Associate/Senior Associate Material Coordinator, Product Delivery

at  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.
At Eli Lilly Cork, 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 45,000 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 patients around the world.
Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond. Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
Position Brand Description:
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 Group and Operations Group. The Operations Group is composed of NDP Manufacturing Material Coordinators.
The Material Coordinator is responsible for NDP manufacturing in the plant based on the schedule generated by the NDP Mfg. Plant Planner. The Material Coordinator works closely with the NDP Manufacturing Plant Planner and CT Manufacturing Technical Group, and is responsible for the execution of the manufacturing runs for each molecule. The Associate Consultant Material Coordinator is responsible and purchase order conversions from purchase requisition.

Position Responsibilities:

• Partners with the NDP Mfg. Plant Planner to understand schedule and priorities; partner with quality and Collaboration Partner (CP) for order execution activities.
• 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 NDP to be produced; releases POs; enters appropriate WBS 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 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 list and notify the CP when shipment of NDP is needed; ensures necessary import approvals are in place prior to shipment execution; creates outbound delivery if needed and performs goods issue in SAP on behalf of the CP as necessary.
• Provides FFU determinations, 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 follow procedures 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).
• Author’s relevant non-technical change controls for CT Manufacturing Operations space.
• Participates in departmental site self assessments and relevant audits.

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 CPs 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.

• Partners with the NDP Mfg. Plant Planner to understand schedule and priorities; partner with quality and Collaboration Partner (CP) for order execution activities.
• 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 NDP to be produced; releases POs; enters appropriate WBS 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 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 list and notify the CP when shipment of NDP is needed; ensures necessary import approvals are in place prior to shipment execution; creates outbound delivery if needed and performs goods issue in SAP on behalf of the CP as necessary.
• Provides FFU determinations, 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 follow procedures 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).
• Author’s relevant non-technical change controls for CT Manufacturing Operations space.
• Participates in departmental site self assessments and relevant audits