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Generic Products Manager

Cambrex

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. It 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. Responsibilities Communicate effectively with internal teams, management, and sales to ensure visibility of the product portfolio status and potential production risks. Coordinate with the Production Planner to maintain long‑term schedules that balance registered customer specifications, efficiency, and inventory to support on‑time 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 interaction. Participate and drive, when needed, customer complaint investigations to conclude timely. 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. Qualifications and 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. Safety and Compliance All employees are required to adhere to OSHA, EPA, DEA, FDA, and cGMP regulations and 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. Pre‑Employment Screening and Disability Accommodation Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre‑employment screen, which may include drug testing, criminal record checks, identity verification, reference checks, education and employment verification, and other components as required by law. Refusal to submit to testing will result in disqualification of further consideration. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability or handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law. #J-18808-Ljbffr Cambrex

Vacancy posted 4 days ago
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