Lucius Fox Email and Phone Number
Jacksonville, NC, US
Lucius Fox's Location
Jacksonville, North Carolina, United States, United States
Lucius Fox's Contact Details
Lucius Fox work email
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Lucius Fox personal email
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Lucius Fox phone numbers
About Lucius Fox
SUMMARY OF QUALIFICATIONS• Results driven leader / manager with broad experience in the Medical Device Industry committed to understanding and meeting customer needs.• Broad experience across multiple industries, and practice areas including Human & Veterinary Dx, Cardiac, Diabetology, Bleeding Disorders, Clinical Chemistry, Immunoassay, Blood Coagulation Disorders.• Technical expertise in IVD assay technologies including, heterogeneous & homogeneous immunoassays, enzyme & substrate assays, coag assays and ion selective electrodes. Thin-Film and liquid assay formats. • Experience assessing new assay technologies for commercial application in novel IVD products.• Proven ability to work cooperatively across organizations (internal groups, suppliers, and strategic business partners) to resolve complex technical problems, project resources, and budgeting challenges.• Extensive experience using phase-gate design control processes and maintaining compliance with FDA QSR, GMP, GLP, and ISO regulations. Participated in FDA and ISO certification audits.• 6-Sigma/PEx (Black Belt) Trained & Certified.
Lucius Fox's Current Company Details
Lucius Fox Work Experience Details
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Adjunct InstructorCampbell University Adult & Online EducationJacksonville, Nc, Us
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Adjunct InstructorCampbell University Adult & Online Education Oct 2022 - Present -
Principal Consultant & Managing MemberPillar Medical Device Consulting, Llc Sep 2022 - PresentJacksonville, North Carolina
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Senior Director Process Development & Transfer / Product SupportIdexx Laboratories Jan 2021 - Sep 2022Westbrook, Maine, United StatesCreated and implemented a formal Manufacturing Process Development & Transfer organization focused on developing and scaling manufacturing processes for new IDEXX assay products across all lines of business. Developed organizational governance and operating model in collaboration with Assay R&D SLT peers and V&P of Assay R&D. Led / Managed leadership team of five senior direct reports to fully develop and implement operational models, develop key relationships with partner organization (Operations, QA, Program Management , IDEXX Lines of Business) and consistently deliver key new product development initiatives.
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Director, Clinical Chemistry R&DIdexx Laboratories Jul 2016 - Jan 2021Westbrook, MaineLed an organization of scientists and engineers to develop new in vitro diagnostic tests for us in veterinary medical applications in both network labs and in near patient testing. Products commercialized included IVD tests for Canine CRP, Progesterone, Bile Acids, Hookworm, Roundworm, Whipworm, and Giardia. Technology platforms employed included thin-film slide and a proprietary micro bead system for creating multiplexed panels on 96-well plate systems.Responsible for organizational development, employee performance management & career development, quality system compliance, safety, and technical oversight of all new product development activities. Interact with Program Management, Operations, Marketing and QA managers to ensure on-time delivery of new products. Work cooperatively to manage product development pipeline, engage companion key outside partnerships, develop organizational capability.
