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Job Description
Position Overview:
Takeda is seeking a highly skilled and self-motivated Senior Scientist to join our Analytical Development Biologics team. The position is central to advancing our biologics pipeline by driving the development of high-quality analytical methods, supporting innovative solutions, and collaborating across functions to meet strategic goals. Expertise in analytical methods and bioassay development is key to ensuring the success of this role in supporting Takeda’s biologics portfolio.
Key Responsibilities:
1. Analytical Method Development & Optimization:
- Develop and optimize bioassays, including but not limited to:
- Immunological assays (e.g. ELISAs) to recapitulate the Mechanism of Action (MoA), residual impurity assays, and surrogate potency assays.
- Design experiments to achieve robust bioassays aligned with project needs and Analytical Quality by Design (AQbD) principles (ICH Q14, ICH Q2(R2), etc), and global regulatory expectations for biologics.
- Expertise in label-free technologies, such as Octet (Biolayer Interferometry - BLI) or SPR (Surface Plasmon Resonance), to support method development and characterization of biopharmaceuticals is preferred.
- Troubleshoot and resolve technical challenges associated with bioassay development, ensuring bioassays are robust and transferable to Quality Control laboratories (internal and external).
- Leverage advanced statistics-based strategies to optimize bioassays and accelerate method development timelines, (e.g. Design of Experiments (DoE)).
- Focus on automation opportunities, including developing automated bioassays, with a goal of in-silico implementation and advanced analytics.
2. Cross-Functional Collaboration:
- Represent Analytical Development in CMC sub-teams, ensuring the alignment of method development activities with program milestones.
- Provide scientific and technical input to troubleshoot challenges across biologics programs.
- Serve as a key analytical resource, facilitating collaboration and communication across internal teams and external partners.
3. Technology Transfer & Documentation:
- Lead the transfer of analytical methods internally and to external vendors, ensuring seamless transitions with high-quality standards.
- Prepare and review experimental protocols, method transfer documents, technical study reports, and relevant documentation to align with regulatory and organizational requirements.
- Resolve technical issues proactively during and after the transfer process in collaboration with cross-functional stakeholders.
4. Leadership & Mentorship:
- Mentor and train junior team members in assay development and execution techniques, focusing on hands-on expertise in bioassay development.
- Act as a Subject Matter Expert (SME) for specific analytical methods, providing leadership and guidance within project teams.
- Contribute to creating a collaborative and innovative work environment, driving a culture of continuous learning and improvement.
5. Innovation & Continuous Improvement:
- Research and adopt emerging technologies and methodologies to strengthen bioassay development capabilities.
- Propose and lead initiatives for automating analytical workflows, aiming for higher efficiency and quality through innovation.
- Stay updated on advancements in analytical sciences and regulatory expectations, contributing to the development of forward-thinking strategies.
6. Data Management & Reporting:
- Design, execute, and analyze experiments; generate and interpret data for biologics characterization and quality control.
- Ensure analytical development work is documented in electronic laboratory notebooks according to good documentation practices.
- Compile results into comprehensive technical reports, communicating findings to internal teams and stakeholders.
Education and Experience Requirements (preferred):
- Bachelors degree and 11+ years relevant industry experience
- Masters and 9+ years relevant industry experience
- PhD and 3+ years relevant industry experience
Critical Expertise Required:
- Proficiency in developing and optimizing bioassays (e.g. ELISAs, including MoA mimic assays, residual impurity ELISAs, and potency assays).
- Deep understanding of bioassay development principles, automatable assay platforms, and advanced experimental designs (DoE).
- Solid understanding of CMC processes.
The successful candidate will play a critical role in advancing Takeda’s biologics pipeline by delivering innovative and robust analytical solutions.
