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We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possibilities with us.

JOB DESCRIPTION 

As part of the Technology development team, the Combination Product Services Manager will manage technical and scientific activities related to combination product test method development and execution and will serve as the primary technical contact for pharmaceutical customers and our company laboratory operations. This position performs technical analyses of drug delivery systems, designs fixturing, develops test methods, and scouts and implements new testing technologies. They will plan, perform and analyze bench-level engineering tests or research experiments for drug-device combination products and medical devices.

RESPONSIBILITIES

Uses technical expertise to contribute to the customer sales process and service delivery, and maintains a customer-focused outlook:

• Understands, on a deep level, the technical needs and issues that customers are facing.

• Accurately collects, analyzes, challenges, and synthesizes customer requests/inputs and translates these into appropriate responses, solutions, services, and action plans

• Educates customers or internal associates on technical aspects of combination products and testing services as appropriate:

• Advises on service and/or product solutions for needs

• Answers technical questions and consults on approaches

• Aids and/or leads in the scoping of testing approaches, fixturing, protocols, and method validation and in the timely delivery of projects to customers.

• Closely coordinates with internal cross-functional team (business development, quality, service operations) to discuss and resolve challenges with service projects, and provide updates

• Develops training modules, videos, or other materials as appropriate on ZebraSci products, services, and/or processes

• Develops content for technical support, services and customer experience/journey as well as external presentations for select scientific conferences.

• Serves as a technical or scientific interface and represents ZebraSci capabilities in external forums such as major conferences

• Develops, maintains, and diffuses combination product services technology:

• Acts as an expert on combination products testing services, methodologies, and instrumentation. Supports technical initiatives and enables competency development efforts across the organization

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

• Stays abreast of testing technology trends and developments.

• Shares gathered intelligence and technical findings across the organizations network, and 3rd parties as appropriate

• Implements new programs, tests, methods, instrumentation, and procedures. Independently plans and performs experiments that support new product or technology feasibility testing.

• Develops new methodologies or conducts routine procedures as needed.

• Interfaces with machine shop to execute fixturing development and fabrication to support experimental designs and performs testing of product produced experimentally as required.

• Acts as liaison with machine makers, vendors, or other 3rd party entities:

• Identifies and establishes working relationships with external technology partners

• Maintains technical relationships with major equipment/machine makers, vendors, or other 3rd party entities

• Mentors and develops associates in related technical roles and provide frequent feedback

• Effectively communicates, orally and written, project progress both within the team and to senior leadership

• Performs other duties as required.

• Bachelor’s, 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:

• 1-3 years of experience with a PhD

• 3-5 years of experience with a MS

• 5-10 years with a BS

• 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), fluid dynamics and container closure integrity instrumentation

• Knowledge of small-scale filling and component assembly is desirable

• An understanding of design control and system integration is desirable

• Test protocol generation, execution, and reporting

• Application of statistical and analytical methods such as Design of Experiments, ANOVA analysis, Gage R&R and statistical software (Minitab, Jump, etc.)

• Superior communication skills, both written and oral.

• Manufacturing or Operational experience is a plus.

• Knowledge of 21CFR820.30, ISO 11040 series, 11608 series etc.