Associate Director – TS/MS Central Team

Lilly • Indianapolis, IN

1d • $123,000 - $180,400 • Onsite

About The Position

The IPM TS/MS Central Team is a new team that provides centralized TS/MS support for both the Insulin and Syringe Plants. This group will own Components, Materials, Annual Product Review, and Visual Inspection Qualifications. The Associate Director, TS/MS Central Team role will report directly to the IPM TS/MS Associate Vice President and will be responsible for leading and mentoring the technical staff. This role is responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals. The position drives a safety and quality culture within the organization, understands the scientific principles required for manufacturing products in the area of influence including the interaction of the chemistry, equipment, materials, aseptic processes, and container closure systems. The role provides technical guidance to the TS/MS group, understands and influences the manufacturing control strategy for the various operational areas, and drives control, capability, productivity, and continuous improvement for the process. The Associate Director will review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, APRs, etc. They will work cross-functionally with the area process teams for metrics reviews, operational support, and issue / deviation management. This role provides oversight for interactions with external component and material suppliers/vendors and engaging directly as needed; partnering with Procurement and Materials Management QA to support GMP supplier qualification activities. The Associate Director partners within TS/MS and across functional disciplines to influence and implement the technical agenda, site business plan objectives and GMP Quality Plan objectives. They will network and collaborate with global and other parenteral sites to understand best practices, share knowledge, and participate in tactical and strategic business planning. The role supports site inspection readiness and execution, and may have direct interaction with Regulatory Agencies during site inspections. Performance management and development of staff is also a key responsibility.

Requirements

• Bachelor’s Degree in scientific disciplines of Material Science, Chemistry, Biology, Pharmacy, Engineering.
• 5+ years of pharmaceutical manufacturing experience in TS/MS or associated disciplines such as Manufacturing, Quality Control, Quality Assurance, or Engineering.
• 3+ years of experience leading teams
• 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 and 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.

Nice To Haves

• Strong technical aptitude and ability to train and mentor others
• Proven Teamwork and interpersonal skills
• Problem solving and independent decision-making skills
• Oral and written communication skills that demonstrate an ability to effectively (e.g., clearly, succinctly) communicate with all levels of the organization.
• Ability to influence diverse groups
• Previous experience with deviation and change management systems
• Experience interacting with external vendors, including technical discussions, issue resolution, and change notifications.
• Understanding of GMP supplier qualification processes (e.g., risk-based assessment, audits, quality agreements, and ongoing supplier performance monitoring).

Responsibilities

• Report directly to the IPM TS/MS Associate Vice President and will be responsible for leading and mentoring the technical staff.
• Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
• Drive safety and quality culture within the organization
• Understand the scientific principles required for manufacturing products in area of influence including the interaction of the chemistry, equipment, materials, aseptic processes, and container closure systems.
• Provide technical guidance to the TS/MS group.
• Understand and influence the manufacturing control strategy for the various operational areas.
• Drive control, capability, productivity, and continuous improvement for the process.
• Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, APRs, etc.
• Work cross-functionally with the area process teams for metrics reviews, operational support, and issue / deviation management.
• Provide oversight for interactions with external component and material suppliers/vendors and engaging directly as needed; partner with Procurement and Materials Management QA to support GMP supplier qualification activities.
• Partner within TS/MS and across functional disciplines to influence and implement the technical agenda, site business plan objectives and GMP Quality Plan objectives
• Network and collaborate with global and other parenteral sites to understand best practices, share knowledge, and participate in tactical and strategic business planning.
• Support site inspection readiness and execution. This role may have direct interaction with Regulatory Agencies during site inspections.
• Performance management and development of staff

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager