Associate Director – Molecule Planning

Job title:

Associate Director – Molecule Planning

Company:

Eli Lilly

Job description

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!Main Purpose and Objectives of Position:Clinical Supply & Delivery (CSD) function is accountable for partnering with drug development teams, clinical, CM&C, and the broader Clinical Supply and 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 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 Clinical Trial Supply Forecasting personnel, CMC Project managers, and Supply Planning Sr. Directors 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.Key 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 Associate Directors/Directors 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 the CD&OP process; execute or schedule automated planning run; frequent review of alerts and plan adjustment.
• Develop dating extension strategies; review primary pack and finished good batches eligible for dating extension at the time of stability time point approval; route extension requests for approval in SAP; determine which plants will be re-stickered.
• 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 Clinical Drug Supply (CDS) interface/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.
• Maintain ownership and emphasis on quality. Demonstrate engagement and employ a quality mindset in all endeavors by proactively identifying quality issues, perform change controls, lead investigations, and communicate appropriately.
• Lead or participate in special projects as needed for the business (process improvement/innovation projects, Master Scheduler activities, etc

Educational Requirements:Bachelors degree, preferably in health care or sciences related field or 8+ years work experience in clinical trial research and/or supply chain.Experience Requirements:

• At least 8 years of supply chain, drug development/CM&C, 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, influence, and communication skills – internal and external partners
• Exceptional project management capabilities
• Knowledge of investigational product requirements – GCP and GMP
• Experience in SAP planning or supply chain management

License/Certificate Requirements: NoneLanguage Requirements: Must speak fluent EnglishAdditional Preferences:

• APICS, Supply Chain certification
• 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 maintained
• Understanding of formulation development and drug stability

Additional Information/Requirements:

• Work outside of core hours may be required to support the portfolio across the globe.
• Minimal travel may be required, both domestic and international.

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 ( ) 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 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.#WeAreLilly

Expected salary

Location

Cork

Job date

Tue, 07 Jan 2025 23:24:15 GMT

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