This position is reporting to the CTO. As part of the Combination Product Services team, the Associate Director for Combination Products will lead the technical and scientific strategy behind building, developing, and commercializing state-of-the-art combination product testing services. S/he will develop and execute a technology roadmap to enable the company vision as provided by the CTO and CEO. S/he will be responsible for managing the technology budget, making appropriate investments, and leading a first-in-class technical team that sources and implements new capabilities and provides technical support for customer acquisition and service delivery. This position serves as a key technical interface for us both internally and externally to support commercial development. S/he is responsible for sustainable knowledge management and transfer activities for the services platform and is expected to build strong working relationships with customers.

RESPONSIBILITIES

• Develops the technical and scientific strategy to deliver state-of-the-art combination product testing services to pharma and medical device customers

• Develops and executes a technology roadmap to enable the company vision and mission

• Manages the technology budget and capital investments

• Stays abreast of testing technology trends and changing regulations, standards, and environment relevant to combination products and impacting the component, medical device, and pharmaceutical industries

• Determines required scientific and technical organizational capabilities. Builds, develops, and manages a first-in-class technical team to source and implement new technologies and to provide technical support for customer acquisition and combination products service delivery. Acts as a mentor to team members.

• Responsible for technical initiatives to implement new programs, test methods, instrumentation, and procedures and leads competency development efforts across the organization related to combination product testing services

• Ensures all technology practices adhere to regulatory standards such as cGMPs.

• Responsible for sustainable knowledge management and transfer activities for the services platform

• Directs and contributes to development of technical content such as training modules, videos, or other materials as appropriate on our products, services, and/or processes for internal or external purposes. Serves as a technical expert and represents our capabilities in external forums such as major conferences and tradeshows or roundtable discussions

• Is a lead contributor to the sales process when developing or applying new technologies to projects. Serves a combination products expert, maintains a consumer-focused outlook, provides customer consultation and education, and aids in the delivery of customer projects

• Identifies, builds, and maintains an external network of experts/companies to support capabilities development and deployment

QUALIFICATIONS

• Knowledge of drug-device combination products and/or medical devices, including market available technologies from major industry suppliers

• Knowledge of the operation of mechanical measurement equipment (e.g. Instron) and container closure integrity instrumentation

• Knowledge of design control and system integration

• Knowledge of small-scale filling and component assembly (desirable)

• Experience with method validation and test protocol generation, execution, and reporting

• Application of statistical and analytical methods such as Design of Experiments, ANOVA analysis, and statistical software (Minitab, Jump, etc.) Working knowledge of industry standards and requirements (ex. cGMP)

• Ability to delegate effectively

• Superior communication skills, both written and oral

Education & Experience

• Master’s or PhD degree in a science or engineering discipline plus relevant experience related to combination product or medical device development and/or testing

• 15+ years working in a technological role within medical devices and/or pharma combination products with an increasing scope of responsibility

• 10 years managerial experience with increasing level of responsibility

• 5+ years working within a cGMP environment