Responsible for overseeing Ceva products manufactured at Contract (Development) Manufacturing Organizations (CMO, CDMO) including but not limited to: contract negotiations and management, project management of key activities outside of routine commercial supply, management of changes to existing products, performance improvement against metrics, and implementation of process improvements.

• Ensure CMOs operate against the requirements set in development and/or commercial supply agreements and periodically negotiate new elements of the supply agreements in conjunction with the Ceva Legal, Business Development, Industrial Development, or other departments, as appropriate.
• Support the on-going enhancement and optimization of manufacturing process systems by using a change management process.
• Manage the selection process for potential new CDMO/CMO, which will include building requests for information (RFI), request for quotation (RFQ), site evaluations, contract negotiations and presentations to senior management for final selection.
• Manage and support the industrialization implementation of new products at new or existing CDMO/CMO.
• Oversee CMO compliance to key metrics: Right First Time, Complaints/Defect Rate, On Time in Full, Shortages, Compliance and Relationship.
• Determine and manage business reviews with CMOs to review key metrics and drive improvements.
• Continuously develop and monitor plans for optimization of CMOs, which could include transfer of products for consolidation and/or discontinuation.
• Work with CMOs to determine process capabilities and bottlenecks, implement improvements, and develop contingency plans for capacity/productivity increases.
• Oversee the execution of capital projects associated with Ceva products at CMOs.
• Facilitate technical investigations into customer complaints and ensure corrective actions are put in place.
• Assist in obtaining and evaluating data and potential solutions for complex problems.
• Conduct business risk assessments and facilitate teams to conduct failure mode and effect analysis (FMEA) on manufacturing processes.
• Manage the launch of new products at CMOs in coordination with Marketing, Supply Chain, Quality, Regulatory and the Industrialization departments.
• Stay current on existing technology and vendors by attending key seminars and conferences (e.g., CPhI, Contract Pharma).

·Shape Solutions out of Complexity

·Client Focus

·Collaborate with Empathy

·Engage and Develop

·Drive Ambition and Accountability

·Influence Others

·Sourcing and Selection

·Contract Negotiation

·CDMO Market Acumen

·Vendor Management & Supplier Relationship Management

·Purchasing Process

·Cross Dimensional Risk Management

·Continuous Improvement of Performances

·Data Management:KPI Monitoring & Data Culture

·Project Management

Education -

·Bachelor's degree or equivalent years of experience

Work Experience -

·5 years of process, production, or project management experience in the pharmaceutical or applicable commercial manufacturing environment

·Knowledge of regulatory requirements - cGMP, CVM, EPA, OSHA, and FDA guidelines and how to apply them effectively is preferred

·Experience negotiating contracts/supply agreements

·Ability to read, write legibly and understand English

·Visual inspection

·Hybrid (on-site / in office and remote work).

·Travel requirement: 40-50% with some international travel requiring a passport

This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job. This job description is not intended to be an exhaustive list of qualifications, skills, duties, and responsibilities or working conditions associated with the job. This job description is not an employment contract. Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.

*VEVRAA Federal Contractor
**Ceva is an equal opportunity employer and all qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, age, genetic information, actual or perceived sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. Ceva encourages men and women, members of all racial and ethnic groups, individuals with disabilities and veterans to apply.

685C