Senior Scientist Analytical Development PDT

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Job Description

The Research and Development team for Plasma Derived Therapies (PDT) is dedicated to pioneering innovative therapeutic strategies for patients with rare and complex diseases. At Takeda, we acknowledge the substantial potential to more effectively meet the needs and expectations of both patients and healthcare providers through therapies derived from plasma, particularly for individuals facing immunologic, hematologic, and other intricate conditions.

The PDT Pharmaceutical Science & Devices team is agile and pioneering, dedicated to the development of cutting-edge plasma-derived drug products. Our Analytical Development Department (AD-PDT) is responsible for creating advanced methods for product characterization, aiding in process development, and managing the release of non-clinical and clinical materials. We conduct method development, release testing, and GxP stability studies both internally and externally in collaboration with qualified Contract Research Organizations (CROs).

As a pivotal role in evaluating and implementing new or enhanced analytical methods, the Senior Scientist is instrumental in advancing method development initiatives, particularly focusing on immunoglobulin and albumin projects. Furthermore, this position involves close collaboration with Pharmaceutical Science departments and Global Manufacturing Science to support root cause analysis projects aimed at resolving production challenges during process changes. The Senior Scientist ensures the selection of the most effective methodologies to precisely identify the root causes of discrepancies. Key responsibilities include:

• Scouting, Evaluating, and Implementing: Actively explore, assess, and implement innovative and cutting-edge analytical methods to boost the efficacy and efficiency of plasma-derived therapies.
• Driving Innovation and Mentorship: Lead initiatives in developing novel methodologies and technologies in the comprehensive evaluation of plasma-derived products. Additionally, serve as a mentor to less experienced team members, fostering their growth and development in innovative practices.
• Focus on Immunoglobulins and Albumin: Offer specialized expertise in the characterization and analysis of immunoglobulins and albumin, ensuring both product quality and compliance with industry standards.
• Collaboration: Engage effectively with cross-functional teams to strategically integrate new methods and technologies, fostering synergy and shared success within the organization. 
• Strategic Method Evaluation and Development (25%): Lead comprehensive evaluations of new technologies with a strategic focus on enhancing plasma-derived therapies, specifically immunoglobulins and albumin. Benchmark and pioneer analytical methods development that integrate cutting-edge technologies to drive efficiency and efficacy. You will steer decision-making processes and optimize analytical approaches with little to no supervision.
• In-Depth Feasibility Studies (25%): Independently conduct detailed feasibility studies in the laboratory, assessing the practicality, success rate, and real-world applicability of novel analytical methods and technologies. Develop extensive reports and documentation that inform decision-making processes and serve as a cornerstone for future projects.
• Advanced Scientific Support and Cross-Functional Collaboration (25%): Serve as a senior scientific advisor, providing autonomous support to Pharmaceutical Science departments and Global Manufacturing Science. Leverage your expertise in protein chemistry to discern and solve production issues during process changes, employing advanced methodologies for root cause analysis and resolution.
• Testing Strategy Supervision (15%): Exercise leadership in supervising testing strategies, ensuring they meet rigorous standards and comply with regulatory and internal quality protocols. You will guide team members in executing best practices while maintaining accuracy and reliability without oversight.
• Project and Budget Management (10%): Manage projects single-handedly, planning timelines and budgets for the introduction of innovative methods. Align these with organizational objectives, strategically allocating resources to maximize project deliverables, ensuring progress meets benchmarks and adapting plans as needed.

Education & Competencies

• At least 10+ years work experience in an analytical development role or a protein research function; experience within a plasma fractionation environment is a plus.
• Passion for Innovation: Enthusiasm for advancing plasma-derived therapies, with a strong drive to lead the development of innovative methods and contribute significantly to scientific progress.
• Analytical and Technological Expertise: Proficient in modern and advanced analytical technologies and techniques, with deep knowledge of test method development and GxP compliance. Understanding real-time analytical capabilities through at-line and online technologies is advantageous.
• Scientific and Problem-Solving Skills: Strong foundation in protein chemistry, enabling effective scientific support and collaboration in root cause analyses. Skilled in identifying, analyzing, and resolving complex issues efficiently.
• Leadership and Independence: Demonstrated ability to lead projects with minimal supervision, exercising autonomy and initiative while maintaining meticulous attention to detail to ensure accuracy and compliance with industry standards. Able to inspire and develop less experienced colleagues through guidance and support.
• Collaborative Communication and Documentation: Exceptional interpersonal communication skills for interacting with global teams and stakeholders. Proficient in preparing comprehensive reports and documentation that support analytical findings and inform decision-making.
• Reliability and Quality Management: High reliability and self-motivation, with an appreciation for quality standards. Competent in managing projects efficiently, including timelines and budget oversight, while adapting to dynamic challenges in a fast-paced environment
• Strategic Innovation and Flexibility: Ability to develop novel methodologies independently, with the flexibility to adapt and embrace new challenges, driving innovation within the department.

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