Senior Scientist - Analytical Development Biologics

Senior Scientist - Analytical Development Biologics

Erstellt mit künstlicher Intelligenz

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Job Description

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.

1. 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.

1. 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.

1. 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.

1. 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.

1. 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.

LocationsAUT - Wien - Benatzkygasse 2-6

Worker TypeEmployee

Worker Sub-TypeRegular

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