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Ken Root is listed as Manager, External Supply Integration Quality at The Janssen Pharmaceutical Companies of Johnson & Johnson, based in Lansdale, Pennsylvania, United States. AeroLeads shows a work email signal at janssen.com and a matched LinkedIn profile for Ken Root.
Ken Root previously worked as QA Associate at Lab Support and Manager, QA and RA at Biocoat, Inc.. Ken Root holds Bs, Biochemistry from Lehigh University.
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Experienced Quality Assurance manager in the Pharmaceutical, Medical Device, and Biologics industries with extensive experience in the quality oversight of external manufacturing sites and partners in the development of new products. Products include sterile and non-sterile pharmaceutical drug products, API, and intermediates, medical devices, and drug/device combination products from early clinical phase through commercial transfer and pre-approval inspections. Managed quality departments, qualification and auditing projects and process improvement teams at both large companies and startups, in order to ensure quality and compliance.Recent hands-on experience in the clinical development of sterile fill finish DP, oral solid dose DP, vaccines, radiological products (biomarkers), cell therapy products, polypeptides, component materials and intermediates. Recent experience in new modalities such as direct-to-patient initiatives, formulate-on-demand compounded products under USP 797. Duties included performing quality auditing to ensure on-time site qualifications, day-to-day quality review of batch records, investigations, and CAPA, and management of the partner relationship. Current involvement with process streamlining committees and technology roadmapping teams for the implementation of digital solutions and automation. Recent introduction to A.I. and machine learning.
Listed skills include Fda, Gmp, Capa, Regulatory Affairs, and 31 others.
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Raritan, New Jersey, US
Drove Quality leadership & oversight for the development of early and late phase pharmaceutical products including large and small molecule drug product, API & intermediates, pharma/device combination products, vaccines, polypeptides, radiologicals, cell therapy, compounding pharmacies, and new modalities such as formulate-on-demand and direct-to-patient.
Member of the Quality Management group in a fast paced, technology-driven pharmaceutical company employing a flat organization and the latest in software and equipment, including continuous manufacturing lines and fully electronic batch records. Hands-on involvement with manufacturing operations and analytical laboratory for the contract manufacture of.
Horsham, Pennsylvania, US
Manager of the Quality Assurance and Regulatory Affairs dept. Responsible for oversight of the QA dept, hosting external auditors, management review, and communication with the FDA, Notified Bodies, and Authorized Representatives for a class II medical device and biologically derived component materials. Maintained close contact with manufacturing.
Supported all Quality Operations functional areas including quality systems, management of partners, and oversight of the San Diego academic lab commercialization project. Assisted in development of draft Quality Manual. Supported the sterile pharmaceutical and medical device programs. Also supported clinical database validation, and performed audit of.
Served as project liaison / project manager for Discovery Labs' commercialization and compliance project at University of California at San Diego (UCSD) Medical Center. Set up the pharmaceutical QA program. Interfaced with physicians, lab personnel, & university departments. Used local resources (hospital and external) for calibration, information.
Rahway, New Jersey, US
Computer validation of lab software, LIMS templates, and some lab instrumentation. Administered lab server and database. Explored and implemented new software for the lab. Maintain relationships with software vendors. Aligned department practices with business principles, company objectives, and GMPs.
Rahway, New Jersey, US
Maintained $1M inventory of lab chemicals, testing equipment, and glassware. Oversaw the lab's reference standards program. Operated within an approximate $1M annual stockroom budget. Optimized inventory reorder points and lead times for a 100-person lab. Developed partnerships and supply/pricing agreements with key vendors. Oversaw lab chemical.
Rahway, New Jersey, US
Reviewed CMC data (lab & manufacturing) for inclusion in regulatory submissions such as NDA, Annual Reports, and Supplements. Performed GMP inspections of manufacturing and lab departments and provided QA floor presence. Co-hosted audits by joint venture companies. Coordinated a commitment response to the MCA (now called MHRA). Worked on loan and trained.
Rahway, New Jersey, US
Wrote Annual Product Reviews of manufacturing and lab processes. Performed statistical analyses to assess process data. Products included OSD tablets, capsules, sterile parenterals, intermediates, and veterinary products. Worked closely with the product release group.
US
Reviewed and processed data from clinical trial Case Report Forms (CRFs) for ReoPro and Remicade.
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Ken Root works for The Janssen Pharmaceutical Companies of Johnson & Johnson.
Ken Root is listed as Manager, External Supply Integration Quality at The Janssen Pharmaceutical Companies of Johnson & Johnson.
AeroLeads has found 2 work email signals at @janssen.com for Ken Root at The Janssen Pharmaceutical Companies of Johnson & Johnson.
Ken Root is based in Lansdale, Pennsylvania, United States while working with The Janssen Pharmaceutical Companies of Johnson & Johnson.
Ken Root has worked for The Janssen Pharmaceutical Companies Of Johnson & Johnson, Lab Support, Biocoat, Inc., Discovery Laboratories, Inc., and Independent Consultant.
You can use AeroLeads to view verified contact signals for Ken Root at The Janssen Pharmaceutical Companies of Johnson & Johnson, including work email, phone, and LinkedIn data when available.
Ken Root holds Bs, Biochemistry from Lehigh University.
Ken Root is listed with skills including Fda, Gmp, Capa, Regulatory Affairs, Validation, Medical Devices, Sop, and Pharmaceutical Industry.
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