Why. ELISA-ViS. Method development, Validation and transfer.

DuPont, Madision, WI.

Instrument Validation SME (Mar 2019-Apr2019

GMP Validation of Processing Equipment, SOPs, and protocols for method validation, computer System validation and review for metal particle detection in flowing material stream.

Smithers Avanza, Gaithersburg, MD GLP Specialist (Jan 2019 - Mar 2019)

Provided Validation QA supporting internal decommissioning and revalidation of equipment and software supporting two relocations (IQOQPQ) ELISA-VIS, FL, CI, CBA, MSD.

ICON Labs, Whitesboro, NY

GLP Specialist (Aug 2018 - Dec 2018)

Reviewed GLP, GCP results for small and large molecules. Provided lab design including addition of cell-based assays to ICON labs offering. LC-MS, ELISA-VIS, MSD, CBA. FDA, EMA Guidance.

W.L.Gore, Prescott, AZ.

GMP SoftMax Pro SME (Apr2018-May 2018)

Validation of SpectraMax and SoftMax Pro for GMP product release, Computer system validation of SpectraMax and SMP (IQOQPQ, URS, DRS, UAT).

Smithers Avanza, Gaithersburg, MD

Contractor GLP assays and Software (Jan 2017 to May 2017)

GLP software auditor and validation re SoftMax Pro, Watson and “black box” calculations. Discovered and reported on Watson calculation and deficiencies. Taught GCP overview for bioanalytical support staff, including history and responsibilities of staff including HIPAA. Validated Watson, SoftMax Pro and Excel. ELISA-VIS

Lovelace Bioanalytical, Alburquerque NM.

Associate Director Bioanalytical (DEC 2015-JAN 2017)

Directed large and small molecule labs to meet FDA, EMA and USP guidance. Managed and scheduled resources to meet sponsors demand. LC-MS and ELISA VIS, FL, CL equipment with analyst (LC-MS) or SoftMax Pro (ELISA), respectively. Validation (IQOQPQ, URS, UAT, DRS) of TECAN Freedom EVO, Eppendorf epMotion and TomTec automation. Use of EliSpot and BD Flow Cytometer, SOPs and Validation of same.

Aegisbioconsult, Suffield, CT Consultant (Aug 2015 - Dec 2015)

Provided training on technical, statistical, and compliance issues for regulated bioanalysis. LC-MS, LC-UV, MSD, ELISA

Alexion, Cheshire Ct

Senior Manager of Bioanalytical Outsourcing and Laboratory Operations (Jul 2014 - Aug 2015)

Identified and vetted CROs to support multiple GLP/GCP and CLIA projects, managed 15 projects at 7 CROs, supported clinical and non-clinical projects, mentored staff on HIPAA and contributed to pharmacovigilance and safety issues. Program and project management using MS Project. ELISA- VIS, FL. CBA, Hemolytic assays. Designed Bioanalytical Lab at 100 College Street, New Haven. Manageed outsourcinbg of non-clinical and clinical testing.

Frontage Labs, Exton PA

Executive Director of Bioanalytical (Apr 2014 - Jul 2014)

Supported sponsors' programs in GLP LBA and large molecule analysis, directed the bioanalytical CRO branch in Shanghai, China, and mentored staff. Directed transfer, development, validation and application of GLP methods. LC-MS for large molecules, ELISA-VIS, FL. Program and project management, resource allocation. Use of WEBEX to gain concurrence on documents, protocols, SOPs, reports. Designed evaluation protocol for selection of LC-MS-TOF for ADC.

Elusys Therapeutics, Pine brook, NJ

Director of Bioanalytical Chemistry and Outsourcing(Jun 2010 - Feb 2014)

Provided scientific, analytical, technical, and regulatory guidance for bioanalytical projects, identified and characterized non-contributory bands (Applied outsourced LCMS analysis with IEF). Supported quality reviews, directed method outsourced development (Vendor management), and sample analysis for multiple projects. Program and project management (MS Project). Statistical (Prism and Minitab) and graphic presentations to BARDA. LC-MS, IEF, ELISA UV, FL, CBA-UV. Use of Webex to review and approve protocols, Sops and reports.

