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

Position: Associate Principal Scientist, Combination Product Design Verification (Associate Director Equi[...]
** Job Description
** Join our company’s Device Product & Process Development (DPPD) Team, which focuses on the design, development, and commercialization of novel biologic/drug/vaccine-device combination products for safe and effective delivery to their intended sites of action. The DPPD Team oversees the development of the device constituent within our pipeline of combination products, spanning various therapeutic areas and routes of administration, including inhalation, implantation, and injection.

The Associate Principal Scientist will lead the definition and execution of design verification strategies, and design transfers for testing readiness, which includes incoming and release tests for components and combination products. This position also supports other critical activities such as drug product and combination product final assembly processes validations. All activities will require collaboration with cross-functional teams both within and outside of Device Development & Technology.

The incumbent must be able to work well with employees at all levels to effectively engage and coordinate the implementation/ readiness and execution of design verification tests and methodologies in support of key development activities. Additionally, this position will require applying knowledge in drug and device product development, such as manufacturing process development and validation, design control, risk management, material and molding, design validation to create and execute design verification strategies that successfully supports the clinical instruction(s) and commercial market approval(s) of combination products.
** Principal Responsibilities
*** 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.
** Qualifications
* * Requirements:
* B.S. in Mechanical Engineering (or an equivalent field) + 8 years of combination product development experience; M.S. in Mechanical Engineering (or an equivalent field) + 5 years of combination product development experience; or a Ph.D. in Mechanical Engineering (or an equivalent field) + 3 years of combination product development experience.
* 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…