James Oberhauser, Ph.D. Email & Phone Number

Delivers value by driving strategy creation and tactical execution in the development and commercialization of medical devices, drug delivery devices, and other combination products. OC LLC also offers executive leadership support leveraging experience building and leading a device, package, and sterile process development function at a Fortune 500 pharmaceutical company.

Foster City, Ca, Us

RESPONSIBILITIESApply a product system and lifecycle planning mindset to set the strategy and execute tactics to drive development of sterile processes, drug delivery devices, and primary, secondary, and tertiary packaging solutions in support of the Gilead product development enterprise. Establish and maintain a network of external partners to explore innovative technology and accelerate product development. Collaborate with adjacent stakeholder functions to fulfill technical, business, and quality objectives.ACHIEVEMENTS• Transformed a 6-person clinical packaging team into a 35+ person organization chartered with development of drug delivery device product systems, sterile processes and parenteral container closure systems, and primary, secondary, and tertiary packages• Established and refined a medical device / combination product design control and risk management quality system compliant with global health authority regulations (e.g., 21 CFR Part 820/Part 4, EU MDR, ISO 13485/14971)• Collaborated with a device partner to develop a bespoke gas-powered autoinjector capable of delivering a high viscosity (ca. 220 cP) formulation through a 25G needle, including proof-of-concept of a digitally connected device that led to four patent filings• Oversaw a strategic network of device and packaging component suppliers, contract manufacturing organizations for packaging and device assembly, and consultant services• Developed stage-gate governance to support technical, business, and quality oversight of programs and promote efficient decision-making• Implemented practices to establish and maintain qualification of all controlled temperature shipping containers across the Gilead internal manufacturing and distribution enterprise• Forged strong collaborative relationships with Quality Assurance, Regulatory CMC, Manufacturing Operations, Global Supply Chain, Commercial Strategy, and Product Strategy Teams to meet business goals efficiently and effectively

Foster City, Ca, Us

• Deliver strategic insights into drug delivery and medical device product development, supply chain and manufacturing process development and scale-up, global regulatory submissions, and product characterization

Eindhoven, North Brabant, Nl

• Deliver strategic and tactical insights related to structural heart product development• Identify technical and regulatory risks and articulate the paths forward to mitigate them• Craft the product narrative describing the coupling between biology and product performance that delivers clinical success

Abbott Park, Illinois, Us

RESPONSIBILITIESDevelop technology and upstream manufacturing operations for first-in-class fully biodegradable polymer stent to treat stable and unstable angina, acute myocardial infarction (MI), and multiple-vessel disease. Perform extensive product characterization studies and author global regulatory filings and responses to questions. Solicit voice of customer feedback to guide product development.ACHIEVEMENTS• Commercialized the world’s first biodegradable drug-eluting coronary stent, bringing it from first-in-human clinical experience to manufacturing process scale-up, global regulatory approval, and launch• Developed clinical and commercial scale unit operations for extrusion, blow molding, and laser cutting of a polymeric stent• Managed 20-person team with $10M annual budget with responsibility for materials selection and characterization, manufacturing process development, and global regulatory submissions• Delivered global presentations to interventional cardiologists to drive product positioning and pipeline strategy• Led innovation team chartered with product life cycle management improvements in the biodegradable stent category• Engaged in offensive and defensive patent exercises to protect current and future business interests

Charlottesville, Va, Us

RESPONSIBILITIESBuild and sustain a graduate research program studying industrially relevant problems in rheology, polymer processing, and structure-property relationships in complex fluids. Educate undergraduate and graduate students in chemical engineering principles. Support the School of Engineering and Applied Science service mission.ACHIEVEMENTS• Generated over $1M in individual research funding through successful grant proposals• Led a successful $1.1M collaborative research grant spanning three universities• Built a polymer science research laboratory and managed a graduate student research program that produced two Ph.D. and one M.S. graduate

Pasadena, Ca, Us

RESPONSIBILITIESPerform novel research aimed at generating high-quality peer-reviewed journal publicationsACHIEVEMENTS• Designed novel experiments on the effect of polymer chain architecture upon crystallization kinetics and microstructure• Led scientific team performing synchrotron X-ray scattering experiments• Authored 4 articles in high impact, peer-reviewed scientific journalsAdvisor: Prof. Julia A. Kornfield

Ph.D., Chemical Engineering

M.S., Chemical Engineering

B.S., Chemical Engineering

Education record