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Lilly Associate Director, Molecule Planner in Cork, Ireland

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.

Organization Overview:

The Clinical Supply Planning and Execution (CSP&E) function is accountable for partnering with drug development teams, clinical, PRD, and the broader Product Delivery Organization to enable innovative supply chain solutions and speed the delivery of clinical trial materials for patients. This is accomplished by planning and scheduling via a Material Requirements Planning (MRP) system (SAP).

The Molecule Planner is part of the CTSP&E function and is responsible to lead cross-functional CT Material Operations Teams and use SAP to develop supply plans for their accountable molecules/studies.  The Molecule Planner partners with the Clinical Trial Supply Managers and Supply Advisors to understand key elements of the molecule/study plans and ensures the supply plan is appropriate to meet all demands and dating requirements for the molecule/study. The Molecule Planner is responsible for creating and maintaining P-reqs and Planned Orders for each Plant and partnering with the Plant Planners to understand any issues with schedules, yields or delivery issues that may impact the supply plan.

The supply plan generated and decisions made by the Molecule Planner have far reaching, global impact.  The supply plan drives execution activities across all Product Delivery, other external functions, and internal and external manufacturing, packaging, and distribution plants around the globe.  The plan also directly impacts global Business Unit budgets and Lilly’s ability to meet Corporate clinical trial cycle time goals.

Responsibilities:

  • Have supply chain planning responsibility for Product Delivery-managed locations from NDP to finished goods to meet the demand plan supporting Lilly’s clinical trials.

  • Establish and maintain inventory management associated parameters for each material/plant in APO as well as authorizing NDP, bright stock and FING destructions.

  • Work closely with Clinical Trial Supply Managers to understand trial operating model and any constraints/issues with the demand forecast that have implications for the supply plan; plan bright stocking strategies, if applicable.

  • Reconcile pre-clinical and non-clinical demand forecasts in SAP; identify and communicate gaps in supply plan and decisions that need to be made.

  • Determine and execute planning heuristics in SAP/APO through CD&OP process; execute or schedule automated planning run; frequent review of alerts and plan adjustment.

  • Develop dating extension strategy; review primary pack and finished good batches eligible for dating extension at the time of stability time point approval; route extension request for approval in SAP; determine which plants will be restickered.

  • Optimize plan across the supply chain to ensure demand, shelf-life requirements and minimum dating requirements for FING planned orders can be met.

  • Understand how the supply plan developed impacts the global Business Unit budget, and develop plan in alignment with the budget, as necessary.

  • Create a supply plan with consideration for budget constraints.  Enable continuous supply of material to clinical sites while balancing costs and risks. 

  • Identify specific risks associated to the budget or risks to the study supply based on budget limitations.

  • Continually monitor and re-evaluate the supply plan during study progression and proactively communicate when changes in the supply plan impact the budget.

  • Provide information, as requested, for budget development and/or changes to an existing budget as they relate to creation of or changes to the supply plan.

  • Examples include but are not limited to number and timing of packaging and manufacturing runs.

  • Effectively lead and communicate with the cross-functional CT Material Operations team to deliver to plan, foster an environment of integrated teamwork and partnership, and influence without authority.

  • Collaborate with Plant Planners for capacity planning and scheduling at Collaboration Partners, adjust plan as needed for issues and changes.

  • Communicate clearly, concisely and effectively through all forms of communication.

  • Develop and oversee execution of contingency plans across functions when supply issues arise.

  • Plan NDP batch allocation to FING planned orders in accordance with material strategy.

  • Review and approve study specific Material Random Tables.

  • Identify and communicate packaging sample requirements.

  • Ensure alignment of Lilly and Commercial Partner addresses with regulatory documentation for packaging orders.

  • Be knowledgeable on how to apply GMPs/GCPs in a clinical trial environment. Review and follow procedures applicable to the clinical trial business to maintain compliance.

  • Be the primary CTSP&E point of contact to the CMC Team.

  • Proactively identify ways to improve day-to-day activities and practices.  Support and lead efforts to improve productivity, efficiency, product quality and/or risk reduction. Promote a culture of shared learning. 

Basic Requirements:

Bachelors degree, preferably in health care or sciences related field or 5+ years work experience in clinical trial research and/or supply chain.

  • At least 8+ years of supply chain or clinical trial research experience

  • Exceptional critical thinking, strategy development, and decision making skills

  • Ability to develop strategies and make decisions in the absence of an obvious answer/approach

  • Demonstrated problem-solving skills

  • Exceptional organization and time management skills

  • Strong partnership and communication skills – internal and external partners

  • Exceptional project management capabilities

  • Knowledge of investigational product requirements – GCP and GMP

  • Experience in SAP planning

  • Must speak fluent English

  • Additional Skills/Preferences:

  • APICS, Supply Chain Certificate (via MBA or specific university program)

  • Project Management Certification

  • Formal Project Management Experience

  • Inventory and supply management expertise

  • Clinical research/study expertise, including

  • How study or supply chain variability impact planning

  • How study supplies are determined and managed

  • How study blinding is maintainedAdditional Information:

  • Work outside of core hours may be required to support the portfolio across the globe

  • Minimal travel may be required, both domestic and international.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly 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.

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