Principal Scientist, Analytical Sciences

• Serve as SME for synthetic oligonucleotide-based drug substance and drug product release and characterization assays. Develop and optimize analytical methods as needed.
• Support analytical method validation, transfer, and troubleshooting to ensure compliance with cGMP standards.
• Collaborate with the Process/Formulation 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.

• PhD in Analytical, Organic Chemistry, or related field with 3+ years’ experience; or MS with 7+ years or BS with 10+ years of relevant industry experience.
• 3+ years of hands-on experience in analytical method development for small molecule therapeutics. Experience in synthetic oligonucleotide therapeutics is desired.
• Expertise in chromatographic (e.g., LC -UV, and LC-MS) and spectroscopic techniques (e.g., UV-Vis), with a strong understanding of method validation requirements.
• Experience with compendial methods used to release sterile products and compendial method verification.
• Familiarity with HRMS analysis in the identification of DS impurities.
• Functioning knowledge of the chemical principles of molecular degradation pathways.
• Strong understanding of cGMP and ICH guidelines for analytical aspects of small molecule sterile products in clinical development.
• Experience with supporting design and management of stability studies
• 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.

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