Analytical Development Scientist II

Serán BioScience provides custom formulation, process development and clinical manufacturing services for a variety of pharmaceutical clients. The Scientist II role will support the development, optimization, and validation of analytical methods used to characterize small molecule drug products for early and late phase clinical R&D to support client GMP Clinical Release and Stability programs. The work performed in this role will help to shape analytical strategy, collaboration across functions, and deliver high‑quality data that enables the success of early/late phase clinical programs.Duties And ResponsibilitiesPerform analytical testing such as UHPLC/HPLC, KF, Water Activity, Dissolution to support small molecules drug product development in GMP environmentDevelop and optimize methods for drug products across early phase and late phase clinical stagesExecute method transfers to QC or partner labs, ensuring robustness and compliancePlan, troubleshoot, and independently execute laboratory studies, generating high‑quality data for CMC decision‑makingPrepare and review technical reports, analytical methods, and protocols, contributing to regulatory‑ready documentationCollaborate with cross‑functional teams (QC, QA, Process Development, Project Management) and communicate results to internal and external stakeholdersAct as a subject matter expert (SME) in analytical development, providing technical leadership and supporting analytical strategyInitiate, draft, and perform testing for discrepancy reports; as necessaryMaintain GMP training certification to be able to perform work in a GMP laboratoryProvide regular updates to senior management on project progress Identify opportunities for process improvements and propose solutionsIdentifies out of trend dataResponsibilities may increase in scope to align with company initiatives. Required Skills/AbilitiesScientific curiosity and willingness to learnDemonstrates intermediate expertise with analytical equipment (e.g. disso, KF, GC, LC, XRPD, or mDSC; preferred LC and GC)Excellent verbal and written communication skillsExcellent organizational skills and attention to detailExcellent time management skills with a proven ability to meet deadlinesStrong analytical and problem-solving skillsAbility to prioritize tasks and to delegate them when appropriateAbility to function well in a high-paced work environmentDemonstrated ability to collaborate and work in cross-functional teamsAccepts feedback and constructively manages conflictProficient with EmpowerProficient with Microsoft Office Suite or related softwareEducation And ExperienceBachelor’s degree in chemistry or related field, with 4 years of hands-on lab experience preferred; or Master’s degree in chemistry or related field, with 2 years of hands-on lab experience preferredRequires 1 year of GMP experiencePhysical RequirementsProlonged periods of sitting or standing at a desk and working on a computerProlonged periods of standing or sitting while monitoring laboratory equipmentMust be able to lift up to 15 pounds at timesAdheres to consistent and predictable in-person attendanceWe may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.