Company Information

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.

With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

• engage in work that matters to our customers and the patients they serve
• learn new skills and enjoy new experiences in an engaging and safe environment
• strengthen connections with coworkers and the community

We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!

Your Future Matters.

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!

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. 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.

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.

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.

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. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment 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/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.

#LI-RD1