Lawrence Hetti

Quality and laboratory operations professional with 20+ years of experience in FDA-regulated medical device, combination product, biologics, and advanced therapy manufacturing and testing environments.

Background includes direct ownership of a biologic-device combination product at Medtronic (allograft tissue paired with syringe and surgical delivery instrumentation), spanning quality release, QC/QA oversight, packaging/labeling review, and FMEA risk assessment, plus hands-on Instron mechanical strength and package seal-integrity (fish tank) testing. Applies human factors principles to laboratory task and workflow design -- task-method redesign, ergonomic ELISA bench layout, and cognitive-load controls for viral sample handling -- plus a chemical safety innovation: a smart barcode on employee ID badges for instant point-of-use SDS access. Extensive experience managing the equipment lifecycle -- qualification, calibration, maintenance, and IQ/OQ/PQ validation -- across laboratory instrumentation (HPLC, UPLC, plate readers, osmometers, pH meters, cold-chain systems) in multi-program, multi-client operations.

Seven years of direct Medtronic experience under FDA 21 CFR Part 820, ISO 13485, and MDSAP, including service as front-room SME during FDA, ISO 13485, and MDSAP inspections and leadership of the site's first Cell Operating System conversion. Proven cross-functional partner with Engineering, Regulatory, and Quality with a consistent record of people leadership.

QC Analytical Manager - Minaris Advanced Therapies (formerly WuXi AppTec) - Philadelphia, PA

(2022-09 - 2026-03)

• Reviewed and approved IQ/OQ/PQ validation packages and managed equipment qualification -- across HPLC, UPLC, cytation plate readers, osmometers, pH meters, and refrigeration/cold-chain systems, including 21 CFR Part 11 assessments and data integrity reviews supporting concurrent multi-sponsor laboratory operations.
• Maintained sustained inspection readiness -- hosting multiple client and health-authority-aligned audits monthly; proactively resolved gaps and maintained calibration and training compliance.
• Coached and developed salaried scientists and supervisors -- built cross-trained bench strength and delivered measurable quality and throughput gains.
• Applied human factors principles to redesign laboratory task methods -- restructuring analyst workflows into discrete 5-10 second task steps to reduce cognitive burden and improve first-time-right execution.
• Designed ergonomic laboratory layout for ELISA assay workflows -- positioned plate readers adjacent to the biosafety cabinet (BSA) to eliminate analyst transport of positive sample trays across the lab, reducing contamination risk and physical strain.
• Designed a laboratory layout for safe handling of viral-positive and viral-negative samples -- incorporating cognitive-load and memory-mitigation controls to reduce sample mix-up risk and support analyst safety.
• Implemented a smart barcode on employee ID badges for instant point-of-use access to Safety Data Sheets (SDS) -- enabling analysts to immediately reference proper spill response and safe disposal procedures for lab chemicals during an incident.

Senior Quality Systems Supervisor - Medtronic - Eatontown, NJ

(2015-08 - 2022-09)

• Led the site's first Cell Operating System conversion for Final Packaging and Labeling -- redesigned physical equipment and workstation layout for the manufacturing cell, coordinating cross-functional qualification and change control documentation to complete the transition with no production or compliance disruption.
• Owned quality release and QC/QA oversight for a biologic-device combination product -- allograft tissue paired with syringe and surgical delivery instrumentation -- including packaging/labeling quality review and FMEA risk assessment, under FDA 21 CFR Part 820 and ISO 13485.
• Managed equipment lifecycle activities -- qualification, calibration, and maintenance scheduling -- for QC and product-release testing equipment supporting Class II/III device manufacturing operations.
• Served as front-room SME during FDA, ISO 13485, and MDSAP inspections -- led health-authority-aligned response generation and maintained proactive, sustained inspection readiness as an operational standard.
• Owned CAPA, deviation, and change control governance -- under a global QMS, driving root cause discipline and measurable reduction in recurring quality events.
• Led a Lean Six Sigma DMAIC initiative -- achieving a 30%+ reduction in cycle times and full elimination of product backorders, restoring supply continuity.
• Performed hands-on mechanical and package integrity testing -- conducted Instron tensile/compression strength testing on device and combination product components, and package seal integrity (dye penetration / bubble-leak, "fish tank") testing to verify design and packaging performance.

Reagent Manufacturing Supervisor - Immucor - Warren, NJ

(2014-05 - 2015-08)

• Led technology transfer from Stanford University R&D into commercial GMP manufacturing -- authored 56 GMP batch records under change control, qualified vendors, and delivered compliant launch on time.

Manager / Senior Supervisor, Quality Control - International Technidyne Corporation (ITC) - Edison, NJ

(2007-12 - 2014-05)

• Led FDA 483 remediation through structured gap assessment, root cause analysis, and CAPA governance -- rebuilt QMS documentation and compliance controls from the ground up; managed a 30+ person salaried and contract workforce.

Supervisor / Chemical Processing Supervisor - Biomet 3i - Palm Beach Gardens, FL

(2003-06 - 2007-02)

• Managed quality and operations for FDA-regulated dental implant manufacturing -- strengthened process controls, GMP compliance, and continuous improvement.
• Designed and implemented an automated acid-neutralization system for the acid-etching process -- removing the technician from manual neutralization of nitric acid, sulfuric acid, and hydrofluoric acid (HF) to pH 7 in a fume hood prior to drain disposal, eliminating a significant chemical exposure risk.

B.A. - Chemistry - Florida Atlantic University