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Senior Director (Head), Primary Container and Device Development

Leads an internationally disperse group of people managers and advanced scientists and engineers responsible for designing and developing devices and primary packaging solutions for chemical and biologic NMEs. Scope of work includes establishing and driving the implementation of combination product technology including device and packaging technology platforms. In addition, support existing commercial products and processes at internal and external manufacturing sites.   The Senior Director will provide scientific leadership and manage group budget and resource allocation for the Primary Container & Device Development group consistent with CMC team and JSC objectives and timelines. The position is responsible for driving innovative primary container and device development strategy within PCD through collaboration with the Therapeutic Area R&D and Commercial Leads, including design and implementation of combination product technology, and management of the combination product development process. The Senior Director will also drive development of the Customer Centered Design strategy in DPDS.   Identifies technology solutions and drives the development of combination product technologies to achieve improved therapeutic outcomes, product differentiation and customer centered design.   The Senior Director will lead the design and implementation of a diverse scope of device designs including needle safety, manual injectors, auto-injectors, nasal sprays, dry powder inhalers, catheters, patch pumps, targeted delivery platforms, etc; Drives strategic programs evaluating different delivery and device technologies for emerging product concepts across diverse therapeutic areas/functions. Serves as the key technical point of contact for all packaging, delivery device issues in development or in commercial operations and applies resources as needed to supporttroubleshooting problems in development and commercial processes.   Will develop and implement talent strategies, implement hiring, provide people-related decisions that cultivates innovative culture.  Leads discussions to identify new scientific/technical opportunities, external partnerships for discovery and outsourcing of non-core activities.    Will significantly improve, change or develop new business/work processes to share knowledge, build intellectual capital, build strategic technical capabilities and promote innovation throughout the organization.   They will negotiate and solicit acceptance of new ideas, approaches, concepts through scientific leadership and acts as a senior internal expert with a direct impact on JRD/JSC scientific and/or business objectives. Influences across disciplines with senior leaders and external colleagues/ partners to drive and align strategic and operational scientific activities across regions, therapeutic/functional areas; Provide scientific leadership and manage group budget and resource allocation for the Primary Container & Device Development group Drive the development of combination product technologies to achieve improved therapeutic outcomes, product differentiation and customer centered design Develop and implement talent strategies, implement hiring, provide people-related decisions that cultivates innovative culture Improve, change or develop new business/work processes to share knowledge, build intellectual capital, build strategic technical capabilities and promote innovation throughout the organization Build relationships with key adjacent functions such as Device Quality, Device Regulatory, JSC Tech Ops, Commercial, and Strategic Sourcing. Build reputation and visibility for PC&D internally and externally Represent PC&D on Small and Large CMC Councils Qualifications A minimum of an Master's degree is required A PhD is preferred Education in Engineering or another Science Related Discipline A minimum of 15 years of experience is required Expertise in Pharmaceutical Dosage Forms, Drug Delivery and/or Device and the overall drug development process developed through experience is required A positive track record in multiple R&D or Commercial disciplines is required, including experience in chemical and/or biological pharmaceutical processes and products A track record with increasing ability to develop/negotiate organizational support for technology-enabled products and concepts through scientific leadership and strategic influence across disciplines/departments at all levels of the organization, experience with external partners to drive and align scientific and operational activities is required Demonstrated people management and leadership experience with a proven track record of directly leading complex scientific team(s) and core technical leaders and managers of managers across functions/regions for an extended period of time.   Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the team is required Strong analytical problem solving skills and organizational skills is required 00001E47
Salary Range: NA
Minimum Qualification
15+ years

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