Senior Scientist, Analytical Sciences

Key Responsibilities:

• Serve as SME for RNA-based drug substance and drug product release and characterization assays including assay develop and optimize analytical methods as needed.
• Support analytical method validation, transfer, and troubleshooting to ensure compliance with cGMP standards.
• Collaborate with the Process Development teams to ensure seamless integration of analytical methods into DS and DP manufacturing workflows.
• Analyze, interpret, and present complex data to cross-functional teams and senior management.
• Author and review technical reports, protocols, SOPs, and sections of regulatory filings (IND, IMPD etc.).
• Assist in managing external analytical collaborations with CROs and CMOs, ensuring data quality and timelines are met.
• Stay current with emerging analytical technologies and apply innovative solutions to improve method robustness and efficiency.
• Support investigations and root cause analyses for any out-of-specification (OOS) results, deviations, or process failures.

Required Qualifications:

• PhD in Analytical Chemistry, Biochemistry, Molecular Biology, or related field with 2+ years’ experience; or MS with 7+ years or BS with 9+ years of relevant industry experience.
• 3+ years of hands-on experience in analytical method development for biologics, with experience in RNA therapeutics preferred.
• Expertise in chromatographic (e.g., UPLC -UV, and UPLC-MS) and spectroscopic techniques (e.g., UV-Vis), with a strong understanding of method validation requirements.
• Familiarity with cGMP and ICH guidelines for analytical development and quality control of small molecules and/or biologics.
• Experience with supporting design and management of stability studies, impurity profiling, and degradation pathways.
• Expertise with managing primary and working reference standard qualification, aliquoting, and long-term management across all end users of the material.
• Managed transfer, qualification, and ideally validation of methods. 
• Supported batch disposition, OOS, OOT, and investigations.
• Excellent written and verbal communication skills, with experience drafting technical reports and regulatory documents.
• Ability to work collaboratively in a fast-paced environment and manage multiple projects simultaneously.