Quality Medical

Vincent E. Gaeta

Princeton, NJ ***** 609-***-****

*******@*****.*** www.linkedin.com/in/gaetavincent/

Senior Scientist

Laboratory Analysis Technical Writing Quality & Compliance

Innovative industry professional with diverse and robust experience in pharmaceutical industry and medical diagnostics fields. Strong background in project management and working in cGMP, GLP, and QSR lab environments. Apply extensive project, analytical, and data management skills and excellent interpersonal and writing skills to communicate effectively and find solutions.

Professional Experience

JOHNSON & JOHNSON

JANSSEN PHARMACEUTICAL, Raritan, NJ

Pre-Clinical Regulatory Writing, Discovery Sciences, Janssen R&D 2016, 2019-2020

Held accountability for planning, writing, reviewing, and finalizing regulatory documents for compounds in development and marketed products to ensure overall quality and timely delivery of nonclinical submission dossiers.

Authored Preclinical Development documents in support of global regulatory agency submissions, analyzing data and preparing text for summary documents (IBs, INDs, NDAs, BLAs, and CTDs).

Ensured all quality documentation was accurate with appropriate tables, graphs, and figures by representing Document Submissions Group on cross-functinal teams, including Primary Compound Development, Global Dossier, and Project Planning.

Led and coordinated teams, guaranteeing successful content of IB/IND/CTD/NDA/BLA submissions, including preparation and maintenance of accurate, detailed submissions content plans.

Product Risk Management, New Product Quality Engineering,

Janssen Product Quality Management 2017 - 2019

Analyzed marketed and in-development products for associated risks to calcuate risk benefit analysis.

Conducted product risk assessments, user FMEAs, and quality risk / benefit analyses with respect to patient/product interfaces.

JANSSEN PHARMACEUTICAL, Raritan, NJ

JANSSEN PHARMACEUTICAL Supply Chain Quality Control, Raritan, NJ

Senior Scientist, Department of Quality Control 1995 -2016

Conducted product release and stability testing under guidance of approved SOPs/STPs to certify quality, efficacy, and compliance of marketed products with respect to health authority guidelines.

Supported qualifications, validations, and test method transfers by authoring, revising, approving, and implementing vast array of protocols, SOPs, STPs, work instructions, stability documents, change controls, and associated reports.

Designed, conducted, and documented investigations of product nonconformance OOT, OOS, and CAPA events in accordance with FDA regulations. Drove timely resolution of nonconformance events, establishing robust documentation to support health authority scrutiny.

Developed, documented, designed, and implemented quality systems, ensuring GxP compliance.

Managed various projects, handling method and instrument validation, (IQ, OQ, PQ), method transfers, and equivalency studies and communicated findings to upper management.

Achieved 100% on-time release and stability testing by conducting QC, stability, and product release tests and reviewing and approving release testing data for accuracy, completeness, and procedural integrity.

Demonstrated QA knowlede by applying analytical methods, including Western Blot, electrophoresis (SDS and IEF), HPLC, Karl Fischer (KF), Gas Chromatography (GC), RIA, ELISA, threshold contaminant, and cell-based potency in-vitro bioassay methodologies.

Supported ongoing education through supervison and training of analysts in laboratory methodologies, mentoring analysts, and facilitating team behaviors across lab groups.

Coordinated and participated in internal laboratory and FDA audits, maintaining clear communication with FDA, internal regulatory, and QA groups during process.

Additional Relevant Experience

ORTHO DIAGNOSTIC SYSTEMS, INC., Raritan, NJ

Associate Scientist, Department of Bioanalytical Research & Development

CARTER WALLACE, WAMPOLE LABORATORIES, Cranbury, NJ

Associate Scientist, Department of Research & Development

NATIONAL HEALTH LABORATORIES, Plainview, NY

Laboratory Technologist, Department of Radioimmunoassay

CORNELL UNIVERSITY MEDICAL COLLEGE, New York, NY

Senior Research Technologist, Department of Pediatrics / Endocrinology

Education

Master of Science (MS), Biology / Neuroscience, New York University, New York, NY

Bachelor of Arts (BA), Biology, Hofstra University, Hempstead, NY

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