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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.

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 35,000 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 API molecules located in Lebanon, IN (Lilly Lebanon API). 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 startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.

Position Description:

The CMC Project Management Professional is responsible for overseeing the Chemistry, Manufacturing, and Controls (CMC) activities for our pharmaceutical products. This role requires a strong background in managing pharmaceutical projects and new facility start-ups, with a focus on ensuring compliance with Good Manufacturing Practices (GMPs). This position will lead the creation, development, communication, and implementation of integrated CMC plans for assets from portfolio entry to global submissions/approvals and launch. The Project Manager is expected to have commercial product manufacturing knowledge, leadership and business acumen, and project management skills. The Project Manager must have strong relationship and communication skills and an ability to influence team members and leadership at manufacturing sites, within core Manufacturing and Quality (M&Q) functions, and within the relevant Business Unit. A person in this position has a CMC and/or manufacturing background and is expected to apply project management principles as guided by PMBOK, including robust risk management for cross-functional teams.

Key Objectives/Deliverables

+ Work closely with technical leadership to actively manage pharmaceutical manufacturing projects, facilitate project reviews to ensure processes are in control and capable, and lead teams to ensure on time delivery of projects.

+ Responsible for project schedule for tech transfer of products across sites within Eli Lilly, including process validation and commercialization of manufacturing processes for active pharmaceutical ingredients.

+ Manage the planning, coordination, and execution of new facility start-up activities, including process and cleaning validation.

+ Work closely with SMEs in Process Chemistry, Peptide Synthesis/Purification, Materials, Engineering, Manufacturing and Quality to manage impact of project changes.

+ Maintain technical knowledge of project.

+ Implement and improve standard business management processes such as capacity/budget estimation, planning, allocation, and tracking. Forecast resource needs and manage allocated budgets.

+ Identify, propose, and support solutions for operational problems and technical challenges. Ensure project management is appropriately represented and involved in cross-functional process improvement projects.

+ Ensure all CMC activities comply with GMP regulations and guidelines, maintaining high standards of quality and safety.

Project Management expertise:

+ Applies knowledge of project management tools and processes.

+ Drives team decision making process to resolve project issues. Able to influence decisions at all levels of the company. Demonstrated ability to influence without authority.

+ Demonstrated ability to work with ambiguity and to "connect the dots"

+ Develops a risk management strategy for individual projects and ensures contingency plans are developed.

+ Evaluates new requests for manufacturing or product changes for project impact.

+ Manages change control process for the project.

+ Drives development of draft operational plans and ensures that data is available to allow evaluation of new projects.

+ Provide CMC expertise and leadership with Business Unit, Development and M&Q partners.

+ Ensure team activities meet priority needs of BU and M&Q. Ensure technical activities meet rigorous standards and align with regulatory and supply chain requirements.

+ Support CM&C teams in developing strategies and implementing operational plans to deliver API, registration stability lots, and/or other materials required to support/implement a new facility start-up project.

Basic Requirements:

+ Bachelor's in a scientific, engineering, or related relevant field

+ 3+ years of work experience with basic project management tools and processes (e.g. management of integration, scope, time, cost, quality, human resources, communications, risk and procurement as defined by Project Management Body of Knowledge).

+ 5+ years of pharmaceutical experience in one or more of the following areas: drug discovery/process development, CT material supply chain, CMC, quality, or commercial manufacturing.

Preferences:

+ Experience in Operations, TS/MS, QAQC, Regulatory, or Supply Chain within pharmaceutical manufacturing.

+ Green Belt or Black Belt experience

+ Technical transfer experience

+ Masters in Project Management, PMP certification, PE or MBA.

+ Demonstrated successful leadership of cross-functional teams.

+ Demonstrated ability to identify and prioritize problems, develop and implement solutions.

+ Strong interpersonal and teamwork skills.

+ Strong self-management and organizational skills.

+ Oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization.

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

$76,500 - $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.

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