Eli Lilly and Company
Associate Director - TS/MS Device & Packaging
Eli Lilly and Company, Pleasant Prairie, Wisconsin, United States, 53158
Overview
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We put people first and seek individuals determined to make life better for people around the world. Position Brand Description
Join our elite team at Eli Lilly as we achieve drug product manufacturing and commercialization excellence. As the Associate Director of Technical Services/Manufacturing Science (TS/MS) in the Device and Packaging Network, you will lead operational excellence and drive technical innovation to the floor level. This role oversees the commercialization mission for the site, adheres to Manufacturing Standard for Operational Excellence (MSOE), and helps deliver the site’s functional, strategic, and business plans. Your leadership will mentor a technical staff and oversee device assembly processes to ensure control and capability. Key Objectives and Deliverables
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:
Lead and provide technical and effective process support services for production issue resolution and investigations, ensuring reliable solutions, safe execution, and regulatory compliance. Foster knowledge sharing and education within the team and with key internal partners to drive alignment and meet manufacturing goals. Innovation and Problem-Solving:
Foster a culture of innovation and creativity, encouraging team members to identify and drive improvement opportunities. This position may deliver equipment, lines, and supporting systems through technology transfers, control strategy development, or process validations. Oversee and implement the organization’s technology transfer agenda, ensuring seamless integration and replication of Site business and Quality Systems for Commercial Launch/Technical Agenda activities. Collaborative Leadership:
Represent the team on plant flow teams, influencing technical agendas and driving operational results. Collaborate closely with cross-functional teams, external partners, central functional organizations, and suppliers to drive alignment and resolve escalated issues. Resource Management:
Manage resources effectively, including workload optimization and staffing needs, to meet business objectives. Support Site Leadership to build a diverse and capable organization, supporting the areas of device assembly and packaging. Strategic Planning
Engage and support business plan objectives while tracking team performance and ensuring adequate resources are in place for successful implementation. Safety and Quality Culture:
Lead by example in building and driving a culture of safety first and quality always within the organization while removing barriers to team performance. Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc. Performance Metrics:
Develop and communicate department metrics to drive continuous improvement and ensure alignment to business goals. Develop team goals for safety, quality, and process effectiveness and efficiency. Regulatory Compliance:
Ensure adherence to current regulatory requirements, including cGMP standards, OSHA regulations, and environmental sustainability goals. Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections. Process Optimization:
Develop local processes and procedures to enhance efficiency and effectiveness, utilizing lean tools for success. Ensure process monitoring of critical parameters occur and reactions to signals/trends are appropriate to drive control, capability, productivity, and continuous improvement for the process. Minimum Requirements
Bachelor’s degree in Science, Engineering, or related field. 5+ years of manufacturing experience, pharmaceutical or regulated industry. 3+ years demonstrated leadership skills with a history of successful team development. Additional Preferences and Information
Knowledge of cGMP requirements in medical device manufacturing, highly preferred. Experience in device assembly and/or packaging. Understanding of basic requirements of regulatory agencies such as the FDA, DEKRA, and OSHA. Safety equipment (PPE) and precautions required in the manufacturing plant environment. Occasional travel may be required to support business needs. Previous equipment qualification and process validation experience. Previous experience with deviation and change management systems including Trackwise. Responsible for maintaining a safe work environment and supporting all health, safety, and environmental goals. Excellent interpersonal, written, and oral communication skills that demonstrate an ability to effectively communicate with all levels of the organization for decisions, influencing, coaching and mentoring. Compensation and Benefits
This position offers a unique opportunity to lead technical excellence in device manufacturing and commercialization. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $118,500 - $173,800. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). Lilly offers a comprehensive benefit program to eligible employees, including eligibility for medical, dental, vision and prescription drug benefits; flexible benefits; life insurance; and well-being benefits. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion. #WeAreLilly
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At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We put people first and seek individuals determined to make life better for people around the world. Position Brand Description
Join our elite team at Eli Lilly as we achieve drug product manufacturing and commercialization excellence. As the Associate Director of Technical Services/Manufacturing Science (TS/MS) in the Device and Packaging Network, you will lead operational excellence and drive technical innovation to the floor level. This role oversees the commercialization mission for the site, adheres to Manufacturing Standard for Operational Excellence (MSOE), and helps deliver the site’s functional, strategic, and business plans. Your leadership will mentor a technical staff and oversee device assembly processes to ensure control and capability. Key Objectives and Deliverables
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:
Lead and provide technical and effective process support services for production issue resolution and investigations, ensuring reliable solutions, safe execution, and regulatory compliance. Foster knowledge sharing and education within the team and with key internal partners to drive alignment and meet manufacturing goals. Innovation and Problem-Solving:
Foster a culture of innovation and creativity, encouraging team members to identify and drive improvement opportunities. This position may deliver equipment, lines, and supporting systems through technology transfers, control strategy development, or process validations. Oversee and implement the organization’s technology transfer agenda, ensuring seamless integration and replication of Site business and Quality Systems for Commercial Launch/Technical Agenda activities. Collaborative Leadership:
Represent the team on plant flow teams, influencing technical agendas and driving operational results. Collaborate closely with cross-functional teams, external partners, central functional organizations, and suppliers to drive alignment and resolve escalated issues. Resource Management:
Manage resources effectively, including workload optimization and staffing needs, to meet business objectives. Support Site Leadership to build a diverse and capable organization, supporting the areas of device assembly and packaging. Strategic Planning
Engage and support business plan objectives while tracking team performance and ensuring adequate resources are in place for successful implementation. Safety and Quality Culture:
Lead by example in building and driving a culture of safety first and quality always within the organization while removing barriers to team performance. Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc. Performance Metrics:
Develop and communicate department metrics to drive continuous improvement and ensure alignment to business goals. Develop team goals for safety, quality, and process effectiveness and efficiency. Regulatory Compliance:
Ensure adherence to current regulatory requirements, including cGMP standards, OSHA regulations, and environmental sustainability goals. Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections. Process Optimization:
Develop local processes and procedures to enhance efficiency and effectiveness, utilizing lean tools for success. Ensure process monitoring of critical parameters occur and reactions to signals/trends are appropriate to drive control, capability, productivity, and continuous improvement for the process. Minimum Requirements
Bachelor’s degree in Science, Engineering, or related field. 5+ years of manufacturing experience, pharmaceutical or regulated industry. 3+ years demonstrated leadership skills with a history of successful team development. Additional Preferences and Information
Knowledge of cGMP requirements in medical device manufacturing, highly preferred. Experience in device assembly and/or packaging. Understanding of basic requirements of regulatory agencies such as the FDA, DEKRA, and OSHA. Safety equipment (PPE) and precautions required in the manufacturing plant environment. Occasional travel may be required to support business needs. Previous equipment qualification and process validation experience. Previous experience with deviation and change management systems including Trackwise. Responsible for maintaining a safe work environment and supporting all health, safety, and environmental goals. Excellent interpersonal, written, and oral communication skills that demonstrate an ability to effectively communicate with all levels of the organization for decisions, influencing, coaching and mentoring. Compensation and Benefits
This position offers a unique opportunity to lead technical excellence in device manufacturing and commercialization. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $118,500 - $173,800. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). Lilly offers a comprehensive benefit program to eligible employees, including eligibility for medical, dental, vision and prescription drug benefits; flexible benefits; life insurance; and well-being benefits. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion. #WeAreLilly
#J-18808-Ljbffr