Senior Production Planner/ ERP

Role Summary

The Senior Production Planner is responsible for managing all production planning activities needed to meet early to late phase clinical and process development manufacturing requirements. The main objective of the Senior Production Planner is to coordinate and improve the production planning function through the implementation of planning best practices and active participation in the development of an ERP system.

Responsibilities

• Plan the production of finished good products with an ERP system to meet clinical and commercial demand of finished product.
• Create and maintain a master production plan in an ERP System and ensure that the right materials are available at the right time to support production schedules.
• Take follow up actions in relation to production shortages that affect distribution, or patient enrollment.
• Develop high-quality supply plans by utilizing best-practice processes.
• Understand and define default parameters for all products.
• Extrapolate data from multiple systems and summarize information in comprehensive report.
• Analyze data related to service level and inventory.
• Optimize reporting capabilities to monitor daily, weekly and monthly metrics.
• Complete root cause analysis and create suggestions on how to minimize future issues.
• Manage and support KPI performance metrics for inventory health, production order management, and manufacturing performance within an ERP system.
• Execute and monitor action plans and report progress against strategies to address issues/improve performance.
• Analyze finish goods inventories to improve production efficiency, increase inventory turns or reduce waste.
• Partner as part of a broad cross-functional team, play an integral role in implementation (data migration, UAT, Validation, go-live, etc.) of GxP modules in ERP (D365).
• Act as subject matter expert for ERP GxP operational modules for the production planning functions.
• Partner with users to develop use cases and testing scenarios for production planning tasks.
• Collaborate with D365 technical team to provide business process and configuration feedback on operational modules.
• Responsible for authoring and maintaining D365 operational SOPs for the production planning function.
• Ensure regulatory compliance to federal, state, and local agencies (FDA, CDPH, etc) by following established guidelines and providing corrective action plans are followed that will prevent legal exposure.
• Partner with Quality Assurance to maximize the return from Internal Assessments and QA Audits to provide objective evidence of adherence to cGMPs, FDA regulations, and Company procedures.
• Perform ad-hoc and cross-functional projects assigned to support business needs and provide developmental opportunities.

Qualifications

• Bachelor‚Äôs degree in engineering, business, or a related field required
• 5+ years‚Äô experience in planning operations in a pharmaceutical manufacturing/development environment required
• Experience implementing ERP systems required

Skills

• Knowledge of ERP systems like Microsoft AX, SAP, or JD Edwards
• Knowledge of Equipment: PC, scanners, voice mail and e-mail systems, and standard office machines, or ability to be trained
• Knowledge of ERP Systems, Windows and of other software
• Proficiency in MS Office applications, particularly Excel and PowerPoint
• Excellent oral and written communication skills
• Excellent attention to detail and organizational skills
• Ability to work within a team and independently as needed
• Excellent analytical and technical skills, including the ability to comprehend and integrate data from a variety of sources
• Ability to act in a manner consistent with company mission values, code of ethics policies, and other standards of conduct
• Ability to cooperate with other personnel to achieve department objectives and maintain good employee relations, interdepartmental objectives, and departmental goals and objectives

Education

• Bachelor‚Äôs degree in engineering, business, or a related field

Additional Requirements

• This position works onsite or remote based on the candidate‚Äôs geographic location.
• Lift and carry materials weighing up to 20 pounds.