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 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 goods with an ERP system to meet clinical and commercial demand.
• Create and maintain a master production plan in an ERP system and ensure materials are available to support production schedules.
• Address production shortages affecting distribution or patient enrollment.
• Develop high-quality supply plans using best-practice processes.
• Define default parameters for all products.
• Extrapolate data from multiple systems and summarize information in comprehensive reports.
• Analyze data related to service level and inventory.
• Optimize reporting to monitor daily, weekly, and monthly metrics.
• Perform root cause analyses and propose actions to minimize future issues.
• Manage KPI performance metrics for inventory health, production order management, and manufacturing within an ERP system.
• Execute and monitor action plans and report progress against strategies to address issues and improve performance.
• Analyze finished goods inventories to improve production efficiency, increase inventory turns, or reduce waste.
• Collaborate as part of a cross-functional team in implementation (data migration, UAT, Validation, go-live, etc.) of GxP ERP modules (D365).
• Act as subject matter expert for ERP GxP operational modules for production planning.
• Develop use cases and testing scenarios for production planning tasks with users.
• Collaborate with D365 technical teams to provide business process and configuration feedback.
• Author and maintain D365 operational SOPs for production planning.
• Ensure regulatory compliance with federal, state, and local agencies by following guidelines and implementing corrective actions to prevent exposure.
• Partner with Quality Assurance to leverage internal assessments and audits to demonstrate adherence to cGMPs, FDA regulations, and company procedures.
• Perform ad-hoc and cross-functional projects to support business needs.

Qualifications

• Required: Bachelor’s degree in engineering, business, or a related field.
• Required: 5+ years of relevant progressive experience.
• Required: Experience implementing ERP systems.
• Preferred: Experience in a pharmaceutical manufacturing/development environment.

Skills

• Knowledge of ERP systems such as Microsoft AX, SAP, or JD Edwards.
• Familiarity with office equipment and software; proficient in MS Office, especially Excel and PowerPoint.
• Excellent oral and written communication skills; strong attention to detail and organizational abilities.
• Ability to work in a team and independently; strong analytical and technical skills; ability to integrate data from multiple sources.
• Commitment to company values, ethics, and conduct; ability to collaborate across departments to achieve objectives.

Education

• Bachelor’s degree in engineering, business, or a related field.

Additional Requirements

• Onsite or remote work depending on geographic location; regular Monday–Friday schedule with possible flexibility.
• Mobility to work in a standard office setting and to use standard office equipment; ability to lift and carry materials up to 20 pounds.