Associate Director – TSMS Device, Assembly, and Packaging
Scorpion Therapeutics, Pleasant Prairie, Wisconsin, United States, 53158
Role Summary
The Technical Services/Manufacturing Science (TS/MS) Associate Director leads staffing, training, and leadership of the TS/MS Device Assembly and Packaging (DAP) group. The TS/MS group provides technical leadership for device assembly and packaging operations for commercially manufactured products targeted for transfer to the Lilly Kenosha County site. The Associate Director supports day-to-day TS/MS activities and plans for the 3–6 month horizon, and coaches others in safety, quality, technical capability, and continuous improvement. Responsibilities
Understand the scientific principles required for manufacturing products in area of influence (DAP) including the interaction of chemistry, equipment, components, and container closure systems. Support Site Leadership to build a diverse and capable TS/MS organization, with a focus on supporting the areas of device assembly and packaging. Deliver equipment, lines, and supporting systems through technology transfer, process validation, and control strategy development. Provide leadership and develop objectives to deliver business plan goals as it relates to safety, quality, and process effectiveness and efficiency. Determine staffing and resource needs to support site TS/MS requirements. Maintain metrics to measure performance against business objectives and make necessary changes to improve performance. Provide technical guidance to the TS/MS group. Participate in the development and implementation of strategies associated with the area sponsoring or supporting the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA). Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections. Understand and influence the manufacturing control strategy for the various operational areas. Manage external contracts/resources and project management resources, as needed. Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc. Work cross-functionally with the area process teams for metrics reviews, operational support, and issue / deviation management. Drive control, capability, productivity, and continuous improvement for the process. Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Serve as technical interface external to the Kenosha site. Work within or lead cross-functional teams in positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives. Network and collaborate with global and other parenteral sites to understand best practices, share knowledge, and participate in tactical and strategic business planning. Ensure a safe working environment through compliance with safety rules and improving safety culture by actively participating in safety-related activities. Qualifications
Required:
Minimum 1 year of management or leadership experience, including leading or working effectively with a cross functional group Minimum 5 years of regulated industry experience
Skills
Strong technical aptitude and ability to train and mentor others Excellent interpersonal, written, and oral communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization Solid understanding of basic requirements of regulatory agencies such as the FDA, DEKRA, and OSHA. Experience supporting cGMP manufacturing (specifically within operations, technical services/MSAT, quality assurance, etc.) Previous experience with combination products, device assembly, pharmaceutical packaging Previous facility or area start up experience Previous equipment qualification and process validation experience Previous experience with highly automated equipment Previous experience with deviation and change management systems including: Trackwise, Veeva, MasterControl. Education
BS, MS, or Doctorate in Packaging Science, Mechanical Engineering, Pharmaceutical Sciences, Biochemical Engineering, Chemical Engineering, or other related scientific discipline Additional Requirements
Role is Monday through Friday based. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required.
#J-18808-Ljbffr
The Technical Services/Manufacturing Science (TS/MS) Associate Director leads staffing, training, and leadership of the TS/MS Device Assembly and Packaging (DAP) group. The TS/MS group provides technical leadership for device assembly and packaging operations for commercially manufactured products targeted for transfer to the Lilly Kenosha County site. The Associate Director supports day-to-day TS/MS activities and plans for the 3–6 month horizon, and coaches others in safety, quality, technical capability, and continuous improvement. Responsibilities
Understand the scientific principles required for manufacturing products in area of influence (DAP) including the interaction of chemistry, equipment, components, and container closure systems. Support Site Leadership to build a diverse and capable TS/MS organization, with a focus on supporting the areas of device assembly and packaging. Deliver equipment, lines, and supporting systems through technology transfer, process validation, and control strategy development. Provide leadership and develop objectives to deliver business plan goals as it relates to safety, quality, and process effectiveness and efficiency. Determine staffing and resource needs to support site TS/MS requirements. Maintain metrics to measure performance against business objectives and make necessary changes to improve performance. Provide technical guidance to the TS/MS group. Participate in the development and implementation of strategies associated with the area sponsoring or supporting the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA). Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections. Understand and influence the manufacturing control strategy for the various operational areas. Manage external contracts/resources and project management resources, as needed. Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc. Work cross-functionally with the area process teams for metrics reviews, operational support, and issue / deviation management. Drive control, capability, productivity, and continuous improvement for the process. Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Serve as technical interface external to the Kenosha site. Work within or lead cross-functional teams in positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives. Network and collaborate with global and other parenteral sites to understand best practices, share knowledge, and participate in tactical and strategic business planning. Ensure a safe working environment through compliance with safety rules and improving safety culture by actively participating in safety-related activities. Qualifications
Required:
Minimum 1 year of management or leadership experience, including leading or working effectively with a cross functional group Minimum 5 years of regulated industry experience
Skills
Strong technical aptitude and ability to train and mentor others Excellent interpersonal, written, and oral communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization Solid understanding of basic requirements of regulatory agencies such as the FDA, DEKRA, and OSHA. Experience supporting cGMP manufacturing (specifically within operations, technical services/MSAT, quality assurance, etc.) Previous experience with combination products, device assembly, pharmaceutical packaging Previous facility or area start up experience Previous equipment qualification and process validation experience Previous experience with highly automated equipment Previous experience with deviation and change management systems including: Trackwise, Veeva, MasterControl. Education
BS, MS, or Doctorate in Packaging Science, Mechanical Engineering, Pharmaceutical Sciences, Biochemical Engineering, Chemical Engineering, or other related scientific discipline Additional Requirements
Role is Monday through Friday based. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required.
#J-18808-Ljbffr