"Alerted.org

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.

_Lilly is currently constructing an advanced manufacturing facility for production of Active Pharmaceutical Ingredients (API) located in Lebanon, IN. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations._

Main Purpose and Objectives of Position:

The Senior Director Engineering is directly responsible for managing the API Plant (either Small Molecule or Peptide) engineering function and ensuring it has the necessary capacity, capability and leadership structures in place to deliver the plant engineering deliverables in support of the manufacturing plan. The Senior Director Engineering provides administrative and technical leadership for the plant engineering function including process engineering, process control and automation, and works with the Site Central Engineering team for maintenance, utilities, plant and project engineering, and engineering competencies.

The Senior Director Engineering is a member of the Lilly Lebanon API Manufacturing Plant Lead Team. The Lead Team has collective responsibility to develop and implement the strategic direction, organizational capability and management of the plant. Primarily, the members of the team drive the plant toward achieving long term business objectives; they continuously develop the business and the organization for the future bearing in mind corporate objectives and the continuously changing external environment; and they manage issues that span multiple teams in the organization and extend into the broader corporate/external context.

In the project delivery phase and startup phase of the project, the Plant Lead Team roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the plant culture. This will require significant collaboration, creativity and resilience as the plant grows to full scale GMP manufacturing through start up.

Key Responsibilities for this role include:

Pre-Startup and Startup Phase

+ Support the safe, on time, and successful startup, process validation, and successful pre approval inspections.

+ Be a collaborative, inclusive, energetic leader and support the broader lead team.

+ Build the organization with the necessary capability, capacity and culture to operate this facility to the highest standards of safety, quality, and operational excellence.

+ Defines the Small Molecule or Peptide engineering priorities & roadmap in order to develop and implement the systems and processes needed to run the plant. This includes leveraging existing Lilly knowledge where necessary, but also incorporating external experiences and learning.

+ Serve as a key member of the Plant Lead Team, ensuring cross functional excellence throughout project delivery and startup.

+ Support safe delivery of all aspects of the plant; serve as a key member of the plant HSE governance.

+ Support the project team to deliver the facility as the end user. Providing feedback and support on design decisions, commissioning strategies, startup plan, etc. Collaborate to ensure the right decisions are made to meet project deliverables and longer term strategic goals for the site.

+ Develop and adapt organizational structure to provide correct and capable resources and management to deliver the plant to a full scale GMP manufacturing scale.

+ Ensure the systems are in place and executed to establish the initial qualified and safe state for equipment, processes, utilities and facilities

+ Build technical relationships with the relevant corporate departments and sponsors strategic corporate initiatives at a plant level.

Post Startup

+ Continue to define and support engineering priorities & roadmap; integrate the functional agenda with plant and site priorities.

+ Ensure the plant is in compliance with corporate standards and policies for the engineering function, including applicable environmental, safety, and quality requirements.

+ Have external focus, benchmark best practices across network and externally.

+ Ensure equipment, processes, utilities and facilities remain and operate in a qualified and safe state.

+ Work with the Site Central Engineering team to ensure that equipment maintenance and utilities operations are performed and documented to the highest standards of safety and quality, and assist with managing the plant investment processes for assets (planning, prioritization, resourcing, project management, capital accounting and reporting), the development and delivery of the capital investment plan in accordance with the plant objectives for new products, recapitalization of assets, and facility modernization.

+ Ensure that a robust control system exists to manage the business, identify compliance issues and escalate issues appropriately is established and maintained.

+ Develop the future management and technical leadership for the plant and for potential global assignments.

Minimum Requirements:

+ Bachelor's degree in an engineering discipline

+ Minimum 10 years of experience in a leadership role managing teams within the pharmaceutical industry

+ Must possess knowledge and understanding of cGMPs and how they apply to manufacturing operations.

Additional Preferences:

+ Experience in API manufacturing including a Process Safety Management program is preferred.

+ Strong ability to form effective relationships at all levels. This candidate should be able to work closely with the Plant and Site Leadership team to ensure alignment with corporate objectives and internal decision making processes, and be able to connect and communicate effectively with all levels of the organization on site.

+ Should have a demonstrated track record of successfully developing, managing and executing projects from start to finish on time and within budget with high performance standards that ensure customer satisfaction.

+ Should have experience developing and managing extremely talented, engaged and high performing teams with a focus on building strong team cultures to ensure a safe and successful work environment.

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

$163,500 - $239,800

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