Senior Principal Scientist - Device Technical and Engineering Lead; Senior Director Equivalent

Position: Senior Principal Scientist - Device Technical and Engineering Lead (Senior Director Equivalent)
Location: West Point

** Job Description*
* ** Senior Principal Scientist - Device Technical and Engineering Lead (Sr. Director Equivalent)*
* _Our company's Device_   _Product & Process_   _Development (D_  _PP_  _D) Team designs, develops, and commercializes novel biologic/drug/vaccine - device enabled combination products to achieve safe and effective delivery to their intended site of action.  The D_  _PP_  _D Team manages the development of the device constituent of our company's pipeline of combination products across a variety of therapy areas and routes of administration including inhalation, implantation, and injection.  _

** Job description*
* This position will be responsible for applying their knowledge of product and process development in the (bio) pharmaceutical and/or medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.
This position interacts extensively with subject-matter experts on the DPPD team and members of internal cross-functional product development teams from concept through product launch.  Additionally, the position will ensure products and processes are developed in accordance with applicable regulatory, quality, company, and customer requirements.

This position will lead cross-functional development teams within and external to Device Development & Technology. The incumbent must be able to work well with all levels of employees and be able to effectively coordinate the execution of device development strategies. This individual will be expected to apply their knowledge of product design and development; manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical and commercial combination product development and launches.

** Principal Responsibilities*
* + Lead and set direction for the device development strategy formultipledrug-device combination product development programs ranging from concept generation/selection, development,verification, and validation tolaunch readiness:​

+ Lead the cross-functional Device Working Groupsto ensure full integration of the device development activities with the clinical, regulatory, formulation, commercial and other key functions.

+ Lead the Device Development Engineering Core teamsfocused on development of design requirements for the combination product and engineering execution against the established requirements.

+ Represent Device Development and the project-specific Device Working Groupson cross-functional teams, including the Development and Commercialization Team (DCT). Additionally, maintain engagement with Early Development Teams (EDT) and Product Development Teams (PDT).

+ Serve as key point-of-contact with potential external device designers, developers, and suppliers for selecteddevice technology platforms.

+ Oversee and serve as a technical integrator ofall device development activitiesincludingengineering design, engineering analysis and testing, medical device design controls, risk management, test method/fixture development, design verification and validation, injection molding, automated assembly, and human factors analysis.

+ Proactivelyanticipate and resolve project obstacles andeffectivelycommunicatecomplex product technical challenges,device development strategy,timelines, milestones, and riskswithinour Company and with external suppliers

+ Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership.

+ Lead/support/oversee clinical supplies production with respect to device component manufacture and final assembly of biologic/drug product with device constituent part.

+ Lead/support the development, implementation and continuous improvement of Device Development and Device Project Leader processes,procedures,and tools.

+ Maintain a high level of engagement in the program-specific design controls process and design history file development.

+ Stay current with new device technologies, relevant worldwide regulations, standards, and effectively share…