Job Description
• Manufacturing Schedule
• Develop weekly batching schedule by evaluating:
• Appropriate tanks required for each batch based on size and requirements
• Ancillary equipment required for each batch
• Availability of raw materials and/or prioritize based on ETAs
• Timing of micro testing and batch approval supports filling schedule
• Bulk orders complete by ship date communicated to customer
• Customer on-site visits and chemist availability for pilots
• Set daily batching schedule and assignment of batches by Compounder
• Set daily prioritization of Preweigh schedule
• Organization/Management
• Manage organization of ~20 people that runs across two shifts (1st shift runs 5am to 3:30pm and 2nd shift run 12pm to 10:30pm)
• Maintain vision for current and future-state organization staffing
• Maintain job descriptions and interview/hire for organization
• Complete monthly or quarterly reviews, depending on employee, of workplan and performance reviews with Compounders, Batching Assistants, Preweighers, and Manufacturing Supervisors
• Determine annual goals for all employees and provide ongoing performance feedback
• Provide direction and proper processes to Compounding and Preweigh teams to ensure proper quality standards are being followed
• Assign Training and Qualification required for each new employee and ensure completion within specified times
• Weekly reviews of temp agency time cards and bi-weekly reviews of employee time-cards
• Pilots, Scale-Up, and Customer Visits
• Lead Manufacturing Pilot Program for Compounding
• Weekly review with chemist to complete pre-pilot checklists for upcoming scale-ups
• Ensure completion of all pilot checklists
• Review results of all pilots with Chemists to determine if pilots were successful and/or if processing or specification updates are required
• Manage relationship with customers during scale-ups and ensure timely completion of any customer-requested follow-ups
• Participate in Stage Gate for early input to processing and equipment requirements for new formulations
• Perform root cause analysis with chemist if there is a scale up failure and determine appropriate corrective and preventative actions (CAPAs)
• Process and Engineering
• Develop control systems or work processes to minimize and resolve manufacturing issues including determining scope, cost, critical path schedule (CPS), and impact
• Develop and train employees on Work Processes to ensure all products meet quality control standards
• Partner with Director of Production to understand filling losses caused by Manufacturing; develop and implement countermeasures to reduce losses
• Determine when/where time-based maintenance (TPM) and inspection schedules should be implemented
• Submit Change Requests to quality and R&D to implement correction and improvement ideas
• Continuous Improvement
• Provide coaching, implement, and ensure compliance with 5S, Lean (Six Sigma), Standard Work, Training and Qualification documents, and cGMPs
• Perform root cause analysis on quality and equipment failures and implement CAPAs (Corrective Action, Preventative Action)
• Monthly review of batching procedure input from Compounders with chemists to drive continuous improvements and compliance of procedures
• Own Department Results
• Own department results and trend items such a reject/rework rate, number of batches complete in a week, total pounds made each week, weekly labor hours, etc.
• Responsible for department budget for non-capital equipment and supplies and expenses
• Raw Material Inventory
• Help develop and ensure compliance with raw material inventory management
• Set direction for weekly raw material cycle counts
• Root cause analysis of inventory inaccuracies
• Coaching on management of expired raw material work process
• Back-up to Compounding Supervisor
• Assign batches to Compounders, manage assignment of tank cleaning throughout shifts, complete batching paperwork, testing pH and viscosity on product when required
• Back-up to Preweigh
• Fill in for Preweigh during absences (must understand raw material weighing and inventory management system)

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