Associate Director - TSMS PAR

Technical Services/Manufacturing Science Associate Director

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Responsibilities:

The Technical Services/Manufacturing Science (TS/MS) Associate Director is responsible for the staffing, training, and leadership of the TS/MS group. The TS/MS group provides technical leadership for PAR (formulation, filling, visual inspection) or DAP (device assembly, packaging) operations for commercially manufactured products targeted for transfer to the Concord site.

The Associate Director will be responsible for supporting the day-to-day TS/MS activities as well as planning for the 3-6-month horizon. The TS/MS Associate Director is expected to lead by example and provide coaching to others in the areas of safety, quality, technical capability, and continuous improvement.

Key Objectives/Deliverables:

• Understand the scientific principles required for manufacturing products in area of influence (PAR or DAP) including the interaction of the chemistry, equipment, components, aseptic processes, 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 Concord 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.

Basic Qualifications:

• BS, MS, or Doctorate in Packaging Science, Mechanical Engineering, Pharmaceutical Sciences, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
• 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
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Skills/Preferences:

• 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…