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Senior Director, Hemostasis Assay DevelopmentT2 Biosystems Jan 2015 - Jul 2016Lexington, MaDirect an organization of scientists and engineers in the development of novel IVDproducts to diagnose and direct treatment of critical hemostasis disorders includingcoagulopathy of trauma, deep vein thrombosis, DIC, and drug related monitoring.Responsible for organizational development, employee performance management & careerdevelopment, quality system compliance, safety, and technical oversight of all new productdevelopment activities. Interact with Program Management, Operations, Marketing andQRC managers to ensure on-time delivery of new products. Work cooperatively to manageproduct development pipeline, engage companion diagnostic partnerships, developorganizational capability, and identify new clinical biomarkers for future hemostasisproducts. -
Director, Metabolic Disease & Oncology RndOrtho Clinical Diagnostics Jan 2007 - Jan 2015Rochester, NyManagement Responsibilities• Direct an organization of 30 R&D scientists to develop new IVD assay products for use in clinical management of patients with metabolic diseases and cancer. Responsible for organizational development, employee performance management & career development, quality system compliance, safety, and technical oversight of all new product development activities. Interact with Program Management, Operations, and QRC managers to ensure on-time delivery of new products. Work cooperatively as part of the Assay R&D Management Team to manage product development pipeline, develop organizational capability, and identify new clinical biomarkers for future IVD products.Key Accomplishments• Commercialized the VITROS 5600 Integrated and VITROS 3600 Immunodiagnostic instrument systems. Assay R&D representative on program management team. Provided oversight for assay migration, claims, and validation studies.• Implemented literature review, training / education, seminar series programs to develop staff knowledge and expertise in Metabolic Disease and Oncology fields.• Executed clinical sample collection project to develop world-class metabolic disease research sample bank for conducting biomarker discovery & clinical verification studies. Provided oversight to project team in developing and implementing clinical protocol.• Currently developing new products for determination of biomarkers to diagnose prostate cancer, detect and treat HIV infections and manage patient nutritional status. -
Manager, Clinical Chemistry Assay Design CenterOrtho Clinical Diagnostics Apr 2003 - Jan 2007Management Responsibilities• Direct an organization of 50 R&D scientists (23 regular + contractors) to develop new IVD assay products for use on OCD’s automated Clinical Chemistry systems. Responsible for organizational development, employee performance management & career development, quality system compliance, safety, and technical oversight of all new product development activities. Interact with Program Management, Operations, and QRC managers to ensure on-time delivery of new products. Work cooperatively as part of the Assay R&D Management Team to manage product development pipeline, develop organizational capability, and identify new clinical biomarkers for future IVD products.Key Accomplishments• Commercialized 35 new IVD products for use with OCD’s 5,1 FS Clinical Chemistry System. New assays utilize an array of different reagent technologies including homogeneous IA, immunoturbidimetric, and enzyme technologies to assess key Serum Proteins, Cardiac Markers (CRP), Lipids (HDLC & LDLC), DOAs, and TDMs. Products were developed in parallel with 5,1 FS instrument platform to achieve coordinated instrument / assay launch.• Commercialized the VITROS 5,1 FS Clinical Chemistry System. Served as the Assay and Systems Engineering technical leader on the 5,1 FS Program Management Team. Directed the execution of technical worked need to achieve assay / system integration and acceptable analytical performance. Interfaced with customers and created market specific prototype applications as part of 5,1 FS “Market to Sell” program.• Commercialized the VITROS MicroSlide dHDL assay (reagents and calibators) for the determination of HDLC in human serum or plasma. This product is the only fully automated single-step method for HDLC on the market and affirms OCD’s leadership position in thin-film assay technology.
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Manager, Reagent Product SupportOrtho Clinical Diagnostics Oct 2000 - Apr 2003Management Responsibilities• Report to Director of Product Support, Director of Quality Assurance, and Vice-President of Rochester Operations on projects that generated an ROI of $1 MM per year through improved product design and manufacturing productivity improvements. Interface with internal customers, suppliers, and strategic partners at two manufacturing sites to understand business objectives, establish project priorities, and track progress against goals. Oversee and prioritize approximately 35-50 projects and investigations of varying scope, a $2.0 MM annual budget, and multiple teams of 4-5 scientists, engineers and technicians. Responsible for employee performance management (10 scientists/engineers and 4 technicians), quality system training, and PEx training / certification.• Provide oversight for the investigation and resolution of raw material and manufacturing process problems to ensure quality and maintain supply continuity. Work cooperatively with managers and engineering staff in QA / QE, Operations, and Manufacturing Engineering.Key Accomplishments• Implemented a process for managing potential supply discontinuity issues related to product and manufacturing process problems.• All nonconforming products were contained within B-313 / B-642 manufacturing sites or OCD distribution centers and were properly dispositioned.• LIFR of >98% was maintained. No individual product stock outs.• Successfully transferred processes for extruding and slitting process for CVR polystyrene web materials used to manufacture MicroSlide ISEs (Na, K, Cl, CO2) to a new supplier. Project generated $1.2 million in productivity improvements and secured CVR supply chain.• Successfully completed the transfer of 6 key MicroSlide products to a 32-slit format to achieve an annual productivity improvement of $500,000.
