POSITION OBJECTIVE: The Supply Chain Planner will be responsible for developing integrated plans to ensure sufficient supply of clinical materials for clinical trials. The planner will work with the Manager of Clinical Supply to develop the demand plans for each clinical program and use these plans to work with Clinical Manufacturing to create manufacturing timelines and planned schedules. The planner will be responsible for inventory management of APIs, bulk drug supplies and finished clinical supplies; and supply chain processes in the QAD ERP system.
Essential Job Functions/Responsibilities
- Develops integrated plans to ensure sufficient supply of clinical materials for clinical trials. Supports clinical material supply and materials management operational tasks related to clinical trials.
- Develop demand plans for each clinical program.
- Responsible for turning the consolidated forecast of final pack items into a primary pack plan, bulk drug plan and API supply plan which includes lead time offsets and yields.
- Responsible for maintaining targeted inventory levels of final, primary, bulk and API.
- In collaboration with the Manager of Clinical Supply responsible for setting inventory policies for inventory levels of final, primary, bulk and API.
- Enters clinical supply information in QAD including item number, lot number, material location, quantity and expiration date. Accountable for direct input of accurate, timely and consistent information into QAD.
- Review inventory reports from CMOs. Record inventory balance changes accurately in QAD to reflect the physical flow of material, ensuring lot traceability.
- Complete entries in QAD including creating/maintaining purchase orders, creating/maintaining work orders, product structures, inventory transactions, stock transfers, inventory adjustments and disposals.
- Investigate and resolve inventory discrepancies in a timely manner. Work closely with CMO contact for detailed inventory movements and changes.
- Develop procedures and workflow for clinical supply planning and inventory management. Review and revise SOPs to streamline and to improve current practices.
- Prepare planning information for each clinical program to support yearly budget preparation and quarterly review updates.
- Accountable for ensuring supply chain excellence and continual focus on cost savings, risk reduction and improving customer service.
- Responsible for facilitating the cross-functional demand and operations planning meetings for clinical programs. Must manage regular meeting schedules, agendas, meeting minutes and follow through. Develop and maintain strong working relationships with others at all appropriate levels of the organization.
- Manage the clinical order process for clinical trial materials and R&D material requests. Ensure order process is developed to accommodate materials requested from all CMOs and third-party logistic providers. Streamline process for efficiency, visibility and communication.
- Effectively achieve work through others that do not report directly to them.
- Demonstrates thorough understanding of planning and inventory management. Complete understanding of master data elements including yields, lot sizes, lead times, constraints, order multiples, ABC categories, etc.
- In depth knowledge of pharmaceutical supply chains used in commercial and clinical supply.
- Proficient in Excel with ability to develop and manage complex workbooks.
Required Education & Qualifications
· Bachelor’s degree in business or supply chain discipline or equivalent experience.
· Five years of inventory management and planning experience – FDA regulated environment a plus
· Strong oral and written communication skills, and interpersonal skills
· Excellent planning skills with the ability to work seamlessly as part of a team or independently.
· Highly detail oriented and organized in work.
· Ability to meet deadlines.
· Strong inventory process background with proven track record of accuracy and compliance.
· Strong ability to collaborate and build strategic relationships with internal (clinical operations, quality, etc.) as well as external (CMO, CRO, Storage sites, etc.) stakeholders.
· Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
· Knowledge of cGMPs and relevant FDA and EU Regulations
· Demonstrated ability of working in a developing environment balanced with an ability to establish plans and drive results
· Problem solving abilities suitable for handling complex issues associated with global supply
· Demonstrated ability and flexibility to work with aggressive and changing timelines, with limited information and without defined absolutes.
· Comprehensive knowledge of Microsoft Word and Excel.
· Knowledge of and experience with ERP and MRP systems required.
Preferred (Not Required) Qualifications:
· APICS certification a plus
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.