Generic Products Manager

Job Overview

The Generic Products Manager serves as the Product Manager for the Charles City proprietary/generics portfolio including those in the controlled substance category. This position is the primary liaison between commercial proprietary drug substance (DS) customers and internal teams.

Responsibilities

• Communicate effectively with internal teams, management, and sales to ensure appropriate visibility of existing status of product portfolio and potential risks affecting production and supply.
• Cook up with the Production Planner to maintain long-term schedules balancing customer needs inclusive of registered customer specifications (e.g. PSD and special testing), efficiency, and inventory to support On-Time In-Full (OTIF) delivery.
• Cook up with Scheduling and DEA functions to align client needs with production schedules and quotas.
• Monitor and resolve production issues, deviations, or delays to minimize customer impact.
• Work with Procurement on raw material forecasting and execution of orders needed to meet client demand.
• Support customer repack requests, including delivery and drying room scheduling.
• Lead or participate in investigations of deviations or rejects; prepare findings reports.
• Provide technical support and maintain strong customer relationships including direct customer interaction.
• Participate in and drive, when needed, customer complaint investigations to conclude in a timely manner.
• Serve as a resource for Sales, Senior Management, and Customer Service on allotments and customer feedback.
• Partner with the Director, Sales and Product Management on product allocations based on client needs and procurement quotas.
• Manage allocations for clients with special specifications (e.g., PSD).
• Collaborate with R&D, Process Engineering, Quality, and others to schedule mass balance sample testing and reporting.
• Organize and lead multi-disciplinary teams for customer-driven initiatives.
• Estimate and update product costs as needed.
• Ensure compliance with controlled substance manufacturing requirements; support Regulatory Affairs with inventory tracking and quotas.
• Assist with production management, including batch record reviews, investigations, and TrackWise approvals.
• Adhere to OSHA, EPA, DEA, FDA, and cGMP regulations and company safety procedures.
• Perform other duties as assigned to support departmental goals.

Qualifications/Skills

• General knowledge of chemical operations equipment and manufacturing processes.
• Strong team leadership and multi-disciplinary coordination skills.
• Understanding of business planning and financial impacts.
• Excellent project management skills with strong attention to detail.
• Proficiency with Windows-based computer applications.
• Understanding of SAP system functionality to ensure sufficient and proper information is captured to feed demand for procurement, production planning, and order fulfillment.

Education, Experience & Licensing Requirements

• Bachelor’s degree in Chemistry or Chemical Engineering; advanced degree preferred.
• Minimum of 5 years’ experience in the pharmaceutical industry.
• Experience in managing and leading cross-functional project teams.
• Familiarity with cGMP regulations and controlled substance requirements.
• Demonstrated experience in direct customer contact and relationship management.
• Must be willing and able to engage directly with customers as agreed with commercial sales.