Jacob Hartsell Email & Phone Number

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.
• Led the programmatic activities of a small team executing against bench and preclinical project plans.

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.
• 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.
• 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.

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..
• 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.
• 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.
• 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.

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.
• 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.
• 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.

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.
• Assisted team members in the design, fabrication, and verification of the device embodiments for different sensors in preparation for human clinical studies.

Master'S Degree, Chemistry

Bachelor'S Degree, Chemistry

Bachelor'S Degree, Biology, General