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Principal ScientistOrtho Clinical Diagnostics Jan 1997 - Oct 2000• Principle contributor to a 10-year technical strategy for OCD’s Clinical Chemistry business. Specified 4 new clinical chemistry analyzer concepts that employed the integration of OCD’s thin-film assays and liquid reagent assays to rapidly address menu expansion needs. Participated in the development early system concepts for the 5,1 FS instrument program and associated supplier technology assessments. • Led a team of 5 Ph.D. scientists/engineers to assess commercial viability of cutting edge FT Near Infrared spectroscopy & chemometric technologies for use in clinical chemistry applications. Directly responsible for project goals and business case, team structure, technical strategy, budget, and timelines. Developed strategic alliance with an outside company, co-lead contract negotiations, and managed the external relationship.• Directed a team of 3 engineers and 3 technicians that improved thin-film Ion Selective Electrode (ISE) assays. Developed assay prototyping equipment and process. Demonstrated miniaturized ISE assays based on silver-ink electrode coatings that reduced UMC by 30% and increased analyzer throughput. Directly responsible for project goals, team structure, technical strategy & timeline and $500 K budget.• Directed team of 4 Ph.D. scientists and 2 technicians that developed an improved formula and process for manufacturing sandwich immunoassay for C-Reactive Protein. Identified improvements that will reduce annual production costs by $300 K. Directly responsible for project goals, team structure, technical strategy and timelines and $1 million budget.
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Senior ScientistOrtho Clinical Diagnostics Nov 1994 - Jan 1997• Developed an optical model for thin-film immunoassays. Utilized HPLC and spectroscopic methods to characterize assay registration system. Used model to decode problems encountered by product development teams and to reduce development cycle-time.• Developed HIC chromatography methods to characterize and purify HRP labels for use in competitive immunoassay.
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Research ScientistEastman Kodak Company 1989 - 1994Imaging Systems Engineering Laboratory• Created imaging efficiency models. Analyzed bromoiodide emulsions to create new high-speed emulsion technology. Co-invented proprietary tabular-grain emulsions that are found in Kodak Max 800 speed color negative film.• Discovered surface selective sensitizing agents to boost the sensitivity of photographic emulsions. Materials are employed in latest generation of Kodak Gold 200-speed film.
Lucius Fox Skills
Fda
Design Control
Immunoassays
Gmp
Glp
Medical Devices
R&d
Protein Chemistry
Assay Development
Laboratory
Biomarkers
Commercialization
Product Development
V&v
Quality System
Hplc
Oncology
Chemistry
Chromatography
Biochemistry
Hardware Diagnostics
Biotechnology
Quality Assurance
Spectroscopy
Process Improvement
Cancer
Validation
Technology Transfer
Lifesciences
Research And Development
Life Sciences
Good Laboratory Practice
High Performance Liquid Chromatography
Ivd
U.s. Food And Drug Administration
Lucius Fox Education Details
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Chemistry
Frequently Asked Questions about Lucius Fox
What company does Lucius Fox work for?
Lucius Fox works for Campbell University Adult & Online Education
What is Lucius Fox's role at the current company?
Lucius Fox's current role is Adjunct Instructor.
What is Lucius Fox's email address?
Lucius Fox's email address is lu****@****exx.com
What is Lucius Fox's direct phone number?
Lucius Fox's direct phone number is +178145*****
What schools did Lucius Fox attend?
Lucius Fox attended Caltech, The Ohio State University.
What are some of Lucius Fox's interests?
Lucius Fox has interest in Photography.
What skills is Lucius Fox known for?
Lucius Fox has skills like Fda, Design Control, Immunoassays, Gmp, Glp, Medical Devices, R&d, Protein Chemistry, Assay Development, Laboratory, Biomarkers, Commercialization.
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