Hybrid Associate Director– CT Parenteral Ops presso Lilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The Clinical Trial (CT) manufacturing organization is responsible for the make and release of parenteral drug product, supporting the Clinical Supply and Delivery (CSD) organization and their objectives. The facility is a manufacturing plant specializing in aseptic processing and sterile medicines production for clinical trials, along with the associated technical data and documentation to support GMP activities. The plant is located within Building 358 (B358) in Indianapolis, IN at the Lilly Technology Center North campus.

This position is within the Operations (OPS) team of the manufacturing organization. The Associate Director will be expected to anticipate and resolve key technical, operational, and business problems as part of drug product manufacturing.  They will provide a leadership role in operational excellence, manage process improvements and associated large projects, lead deviation investigations, own operational learning & development, and acting as a liaison between operations and multiple support groups.  The associate director will effectively collaborate with both internal and external partners to achieve desired results.

Key Objectives/Deliverables:

• Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
• Provide leadership and operational expertise within Parenteral Manufacturing processes.
• Lead training curricula development and qualification programs across multiple workstreams (Operations, TS/MS, Engineering, Sterility Assurance)
• Lead Deviation investigations and drive business wide CAPA’s
• Investigate problems, conduct root cause analysis, and implement countermeasures
• Identify and manage improvement projects
• Create, execute and / or Review change controls
• Development and monitoring of KPI’s
• Ensure consistency of operations through active engagement on the shop floor and through Gemba walks and Practice vs. Procedure evaluations
• Ensure cross functional collaboration between operations, engineering, quality, supply chain and maintenance to meet key metrics and deliverables for the area
• Drive projects for improvement
• Aid with batch/product approvals, issue resolution and production schedule development and execution
• Act as a backup to Associate Director (M2)and Planner/Scheduler
• Lead area tours to support business reviews, regulatory audits, or network collaboration
• Represent operations in regulatory inspections and audits
• Own Access control to operations owned areas and software
• Complete safety audits as part of the Safety Committee
• Support onboarding of new personnel

Basic Requirements:

• Experience: 8+ years of GMP/Parenteral Operations experience or support.

Additional Preferences:

• Previous leadership/supervisory experience.
• Career interests in operations leadership.
• Experience researching and replicating the work of other areas / facilities.
• Experience working hands on with equipment and processes and to train other technical staff and operators
• Excellence in; electronic, written, and oral communication skills
• Strong technical aptitude as demonstrated through previous work or educational accomplishments
• Ability To Work 8 Hours Per Day Monday Through Friday With Overtime As Required To Meet Key Objectives.
• Ability To Work And Gown In A Cleanroom (Grade C, Iso 8) Environment.

Education Requirements:

• Bachelors’ Degree in Engineering or Science

Additional Information/Requirements:

• Monday through Friday Day Shift
• Some work outside of core hours may be required to enable the delivery of the portfolio.
• Some domestic and/or international travel required.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$114,000 - $167,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

Candidarsi ora