Responsibilities
● Collaborate closely with pharma science, regulatory, and quality control organizations, as well as process experts across our global plasma network.
● Provide leadership and guidance to team members, assisting them in prioritization, problem resolution, and process clarification.
● Direct the effective transfer of technology from design development to implementation.
● Evaluate the suitability of new technologies for implementation and transition to the manufacturing floor.
● Ensure successful product technical transfer to the new plasma facility.
● Establish reliable yield status and accurate yield forecasts for all transferred products, implementing strategies to meet yield targets.
● Develop and direct strategies for yield improvement projects, lead time reduction, process security, and deviation reduction.
● Assure process robustness and supply reliability by controlling the manufacturing process life cycle.
● Develop strategic plans that incorporate regional and global business practices and customer needs.
● Define and communicate strategic imperatives for project success, including market entry timing, innovative technology, and costs.
● Develop effective tech transfer project milestones, schedules, and manage budgets.
● Utilize state-of-the-art project management tools to ensure project schedules and budgets are met.
● Identify and resolve issues that may impact project schedules or improve project time.
● Understand and effectively communicate market niche and competitive forces influencing the project.
● Ensure team objectives align with key tech transfer projects for the new facility.
● Proactively prioritize and balance resource utilization for the project.
● Select, develop, and retain staff, providing constructive feedback, recognition, coaching, mentoring, and motivation.
● Generate innovative solutions to complex problems using multiple disciplines and technical principles.
● Create innovative products, processes, and methods through novel combinations of expertise within the organization.
● Perform other duties as assigned.
Qualifications
● Utilize your strong scientific background to contribute to the development and optimization of plasma manufacturing processes.
● Apply your knowledge of GMPs, FDA, EMA, PMDA, Lean, Six Sigma, and DMAIC methods to ensure compliance and continuous improvement.
● Demonstrate self-motivation, strong interpersonal skills, and the ability to analyze and solve complex problems through innovative thought and experience.
● Utilize project management tools to effectively manage multiple cross-functional teams simultaneously.
● Design and implement projects/studies outside your area of expertise, leveraging your scientific knowledge and skills.
● Provide strategic leadership and supervision to ensure the success of process development and tech transfer projects.
● Utilize your experience in change management to drive process improvement initiatives.
● Demonstrate a high level of customer orientation and organizational skills.
● Embrace a flexible and innovative mindset, thinking outside the box to drive continuous improvement.
● Communicate effectively, both verbally and in writing, to convey complex scientific concepts and project updates.
● Leverage your record of success in process development, tech transfer, project management, and regulatory submissions to drive the success of our plasma manufacturing processes.
● Collaborate with cross-functional teams in a highly matrixed, cross-functional, and geographically dispersed environment.
● Utilize your experience in GMP inspections to ensure compliance with regulatory requirements.
Education and/or experience
● Bachelor's degree in a science-related field required; Master's or PhD degree in a technical/scientific education, preferably biochemistry, biotechnology, or pharma, is preferred.
● Professional experience in a similar role in the field of Technical Operations, Process Management, or Manufacturing within the pharmaceutical industry, with significant experience in fractionation, purification, and fill-finish processes.
● Excellent verbal, written, and interpersonal communication skills in English and Japanese.
● Ability to build relationships, influence, and drive organizational engagement in a highly matrixed, cross-functional, and geographically dispersed environment.
● Strong knowledge and application of GMPs, FDA, EMA, PMDA, Lean, Six Sigma, and DMAIC methods.
● Proven experience in process development, tech transfer, project management, and regulatory submissions.
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