Analytical Technical Solutions Specialist

Responsibilities

• Develop, validate and transfer phase-appropriate analytical methods for characterization and release testing of Large Molecule drug substances and drug products
• Conduct HPLC based method development for characterization of biologics (may include, charge particle analysis, reduced mass etc.) to provide better understanding of biologics attributes
• Interface with collaborators, CROs and CDMOs to facilitate method development, validation and transfer activities
• Author, review and approve test procedures, protocols, and reports
• Plan, execute, document and data analysis and present results
• Troubleshoot and maintain lab instruments including but not limited to UPLC, LC-MS, particle counter, nanodrop etc. ensuring they remain in peak operational condition

• Bachelor’s degree in Life Sciences, Biology, Pharmaceutical Sciences or related fields
• 3+ years of experience in biotech or pharma industry
• Prior hands‑on experience in analytical method development for large molecules or proteins/monoclonal antibodies preferred
• Knowledge of method development and characterization of protein therapeutics using various analytical techniques, including liquid chromatography (HPLC/UPLC/FPLC, size exclusion chromatography, LC-MS), SDS‑PAGE, Western blot, UV‑Vis spectrophotometry, particle size by DLS or equivalent and capillary electrophoresis (CE‑SDS)
• ELISA, cell based, viral assays (TCID
  50, plaque assay, neutralization assays) and/or molecular biology experience are a plus
• Familiarity with regulatory (GMP, USDA, FDA, ICH) guidelines and industry best practices
• Ability to multitask and work in a fast‑paced environment
• Good attention to detail and ability to thoroughly document experiments, data, technical reports and findings electronically in an accessible manner with good documentation practices
• Familiarity with standard office software (MS Office, Teams, SharePoint, excel, PowerPoint etc.)