"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.

Organization Overview:

The CT Manufacturing organization is responsible for the on time delivery of drug product for supporting clinical trials (Phase 1 through 4) as well as the associated technical information deliverables. CT Manufacturing accomplished either externally at

approved Third Party Contract Manufacturing sites, both in the US and OUS, or internally at Lilly commercial manufacturing facilities. The CT manufacturing organization consists of two components: Technical Representative Group and Operations Group. The Operations Group is composed of NDP Manufacturing Material Coordinators and Plant Planners.

The Material Coordinator is responsible for New Drug Product manufacturing in the plant based on the schedule generated by the New Drug Product Mfg. Plant Planner. The Material Coordinator works closely with the New Drug Product Manufacturing Plant Planner and CT Manufacturing Tech Rep and is responsible for the execution of the manufacturing runs for each molecule. The Material Coordinator is responsible and purchase order conversions from purchase requisition.

Responsibilities:

• Partners with the New Drug Product Mfg. Plant Planner to understand schedule and priorities; partner with quality and Collaboration

Partner (CP) for order execution activities.

• Participate in demand planning conversations as needed.

• Accountable for MRP (Manufacturing Resource Planning) actions from the point of purchase order creation through

successful incoming receipt and batch disposition.

• Coordinate activities and communicate timing on incoming and outgoing shipment schedules.

• Understand and monitor timing of orders and impact to overall supply plan and develop mitigation plans to reduce impact to supply as needed.

• Monitors component inventory levels at the CP and creates deliveries to replenish as needed.

• Converts manufacturing purchase requisitions to subcontracting purchase orders; enters order details; creates SAP batch

for New Drug Product to be produced; releases POs; enters appropriate PRISM I/O code on CO production order.

• In partnership with CT Tech Rep, resolves order-specific issues with the CP and manage deviation investigations as

needed (e.g., Level 1 temperature excursion deviations).

• Accountable for document exchange with the CP (e.g., ticket copies, CT packet, CoA's and other supporting documents

regarding raw materials and components).

• Completes steps within a business work center on the quality inspection plan.

• Manages shipments of CP samples pulled during manufacturing order.

• Creates sales order when needed for non-SAP customer.

• Upon completion of manufacturing order, performs SAP goods receipt; reconciles any discrepancies between goods

receipt and CP invoice; completes business work center items to ensure all work is done.

• Communicates stock availability to the CP; monitors delivery due dates and notify the CP when shipment of New Drug Product is

needed based on supply plan; ensures necessary import approvals are in place prior to shipment execution; creates out-

bound delivery if needed and performs goods issue in SAP on behalf of the CP as necessary.

• Maintain SAP data related to orders in support of the organization and support improvements monitored through

monthly metric tracking.

• Provides FFU determinations, TOE calculations and SSS verification as needed.

• Conducts periodic inventory reconciliations.

• Responsible for a) oral periodic batch sampling and re-evaluation to extend material dating or b) parenteral impact

assessment for batches in inventory as a result of change in material allowable dating period, or for material destruction.

• GMP Compliance

+ Must be knowledgeable on how to apply GMPs in a clinical trial environment. Authors, reviews and followprocedures applicable to the CT business. In addition, individual training plans must be kept up to date.

• Quality Assurance

+ Authors appropriate deviations except level 2/3 deviations which are handled by Technical Representatives **,** (e.g., L1 temperature excursions, shipping, samples).

+ Participates in departmental site self-assessments and relevant audits.

Basic Requirements:

Education:

• Minimum of High School Diploma or GED

• B.S. in Pharmacy, Pharmaceutical Sciences, Chemical/Biochemical Engineering or related field is preferred. Others are

acceptable with relevant work experience.

Leadership:

• Excellent oral and written communication skills with the ability to interact well in a team environment and across

cultures.

• Ability to develop/manage relationships with CPs

• Ability to collaborate with partners around the world

• Initiative and ability to handle multiple projects in an independent fashion

• Ability to use and apply multiple computer applications.

• Excellent organization and self-management skills.

• High initiative, flexible and positive attitude.

• Ability to respond to changing priorities and short lead times.

Technical:

• Experience in managing inventory/supplies or complex supply chains.

• Knowledge of clinical trial manufacturing operations.

• High degree of accuracy with work and attention to details.

• Ability to proactively identify problems and work toward a solution.

• Minimum 1 year in a GMP environment.

Additional Preferences:

• Experience with oral and/or parenteral product manufacturing preferred.

• Prior experience with SAP.

• Proficient in MS Teams.

• Prior with planning manufacturing activities.

• Proven ability to work in an environment with frequently changing priorities.

Additional Information/Requirements:

• Some work outside of core hours may be required to support the portfolio.

• Limited domestic travel may be required to support the portfolio (<5%).

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

$63,000 - $140,800

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