Job Reference: JO-2101-65531_1610385533
An amazing career opportunity has arisen for a dynamic NPI Program Manager to provide technical support and program management to our clients new manufacturing operation and NPI's.
The successful candidate will be a key contact within the global organisation for all pipeline products. Collaborating with R&D and Global Program Managers, you will develop and execute strategies for clinical and commercial supply of new products. You will also lead cross-functional teams, including manufacturing, engineering, technical operations, quality assurance, purchasing, and supply chain to execute the strategies for developing and supplying new products.
- Provide Technical support to all manufacturing operations and to reduce standard product costs by the successful identification and implementation of continuous improvement initiatives
- Develop realistic cross-functional program implementation plans with input from R&D, Engineering, Manufacturing, Quality, Regulatory, and Commercial
- Coordinate global project teams to perform technical transfers of products and global launches of new device programs
- Assist cross-functional teams in the execution of strategies for the supply of development and clinical supply of new products
- Maintain program budgets
- Set project milestones and report progress accordingly. Consider alternative approaches and take corrective action as needed to ensure project milestones are achieved
- Supports supplier selection, technology transfers, capital expansions, regulatory filings, and building of launch supplies
- Adheres to and supports all EHS & E standards, procedures and policies
- Operates in an environment which is largely self-managed but with supervision through the Supply Chain and Business Systems Manager
- Degree in Engineering, Science, Business, Project Management, or a related discipline with advanced degree preferred.
- PMI certification is highly desirable
- 5+ years of diversified Biologics/Pharma/Medical Device business experience, including operations support/quality at the plant level, supply chain, validations, capital and expense management, and commercial product launches
- Experience in leading international cross-functional teams
- Experience in influencing peers in other organizations and senior management
- Results-driven contributing to the achievement of the businesses financial and strategic goals
- Expert knowledge of procedures, policies, and guidelines for compliance with cGMP and HPRA/FDA regulations
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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