Scientist, Analytical Development

About the role

We are seeking a talented and highly motivated Scientist, Analytical Development to support analytical strategy and method development for complex therapeutic programs, with an emphasis on biologics and cell and gene therapy.

Responsibilities

• Develop, optimize, qualify, and support transfer of analytical methods for characterization of therapeutic materials, intermediates, and final products
• Apply and troubleshoot analytical techniques including HPLC/UPLC, LC-MS, DLS, SEC-MALS, and CE
• Perform biophysical characterization to assess critical quality attributes such as purity, aggregation, size distribution, molecular weight, and heterogeneity
• Generate, analyze, interpret, and clearly communicate analytical data to cross-functional teams
• Author and review technical documents including protocols, reports, method qualification summaries, and development reports
• Support product and process development through analytical testing for comparability, formulation, stability, and process-related investigations
• Collaborate closely with partners in process development, manufacturing, quality, regulatory, and research functions
• Support collaboration activities with external contract organizations as needed
• Maintain accurate and complete documentation in accordance with applicable quality and compliance standards

Requirements

• Bachelor’s, Master’s, or PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Molecular Biology, or a related scientific discipline
• Relevant industry experience in analytical development, pharmaceutical development, biotechnology, or a related field
• Strong hands-on experience with HPLC/UPLC and LC-MS, including method development, optimization, and troubleshooting
• Prior experience with biophysical characterization techniques, including DLS, SEC-MALS, and CE, is beneficial but not required
• Demonstrated ability to interpret complex analytical data and draw scientifically sound conclusions
• Strong written and verbal communication skills, with the ability to present findings clearly to technical and cross-functional audiences
• Strong organizational skills and ability to manage multiple priorities in a dynamic environment

Qualifications

• Experience supporting cell and gene therapy programs, biologics, or other advanced therapeutic modalities
• General knowledge of analytical considerations for complex biologics or cell and gene therapies
• Experience with analytical method qualification, comparability studies, stability studies, and technology transfer
• Familiarity with work in regulated environments, including GLP/GMP practices
• Proven ability to work collaboratively across multidisciplinary teams