Scientist, Analytical Development

The Scientist in Analytical Development will play a critical role in the development and implementation of analytical methods to ensure the quality, safety, and efficacy of AAV-based gene therapies. The successful candidate will work collaboratively within both CMC and Translational functions by developing and validating assays for product development and regulatory submissions.

Key Responsibilities

Experimental Design and Execution:

Develop, optimize, and validate analytical methods across CMC and Translational projects including:

• Analytical methods for the characterization of AAV vectors, assays for potency, purity, identity, and safety.
• Bioanalytical assays such as ELISA, Jess, MSD, cell-based assays and other advanced techniques for protein and biomarker detection.
• Troubleshoot and improve existing methodologies to ensure scientific and operational excellence.

Data Analysis, conclusion and reporting:

• Design, execute, and analyze experimental studies, providing clear, concise conclusions to guide data-driven decision-making.
• Maintain accurate and detailed laboratory records in compliance with Good Laboratory Practices (GLP) and regulatory requirements.
• Author and review technical documents, including protocols, reports, and standard operating procedures (SOPs).

Collaboration and Project Support:

• Collaborate with Process Development, Quality Control, and Regulatory Affairs to support analytical method development, troubleshooting, and regulatory submissions.
• Perform routine testing and other studies to support the development and manufacturing of AAV gene therapies.
• Design and execute experiments to troubleshoot and improve existing analytical methods.

Continuous Learning:

• Stay informed with advancements in analytical technologies and apply new approaches to enhance assay development and performance.
• Participate in the transfer of analytical methods to internal and external partners, including contract research organizations (CROs) and contract manufacturing organizations (CMOs).
• Contribute to regulatory submissions by providing analytical data and supporting documentation.

Qualifications

• Master’s degree (M.S) in Biotechnology, Biochemistry, Molecular Biology, Analytical Chemistry, or a related field. PhD preferred but not mandatory.
• 2-5 years of industry experience in an analytical development role.
• Proven demonstrated expertise in bioassay development and hands-on experience with analytical techniques such as qPCR, dPCR, ELISA, Western Blot, flow cytometry, HPLC, and capillary electrophoresis, specifically for the characterization of viral vectors.
• Familiarity with statistical analysis tools and design of experiments (DOE).
• Experience in the validation of analytical methods in a GMP environment is highly desirable.
• Strong problem-solving capabilities, with the ability to troubleshoot complex technical challenges effectively.
• Exceptional attention to detail, ensuring accurate and thorough documentation in compliance with regulatory standards.
• Proficiency in authoring technical documents, presenting data to cross-functional teams, and preparing detailed reports.
• Ability to manage multiple projects, prioritize tasks, and deliver results in a fast-paced, dynamic environment.
• Fluent in Spanish and in English (both written and spoken).

Why joining Splice Bio?

At Splice Bio, you will be part of a dynamic team dedicated to making a meaningful impact in the lives of patients with rare diseases. We offer a collaborative and inclusive environment where innovation is encouraged, and your contributions will make a direct impact on the success and growth of the company. We also offer competitive compensation, comprehensive benefits, and opportunities for professional growth in an expanding field.