Associate Director – TS/MS Central Team

Eli Lilly and Company • 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 Monday through Friday based but requires flexibility in providing support to 24/7 operations, with occasional extended hour and/or off-hour work potentially required. Minimal travel is expected.

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 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.

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

• Leading and mentoring the technical staff.
• Maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
• Driving safety and quality culture within the organization.
• Understanding the scientific principles required for manufacturing products in the area of influence, including the interaction of chemistry, equipment, materials, aseptic processes, and container closure systems.
• Providing technical guidance to the TS/MS group.
• Understanding and influencing the manufacturing control strategy for the various operational areas.
• Driving control, capability, productivity, and continuous improvement for the process.
• Reviewing and approving GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, APRs, etc.
• Working cross-functionally with the area process teams for metrics reviews, operational support, and issue / deviation management.
• Providing 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.
• Partnering within TS/MS and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
• Networking and collaborating with global and other parenteral sites to understand best practices, share knowledge, and participate in tactical and strategic business planning.
• Supporting site inspection readiness and execution.
• Direct interaction with Regulatory Agencies during site inspections may occur.
• Performance management and development of staff.

Benefits

• Company bonus (depending, in part, on company and individual performance).
• Company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for 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