Sr. Director - Clinical Trial Plant Project Lead at Eli Lilly and Company

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.

Organization Overview:

LRL (Lilly Research Laboratories) Tech at Lilly unites science with technology to accelerate the LRL pipeline and deliver therapeutic innovations. As a member of the LRL Tech at Lilly organization, you will have the opportunity to work in highly technical and fast paced team in a scientifically challenging area responsible for delivering life changing medicines and treatments.  

Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. LRL has increasing needs for in-house manufacture of material for clinical supplies and will therefore construct a new campus to manufacture Clinical Trial (CT) Active Pharmaceutical Ingredient (API) to meet needs for an expanding portfolio (more and new areas), to accelerate development timelines, and to enhance supply chain robustness.

The brand-new facility will utilize the latest technology to augment the current supply chain for small molecules (SM), oligonucleotides, peptides, and Antibody Drug Conjugates (ADCs), monoclonal antibodies and bioconjugates, and add new capabilities including mRNA.

New site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don’t want to miss!

What You’ll be Doing:

Sr. Director - Clinical Trial Plant Project Lead will be responsible to ensure the delivery of the Tech at Lilly milestones (Infrastructure, Applications, Data Infrastructure and Architecture) to ensure the operational readiness on time with the schedule.

What You Should Bring:

• Ensure site operational readiness from IT perspective.  Site start up and integration of IT systems including:

• Infrastructure

• Enterprise Resource Planning

• Warehouse management & logistics coordination

• Manufacturing Execution System

• Biometric enrolment & authentication

• Data historian, Real Time Floor Tracking

• Data Integration

• Data Analytics

• Data Integrity

• Digital Plant

• Laboratory information managements

• CAPA systems

• Access Security

• Building Monitoring

• Risk Management

• MES (Manufacturing Execution System)

• Ensure full integrated schedule to deliver the Tech at Lilly is in place

• Member of the Site Leadership Team and work close with the PRD Tech at Lilly Sr Director Leader

• Benchmark on innovative solutions (external and internal to Lilly)

• Dynamically adapt road map to site evolution/strategic directions, and new trends/issues

• Partner cross functionally locally and globally to establish and implement site IT roadmap

• Responsible for maintaining a safe work environment.

• Responsible to manage Business Plan assessment, budget, capital.

• People

• Lead, coach, and develop members of the team.

• Support site recruiting building IT capability.

• Compliance

• Provide leadership in the development and execution of cGMP and/or improvement plans within the IT function and in support of site cGMP improvement plans.

• Define and execute IT inspection readiness activities.

• Ensure the full Tech at Lilly agenda is deliver under the DI expectations.

• Operational Excellence

• Provide prioritization and barrier removal

• Provide oversight of technical activities within the group

• Effectively encourage knowledge sharing and education

Your Basic Requirements:

• Bachelor's degree in scientific, business or IT-related field

• 10+ years IT leadership experience working in Pharma and Manufacturing and Quality, especially API Manufacturing

• 5+ years of strong experience with MES system implementations, Data Integration and Advance Analytics

• Regulatory compliance knowledge and experience (cGMP)

Additional Skills/Preferences:

• Demonstrated Learning agility and commitment to learning

• Demonstrated experience in leading the development of IT strategy for a business area

• Demonstrated ability to broadly influence senior leadership (Business and Tech at Lilly) across the organization

• Effective people and team leadership skills

• Ability to manage and contribute to multiple concurrent activities and adapt to changes in priorities.

• Ability to cross functionally collaborate

• Excellent written and oral communication skills

• Demonstrated creativity, analytical thinking, and the ability to troubleshoot and solve problems

• Experience in technical leadership of internal and external software development teams

• Knowledge of Agile framework and delivering in an Agile environment

• Knowledge of DevSecOps quality, project management and software development approaches

Additional Information:

• This role is located in Indianapolis, IN with a hybrid work model

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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