BioSpace
Overview
Associate Director - TS/MS Device & Packaging. Join Lilly as we achieve drug product manufacturing and commercialization excellence. This role leads the Technical Services/Manufacturing Science (TS/MS) function in the Device and Packaging Network to drive operational excellence, technical innovation, and the site’s commercialization mission, aligning with Manufacturing Standard for Operational Excellence (MSOE). The incumbent mentors a technical staff and oversees device assembly processes to ensure control and capability. Responsibilities
Empowerment through Development: Lead, mentor, coach, and develop staff, fostering a culture of continuous improvement and operational excellence for safety, quality, and technical capability. Technical Excellence: Provide technical and effective process support for production issue resolution and investigations, ensuring reliable solutions, safe execution, and regulatory compliance. Foster knowledge sharing with internal partners to drive alignment and meet manufacturing goals. Innovation and Problem-Solving: Foster a culture of innovation, drive improvement opportunities, support equipment lines and systems through technology transfers, control strategy development, or process validations. Oversee the organization’s technology transfer agenda and ensure integration with Site business and Quality Systems for Commercial Launch/Technical Agenda activities. Collaborative Leadership: Represent the team on plant flow teams, influence technical agendas, and drive operational results. Collaborate with cross-functional teams, external partners, central functional organizations, and suppliers to resolve escalated issues. Resource Management: Manage workload and staffing to meet business objectives. Support Site Leadership in building a diverse and capable organization focused on device assembly and packaging. Strategic Planning
Safety and Quality Culture: Lead by example in safety and quality, review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports. Performance Metrics: Develop and communicate department metrics to drive continuous improvement and align with business goals. Set team goals for safety, quality, and process effectiveness and efficiency. Regulatory Compliance: Ensure adherence to current regulatory requirements (e.g., cGMP), support site inspection readiness and execution. Interact with Regulatory Agencies as needed. Process Optimization: Develop local processes and procedures to enhance efficiency, using lean tools. Monitor critical parameters and respond to signals/trends to drive control, capability, productivity, and continuous improvement. Minimum Requirements
Bachelor’s degree in Science, Engineering, or related field. 5+ years of manufacturing experience in pharmaceutical or regulated industry. 3+ years of demonstrated leadership with a track record of successful team development. Additional Preferences And Information
Knowledge of cGMP requirements in medical device manufacturing is highly preferred. Experience in device assembly and/or packaging. Understanding of regulatory requirements from agencies such as FDA, DEKRA, OSHA. Safety equipment (PPE) and precautions required in the manufacturing environment. Occasional travel may be required. Experience with equipment qualification and process validation; deviation and change management systems (e.g., Trackwise). Commitment to maintaining a safe work environment and supporting health, safety, and environmental goals. Strong interpersonal, written, and oral communication skills to interact with all levels of the organization.
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Associate Director - TS/MS Device & Packaging. Join Lilly as we achieve drug product manufacturing and commercialization excellence. This role leads the Technical Services/Manufacturing Science (TS/MS) function in the Device and Packaging Network to drive operational excellence, technical innovation, and the site’s commercialization mission, aligning with Manufacturing Standard for Operational Excellence (MSOE). The incumbent mentors a technical staff and oversees device assembly processes to ensure control and capability. Responsibilities
Empowerment through Development: Lead, mentor, coach, and develop staff, fostering a culture of continuous improvement and operational excellence for safety, quality, and technical capability. Technical Excellence: Provide technical and effective process support for production issue resolution and investigations, ensuring reliable solutions, safe execution, and regulatory compliance. Foster knowledge sharing with internal partners to drive alignment and meet manufacturing goals. Innovation and Problem-Solving: Foster a culture of innovation, drive improvement opportunities, support equipment lines and systems through technology transfers, control strategy development, or process validations. Oversee the organization’s technology transfer agenda and ensure integration with Site business and Quality Systems for Commercial Launch/Technical Agenda activities. Collaborative Leadership: Represent the team on plant flow teams, influence technical agendas, and drive operational results. Collaborate with cross-functional teams, external partners, central functional organizations, and suppliers to resolve escalated issues. Resource Management: Manage workload and staffing to meet business objectives. Support Site Leadership in building a diverse and capable organization focused on device assembly and packaging. Strategic Planning
Safety and Quality Culture: Lead by example in safety and quality, review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports. Performance Metrics: Develop and communicate department metrics to drive continuous improvement and align with business goals. Set team goals for safety, quality, and process effectiveness and efficiency. Regulatory Compliance: Ensure adherence to current regulatory requirements (e.g., cGMP), support site inspection readiness and execution. Interact with Regulatory Agencies as needed. Process Optimization: Develop local processes and procedures to enhance efficiency, using lean tools. Monitor critical parameters and respond to signals/trends to drive control, capability, productivity, and continuous improvement. Minimum Requirements
Bachelor’s degree in Science, Engineering, or related field. 5+ years of manufacturing experience in pharmaceutical or regulated industry. 3+ years of demonstrated leadership with a track record of successful team development. Additional Preferences And Information
Knowledge of cGMP requirements in medical device manufacturing is highly preferred. Experience in device assembly and/or packaging. Understanding of regulatory requirements from agencies such as FDA, DEKRA, OSHA. Safety equipment (PPE) and precautions required in the manufacturing environment. Occasional travel may be required. Experience with equipment qualification and process validation; deviation and change management systems (e.g., Trackwise). Commitment to maintaining a safe work environment and supporting health, safety, and environmental goals. Strong interpersonal, written, and oral communication skills to interact with all levels of the organization.
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