Job description
NovaBio Therapeutics is disrupting the field of precision biotechnology by developing next-generation therapeutics and diagnostic tools for complex diseases. We are seeking a Senior Analytical Scientist to lead the development and execution of analytical assays, ensuring robust data generation and regulatory readiness. In this role, you will collaborate with cross-functional teams, design and validate assays, interpret complex data, and contribute to the strategic roadmap for product characterization.
Responsibility
- Lead design, execution, and validation of analytical assays (e.g., HPLC, ELISA, qPCR, LC-MS) for product characterization and release testing.
- Develop and transfer analytical methods to QC/QA and ensure compliance with GMP, GLP, and regulatory guidelines.
- Analyze complex datasets using statistical tools; generate robust technical reports and data packages for regulatory submissions.
- Collaborate with R&D, Manufacturing, and QA to define specifications and acceptance criteria.
- Oversee method validation, stability studies, and cross-method comparisons.
- Troubleshoot assay performance and implement continuous improvement initiatives.
- Mentor junior scientists and contribute to SOP development and training.
Qualification
- PhD or Master's in Chemistry, Biochemistry, Biotechnology, or related field with 5+ years of analytical development within biotech/pharma.
- Strong knowledge of analytical methods (HPLC, LC-MS, GC, ELISA, qPCR), method validation, and regulatory standards (GLP/GMP).
- Experience with data analysis using Python, R, or JMP; proficiency in statistics.
- Ability to design and execute experiments, interpret data, and write technical reports for regulatory audiences.
- Experience with method transfer, tech transfer, and quality systems.
- Excellent collaboration, communication, and project management skills.
- Familiarity with regulatory submissions and quality documentation.