Associate Director TSMS Device, Assembly, and Packaging

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 36 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.

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