Scientist 2 - Analytical Development
Overview
As a Scientist 2 in Analytical Development, you lead the development and validation of new analytical methods to broaden the service portfolio and meet market needs. You act as the SME for analytical method development/validation, ensuring methods are robust, standardized, and ready for implementation. You work across modalities such as mAbs, cell and gene therapies, ADCs, mRNA therapeutics, and viral vectors, driving improvements and guiding analysts and study managers. This role blends hands-on experimentation with strategic, cross-functional collaboration to advance regulatory-ready solutions.
Compensation / Benefitshealth insurancepaid time off (PTO)retirement contributionsother perquisites
ResponsibilitiesLead development and implementation of new analytical methods to expand laboratory capabilities and address gaps in current service offeringsDesign, optimize, and troubleshoot analytical assays to ensure fit-for-purpose and regulatory alignmentPerform hands-on execution and technical leadership across modalities including mAbs, cell and gene therapies, ADCs, mRNA, and viral vectorsKeep current on relevant literature and technologies and support their implementationIdentify improvement areas in current assays and propose solutionsAct as SME in analytical methods and provide guidance to analysts and study managersPrepare/review protocols, reports, SOPs, records, specifications, and related documentsExecute analytical methods for development/validation and transfer GMP assays to routine team with trainingOperate and maintain lab equipment per SOPs and testing proceduresUtilize computer programs during testing (Word, Excel, Oracle, LIMS, BRIQS)Lead change control and resolve deviations by completing event recordsContribute ideas to improve techniques, protocols, processes, and equipmentMaintain strong communication with internal and external stakeholdersPerform other duties as assigned
Key requirementsPh.D. in Analytical Chemistry, Chemistry, Biology, etc., with 3+ years of lab experience OR Master’s in same fields with 5+ years OR Bachelor’s with 7+ yearsExperience with analytical method development/validation in a pharmaceutical settingExcellent oral and written communication skills and ability to lead projectsStrong time management and ability to collaborate and work independentlyHigh initiative and leadership capabilities, with coaching/training skillsstrong communicationteam leadershipinitiativeLiquid Chromatography (HPLC; SEC, RP, IEX)Mass Spectrometry (Intact MW, Peptide Mapping, Disulfide Mapping, Glycan Profiling)Capillary Electrophoresis (CE-SDS, cIEF)