Sr Scientist, Analytical Sciences

Responsibilities

• Analytical Execution & Support
• Implement analytical strategies within the lab to ensure tight alignment with process development milestones and regulatory guidelines.
• Partner closely with Process Development to provide rapid, high-quality analytical testing for process optimization, routine characterization, and comparability studies.
• Contribute to the life cycle management of analytical control strategies by identifying, troubleshooting, and proposing assay updates or modern replacements.
• Provide the technical rigor and execute the characterization assays needed to support strategic, data-driven decisions for process comparability.

Assay Development & Innovation

• Lead from the bench in the design, development, qualification, and routine testing of novel analytical assays.
• Drive innovation in analytical platforms to improve assay sensitivity, throughput, and robustness, specifically tailored for complex cell therapies, including the implementation of bench-top automation.
• Develop new methods with a "right first time" mentality to ensure seamless, robust transition to a downstream GMP environment.

Tech Transfer & Technical Investigations

• Serve as the primary technical lead for the successful transfer of analytical methods from the internal development bench to external QC testing laboratories.
• Author method transfer protocols and oversee the technical execution of method validation at external sites, ensuring compliance with regulatory standards.
• Act as the technical subject matter expert (SME) to support troubleshooting, OOS/OOT investigations, and root-cause analyses with external CDMO/CRO partners.

Cross-Functional Leadership & Compliance

• Collaborate across the CMC team to author and review technical reports, SOPs, and analytical data packages supporting regulatory submissions (IND/BLA).
• Serve as a technical anchor in the laboratory, leading by example with high standards of strict scientific rigor and operational excellence.
• Manage personal laboratory resource allocation, instrument maintenance, and testing timelines to ensure seamless program delivery.