ICON Labs/Biogen Idec, Cambridge, MA

Principal Investigator Manager, (Oct 2009 - May 2010)

Provided and mentored junior staff in scientific, analytical, technical, and regulatory guidance for GLP/GCP bioanalytical projects, implemented quality systems, and validated (IQOQPQ) analytical instrumentation LC-MS and ELISA-UV, FL, Software (Analyst and SoftMAx Pro) and automation. Wrote and published protocols, deviations, amendments, reports and SOPs.

Consultant, Aegisbioconsult (Dec 2008 - Oct 2009)

Supported bioanalytical and GLP regulatory projects, used in silico applications for identifying epitopes, metabolites, and fragmentation patterns.

Goodwin College, East Hartford, CT.

Adjunct Professor of Anatomy and Physiology, (Dec 2008 - Oct 2009) Resigned to take the position with ICON at Biogen.

Lab Director, Matrix Bioanalytical Laboratories, New Haven, CT (Jul 2007 - Dec 2008)

Evolved Matrix Bioanalytical from non GLP to GLP. Improved sample and reagent tracking, audited and improved internal processes, and provided PK/PD support in GLP studies. Improved SOPs, methods and validations to meet FDA and EMA guidance. LC-MS, UV, ELISA-UV. Reviewed and implemented computer systems validation (IQOQPQ). Wrote protocols, deviations amendments reports and SOPs.

Tandem Laboratories, West Trenton, NJ Technical Director, (May 2006 - Jul 2007)

Guided GLP method validation, developed GLP ligand-based assays, and supported sales efforts. Validated SpectraMax and SoftMax Pro, Watson, MSD and Excel sheets. Provided program and project management. ELISA-VIS FL, CI, MSD. Developed protocols, deviations amendments, CAPAs, reports and SOPs

MedImmune, Inc, Gaithersburg, MD

Research Manager II, Translational Biology, (May 2003 - May 2006)

Directed GLP bioanalytical method validation, managed bioanalytical outsourcing (vendor management), developed grid systems for sample processing, and selected LIMS vendors. Provided Program and project management, problem solving. TECAN, ELISA-VIS, FL, CBA, ADA. Validation of TECAN Freedom EVO-IQOQPQ. Developed protocols, amendments, deviations, CAPAs (Trackwise).

TherImmune Research, Gaithersburg, MD

Director of Method Development and Validation, (Jun 2002 - May 2003)

Directed GLP validation of bioanalytical methods, applied statistical and PK analysis programs, and prepared presentations for sponsors. Elispot validation, Coulter cell counter validation.

Application to evaluate efficacy of vaccines. Program and project management. Addition of

accessioning system to assign specific simple number to samples for processing. Problem solving. Conflict resolution. LC-MS, UV, FL, EC, LS, CI. ELISA-VIS, FL, ADA

Covance Labs, Chantilly, VA.

Director of Immunoassay Development and Validation, (Jul 2000 - May 2002)

Directed bioanalytical method development, validated biomarkers, and implemented cell-based assays for efficacy and neutralization. First validation of hybrid in situ assay for DNA aptamer.

ELISA-VIS, FL, CL. Provided program and project management.

Microtest Laboratories, Inc., Agawam, MA. Director of Chemistry, (Oct 1999 - Apr 2000)

Directed GMP validation of methods for medical devices, developed and applied methods for cleaning validation, and improved conductivity analysis. Validated method for GC identification of bacteria. ISO 9001 and 13485. Improved conductivity and TOC methods for cleaning analysis,

Oread, Inc., Farmington, CT.

Senior Scientist and Radiation and Chemical Safety Officer, (Feb 1997 - Oct 1999)

Supervised the development and validation of GLP analyses, characterized natriuretic components in urine, and served as radiation and carcinogen safety officer.

Hartford Hospital, Hartford, CT.

Supervisor of Toxicology, (1996-1997)

Supervised toxicology studies and analyses. GC-MS, ELISA, PEP, IEF, LC-UV, FL, PDA, EC

TSI Mason (Charles River), Worcester, MA.

Study Director, Bioanalytical Services, (1994 - 1996)

Directed bioanalytical services for small and large molecules. LC-UV, FL, EC.

Hartford Hospital, Hartford, CT. Clinical Chemist Trainee, (1992-1994)

Trained in clinical chemistry practices and protocols.

Membership:

AAPs AAPS-Ligand Binding Study Group Society for Quality Assurance Education:

PhD in Zoology (genetics and endocrinology) UMASS Amherst, MA,

BS in Biology and History, Texas A&M Commerce, Commerce, Texas.

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