Founder and Principal Consultant / May, 2021 — December

JL Tox Consulting LLC is a provider of toxicology and medical device biocompatibility consulting services. We support all biocompatibility toxicology and chemistry projects, questions or concerns. Provide industry leading experience in new product development, MDR and CAPA remediation and lifecycle management including biocompatibility test plans, impact assessments, gap assessments, toxicological risk assessments and biocompatibility evaluations. Responsibilities: Act as a technical expert in toxicology and biocompatibility; Provide consulting to clients including risk assessments, biological evaluation test plans (including chemical characterization), biological evaluation test summaries and other expert opinion papers; Maintain up-to-date understanding of medical device industry standards and regulations including USP, AAMI, ANSI, ISO, BPOG, BPSA, ICH, PQRI, OECD Standards/Guidelines and global regulatory expectations. Achievements: Guided numerous sponsors to successful regulatory submissions related to Biocompatibility and successful product launches with no delays or issues from Biocompatibility.

Global Director Biocompatibility / September, 2023 — May, 2024

Abbott Laboratories is an American multinational medical devices and health care company with headquarters in Abbott Park, Illinois, United States. Abbott's core businesses focus on diagnostics, medical devices, branded generic medicines and nutritional products which have been supplemented through acquisitions. Responsibilities: Act as DRI of all global biocompatibility projects and regulatory submissions for Abbott Structural Heart, Abbott Neuromodulation and Abbott Cardiac Rhythm Management business units; Act as a technical expert in toxicology and biocompatibility for medical device products across all Abbott medical device franchises; Provide technical strategy and direction on risk assessments, biological evaluation test plans (including chemical characterization), biological evaluation test summaries and other expert opinion papers; Develop and deliver technical presentations for internal and external company seminars and training webinars etc.; Maintain up-to-date understanding of medical device industry standards and regulations including USP, AAMI, ANSI, ISO, BPOG, BPSA, ICH, PQRI, OECD Standards/Guidelines. Achievements: Built a track record of successful regulatory submissions with minimal to no deficiencies and zero additional testing needed to address regulatory questions; Maintained no disruption to Abbott business as a result of Biocompatibility issues; Successfully implemented cost savings efforts across Abbott franchises by means of reduced testing and reduced project delays due to Biocompatibility issues amounting to 4M+ annually.

Manager Biocompatibility / February, 2021 — September, 2023

Abbott Laboratories is an American multinational medical devices and health care company with headquarters in Abbott Park, Illinois, United States. Abbott's core businesses focus on diagnostics, medical devices, branded generic medicines and nutritional products which have been supplemented through acquisitions. Responsibilities: Manage operation of biocompatibility and toxicological risk assessment teams; Act as a technical expert in toxicology and biocompatibility for medical device products across medical device franchises; Provide technical guidance on risk assessments, biological evaluation test plans (including chemical characterization), biological evaluation test summaries and other expert opinion papers; Develop and deliver technical presentations for internal and external company seminars and training webinars etc.; Maintain up-to-date understanding of medical device industry standards and regulations including USP, AAMI, ANSI, ISO, BPOG, BPSA, ICH, PQRI, OECD Standards/Guidelines. Achievements: Successfully implemented internal toxicological risk assessment support; Oversaw toxicology and biocompatibility section in several successful regulatory submissions globally.

Contract Toxicologist Toxicology and Biocompatibility / January, 2019 — February, 2021

Johnson & Johnson is an American multinational medical devices pharmaceutical and consumer packaged goods manufacturing company founded in 1886. Its common stock is a component of the Dow Jones Industrial Average and the company is ranked No. 37 on the 2018 Fortune 500 list of the largest United States corporations by total revenue. Responsibilities: Acted as a technical expert in toxicology and biocompatibility for medical device products across medical device franchises; Provided risk assessments, biological evaluation test plans (including chemical characterization), biological evaluation test summaries and other expert opinion papers; Developed and deliver technical presentations for internal and external company seminars and training webinars etc.; Maintained up-to-date understanding of medical device industry standards and regulations including USP, AAMI, ANSI, ISO, BPOG, BPSA, ICH, PQRI, OECD Standards/Guidelines. Achievements: Provided toxicology and biocompatibility section in several successful regulatory submissions in the US and EU; Successfully implemented harmonization of toxicology and biocompatibility procedures across DPS medical device franchises; Successfully implemented remediation plan for new medical device regulations in the EU.

Senior Toxicologist Consulting Services / May, 2018 — December, 2018

WuXi Apptec is a leading global pharmaceutical and medical device open-access capability and technology platform with global operations. As an innovation-driven and customer-focused company, WuXi Apptec provides a broad and integrated portfolio of services throughout the drug R&D process. Responsibilities: Acted as a technical expert in toxicology and biocompatibility for medical device biologics and biopharma services; Provided consulting to clients including risk assessments, biological evaluation test plans (including chemical characterization), biological evaluation test summaries and other expert opinion papers; Developed and deliver technical presentations for internal and external company seminars and training webinars etc.; Maintained up-to-date understanding of medical device industry standards and regulations including USP, AAMI, ANSI, ISO, BPOG, BPSA, ICH, PQRI, OECD Standards/Guidelines. Achievements: Grew toxicology service offerings for WuXi Apptec's Advanced Therapies Unit; Successfully implemented a new marketing strategy for toxicology services that has led to securing multiple new projects and contracts.

Toxicologist Biocompatibility SME / February, 2017 — May, 2018

Eurofins is an analytical testing company which provides a full range testing services to the medical device and biopharmaceutical industries. Eurofins is made up of 16 laboratories across North America, Europe and Asia-Pacific with over 18000 employees worldwide. Responsibilities: Performed toxicological risk assessments of medical devices; Advised clients on chemical characterization and biocompatibility testing needs including cytotox, sensitization, irritation, acute/sub-chronic tox, hemocompatibility, genotox etc.; Developed and established new biocompatibility testing according to emerging standards; Maintained up-to-date understanding of medical device industry standards and regulations including AAMI, ANSI, ISO, ICH, PQRI, OECD Standards/Guidelines; Advised clients on 510(k) and PMA submissions including interacting directly with the FDA for pre submission meetings and Day-100 meetings; Wrote and published articles and presented at local and international conferences. Achievements: Established and grew Eurofins toxicology and biocompatibility presence in North America by establishing internal toxicological risk assessment procedures and policies, presenting and promoting company brand and services, working directly with clients and regulatory bodies to build and establish a presence within the industry in North America; Advised and guided multiple clients towards successful regulatory submissions by recommending the appropriate biological evaluation plan for their specific situation, advising them on the best path for their regulatory submission, completing toxicological risk assessments on their products and working directly with the FDA when questions arise; Lead the successful implementation of biocompatibility of breathing gas pathway testing services.