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Jacob Hartsell is listed as Senior Manager, Innovation at BD, based in Raleigh-Durham-Chapel Hill Area, United States. AeroLeads shows a work email signal at bd.com and a matched LinkedIn profile for Jacob Hartsell.
Jacob Hartsell previously worked as Senior Manager at Bd and Senior Project Manager at Bd. Jacob Hartsell holds Master'S Degree, Chemistry from East Carolina University.
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Scientist and manager with 17+ years of R&D, Product Development, Personnel and Project Management experience in the medical device industry. Device development proficiency with an extensive background in combination products and early stage of clinical evaluations. Current efforts at BD Technologies & Innovation in the Medical Innovation team focus on innovating medical technologies with emphasis on translational research from concept to launch, including iterative design evaluation, preclinical and clinical development, evidence generation, and de-risking clinical outcomes and product timelines.
Listed skills include Clinical Research, Project Management, Medical Devices, Polymer Chemistry, and 3 others.
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Franklin Lakes, New Jersey, Us
-> Current efforts focus on innovating medical technologies with emphasis on advancing projects through the BD Medical Innovation pipeline and reducing technical risks.• Responsible for delivering on Innovation’s project portfolio• Establish and manage multiple concurrent project plans including tasks, milestones, and dependencies • Lead programmatic activities of a team executing against bench and preclinical project plans
Franklin Lakes, New Jersey, Us
-> Developed and executed partnership strategies providing essential support for both clinical and non-clinical operations, which addressed critical challenges facing external pharmaceutical customers.• Offered early-stage manufacturing, preclinical, and clinical insights to guide feasibility and development agreements. • Collaborated with key BU stakeholders to develop and implement testing strategies to reduce in-clinic performance risks for drug-device combination products.• Provided feedback and recommendations for clinical (and early-stage commercial) roadmaps to external customers for drug development and combination device products.• SME for prefilled systems as well as the GMP fill-finish processes supporting multiple medical device platforms.-> Identified strategically aligned CDMO organizations and cultivated strong, long-term business relationships to support multiple BD product platforms.-> Established and managed multiple concurrent project plans including tasks, milestones, and dependencies through an iterative product development life cycle.• Led the programmatic activities of a small team executing against bench and preclinical project plans. • Developed and implemented Evidence Generation Plans addressing key market/industry concerns for multiple ADDS device platforms.• Prepared and submitted regulatory packages (FDA and ANSM) for early-phase human feasibility studies for drug/device combination prototypes. -> Provided key infrastructure support for the COE: budget management and reconciliation processes, talent recruitment, associate professional development activities, and generation of quotes as well as value propositions designed to support external customer interactions.
Franklin Lakes, New Jersey, Us
-> Developed Interconnected Diabetes Management (IDM) systems designed to collect data from multiple sources, aggregate and analyze those data, and provide actionable intelligence for better health outcomes.• Led team in the execution of three human clinical studies. Interviewed CROs and conducted site visits to select the best fit based on study parameters. Prepared clinical protocols as well as EU and Health Canada regulatory submissions.• Performed ethnographic research to confirm key unmet needs and user-testing to validate key design parameters.• Coordinated the successful development and V&V testing of two IDM systems using agile concepts and tracking systems (JIRA) with geographically dispersed teams. Used Scrum to expedite the development and led sprint planning sessions, daily standups, backlog management, and bi-weekly sprint reviews.• Collaborated with data scientists and behaviorists to embed algorithms and implement contextual content in the mobile application and the messaging/notification system of the IDM solutions. • Partnered with the lead engineers to successful integrate and test hardware, software, and notification systems. -> Prepared submission materials including technology map, competitive analysis, data summaries, product timeline, and cost estimates for external funding/grant applications.-> Led manufacturing and filling efforts for various prototype devices used in human clinical studies. Interviewed CMOs and conducted site visits to determine the best fit based on project needs.
Franklin Lakes, New Jersey, Us
• Coached and mentored a team of 6 project associates while leading the chemistry and device development efforts of a CGM biosensor. • Established aseptic sensor manufacturing protocols in an ISO class 5 cleanroom under GMP. Responsible for the execution of V&V, the in-vitro, and in-vivo performance testing for devices used in human clinic studies. Coordinated the device manufacturing and sterilization efforts necessary to execute multi-day ambulatory human clinical studies. • Collaborated with diabetes clinics to develop protocols and regulatory documents necessary for human clinical studies. Performed training for clinical staff and provided on-site technical support for all devices and systems used the duration of the studies. • Led the internal and external efforts to evaluate root cause analysis for sensor failure and well as efforts to implement remediation strategies. Incorporated various platinum-based oxidation remediation strategies and outer-layer coating chemistries into the sensor embodiment. Developed novel characterization techniques and assays to verify device functionality and reduction of peroxides. • Designed and executed a test plans for residual reagents, interferent substances, protein quantification, leaching studies, as well as developed formulations to allow for terminal sterilization of the final device embodiment.
Franklin Lakes, New Jersey, Us
• Prototyped sensor embodiments that functionalized a fluorescently labeled glucose binding protein for both in-vitro and in-vivo testing. • Established GMP pilot operations for the fabrication and assembly of sensors in a Class 100 modular manufacturing/assembly are in advance of clinical testing. Designed and executed test protocols for the sterilization validation, sensor stability, and process capability as well as set up sterilization processes and conducted full toxicology testing for the protein used in the biosensor.• Collaborated with diabetes clinics to develop protocols and work instructions for human clinical studies. Performed device training for clinical study staff and provided on-site technical support for all devices and systems used the duration of the studies. • Evaluated the competitive landscape on of similar technologies and assessed their performance against developed devices in a pre-clinical setting. • Led collaborations with external partners investigating the use differential mobility spectroscopy (DMS) to analyze tuberculosis (TB) samples. Developed and implemented BSL-3 protocols for handling TB-positive clinical samples. Procured and tested of clinical specimens using DMS-MS for analysis of metabolites and biomarkers related to pulmonary tuberculosis.
Franklin Lakes, New Jersey, Us
• Designed methods to fabricate and apply sensing hydrogel to a fast response, small volume biosensor that accurately tracked capillary blood glucose in-vivo reproducibly with little to no lag. • Developed and tested various polymeric (PEG, HEMA) matrices with embedded fluorescently labeled proteins that displayed acceptable bench-top stability, 34°C stability and demonstrated the ability to track core blood glucose in-vivo. Developed outer-layer coating formulations that demonstrated the ability to increase sensor longevity, while maintain sensor performance in-vivo.• Assisted team members in the design, fabrication, and verification of the device embodiments for different sensors in preparation for human clinical studies.
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Jacob Hartsell works for BD.
Jacob Hartsell is listed as Senior Manager, Innovation at BD.
AeroLeads has found 2 work email signals at @bd.com for Jacob Hartsell at BD.
Jacob Hartsell is based in Raleigh-Durham-Chapel Hill Area, United States while working with BD.
Jacob Hartsell has worked for Bd.
You can use AeroLeads to view verified contact signals for Jacob Hartsell at BD, including work email, phone, and LinkedIn data when available.
Jacob Hartsell holds Master'S Degree, Chemistry from East Carolina University.
Jacob Hartsell is listed with skills including Clinical Research, Project Management, Medical Devices, Polymer Chemistry, Protein Chemistry, Assay Development, and Aseptic Processing.
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