Associate Principal Scientist, Combination Product Design Verification; Associate Director Equi

Position: Associate Principal Scientist, Combination Product Design Verification (Associate Director Equi[...]
* Lead, set direction, align with key stakeholders, and successfully execute, design verification strategies for assigned drug-device combination product program(s) for successful clinical introduction(s) and commercial market(s) approval(s).  + Define design input(s)/ output(s) and lead associated combination product design verification plan, protocol(s), and report(s) that demonstrate design output(s) meet design input(s).  + Lead establishment of test methodologies, including method development and validation, internally or externally, per design verification strategy.  

+ Lead strategy and execution of accelerated and real time aging studies including bridging studies at the device component/ subassembly/ in-process material and combination product level.  + Lead stablishing test methodologies/ testing readiness and execution in support of critical activities such as stability studies, drug product filling process validation, combination product final assembly process validation, shipping studies, etc.  + Support establishment of incoming and release tests at the component and combination product level with key functional areas.  

+ Oversee design verification activities performed by external partners.
* Proactively anticipate and resolve project obstacles and effectively communicate complex product technical challenges, design verification strategy, timelines, milestones, and risks within our Company and with external partners.
* Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership.
* Lead/ Support clinical supplies production with respect to device component and combination product testing.
* Maintain a high level of engagement with cross-functional team members to effectively implement and successfully execute against design verification strategies.
* Stay current with new device technologies, relevant worldwide regulations, standards, and effectively share this knowledge with others.
* Enhance our Company’s professional image and competitive advantage through publications, presentations, patents, and professional activities.
* Leadership experience of combination product design verification programs and leading activities (e.g., strategy/ plan, protocol(s), report(s), test method development/validation, etc.) requiring cross-disciplinary project teams.
* Leadership experience with comprehensive knowledge of various aspects of device development and their interdependencies with design verification, including but not limited to, design controls, risk management, materials & molding, process development and validation, secondary packaging development & qualification, and design validation.
* Comprehensive understanding of drug product development in addition to device development expertise.
* Strong familiarity with regulatory landscape associated with drug delivery combination product and design verification requirements.
* Strong working knowledge of standards relevant to device components and combination products, including ISO 11608, ISO 11040, ISO 80369, as well as performance tests related to container closure integrity and dose accuracy, among others.
* Proven track record of applying analytical skills in product test method design, development, and validation.
* Working knowledge of analytical test method technology transfer process.
* Skilled in laboratory good documentation practices and electronic documentation systems.
* Self-motivated with ability to work independently.
* Proven ability to lead teams of many skill sets and backgrounds.
* Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership.
* Excellent communication, prioritization, presentation, negotiation, project management, and organizational skills.
* Willing to travel
* Combination product drug delivery device components – plastic, metal, glass, elastomeric materials, etc. – fracture, stress-strain response, friction, hardness, surface roughness, surface energy quantification.
* Combination product sub-assemblies (including…