Generic Products Manager

Cambrex•Charles City, IA

18d

About The Position

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. This position works closely with customers, Sales, Production, Quality Assurance, Quality Control, and Regulatory Affairs to ensure customer needs are met while maintaining compliance with regulatory requirements and supporting efficient product manufacturing.

Requirements

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.
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.

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.
Coordinate 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 OTIF delivery.
Coordinate 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.
Work with Scheduling to monitor controlled substance sample inventory for generics.
Partner with Process Engineering on process improvements and batch record revisions.
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.
All employees are required to adhere to OSHA, EPA, DEA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.