Exciting Opportunity: CDMO Specialist

Are you ready to excel in a pivotal and challenging role within the pharmaceutical industry? Our client, a global leader dedicated to transforming healthcare and saving lives, is seeking a highly motivated and skilled CDMO Specialist to join their dynamic team in the bustling city of Tokyo, Japan. This permanent position offers a remarkable opportunity for a dedicated professional who is eager to play a key role in driving innovation, ensuring operational excellence, and supporting the seamless delivery of life-saving medicines to patients worldwide. If you are looking to make a difference in a highly impactful sector, this role is your gateway to a fulfilling career.

Your Role

Key Responsibilities and Skills You'll Bring

• Project Management & Technology Transfer: As a CDMO Specialist, you will lead the launch of New Product Introductions (NPI) and oversee seamless technology transfers. This includes coordinating cross-functional teams, ensuring adherence to strict timelines, managing budgets effectively, mitigating risks, and fostering a culture of continuous improvement. Your ability to streamline processes and align diverse stakeholders will be critical to the success of these projects.


• Manufacturing Operations: You will be responsible for ensuring efficient and accurate management of critical manufacturing elements, including budgets, contracts, and agreements. Additionally, you will play a pivotal role in addressing deviations, implementing corrective and preventive actions (CAPA), and managing change controls. Your focus on process optimization will contribute significantly to operational excellence and cost-effectiveness.


• Site Performance Monitoring: A core aspect of your role will involve tracking and analyzing key performance metrics to assess the effectiveness of operational activities. You will work to standardize tools and processes, facilitate productive meetings with stakeholders, and utilize data-driven insights to identify opportunities for improvement and innovation. Your efforts will directly contribute to enhancing site performance and achieving strategic goals.


• Regulatory Expertise: With extensive familiarity in current Good Manufacturing Practices (cGMP), FDA regulations, and pharmaceutical validation processes, you will ensure compliance with stringent industry standards. Your regulatory knowledge will be pivotal in maintaining the integrity and quality of manufacturing operations, safeguarding patient safety, and meeting global regulatory requirements.


• Cross-Functional Leadership: This role requires exceptional matrix management and negotiation skills. You will work closely with diverse teams, leveraging your leadership abilities to drive collaboration, resolve challenges, and align objectives. Your ability to build strong relationships and foster teamwork will be fundamental to achieving project success and organizational goals.


• Technical Proficiency: Your deep understanding of pharmaceutical manufacturing processes and operational excellence will be complemented by your technical expertise. Proficiency in tools such as Microsoft Project, Excel, PowerPoint, Visio, and Smartsheet will enable you to manage projects effectively, communicate insights, and deliver impactful results.


• Problem-Solving: In this dynamic role, you will tackle complex challenges with critical thinking and strategic decision-making. Your strong business acumen, combined with your ability to analyze situations and implement practical solutions, will drive positive outcomes and contribute to the long-term success of the organization.

Location

This exciting opportunity is based in Tokyo, Japan, a city renowned for its blend of traditional culture and cutting-edge innovation.