Staff Analytical Scientist
Core
Develop, optimize, validate, and transfer analytical methods for iSRNA/siRNA oligonucleotides and peptide therapeutics to support manufacturing and quality control.
Role type
Staff Analytical Scientist (Technical Lead)
Builds
Robust, lifecycle-managed analytical methods for novel modalities
Domain
Biopharmaceuticals / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> production ML models (Incorrect mapping, correcting to: production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work is wrong, let's use the correct one from the list: dashboards & analysis is wrong. The role produces methods and data. The list options are: production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work. None fit perfectly, but 'research' or 'product features' (methods as features) or 'dashboards & analysis' (data). Let's look at the options again. 'research' fits the development aspect. 'product features' fits the method creation. Let's choose 'research' as it involves developing new assays and technologies.
Required skills
LC-MS/MS, CE, ion-pair RP-HPLC, peptide mapping, oligonucleotide characterization, method validation (ICH Q2), OOS/OOT investigation, DOE, statistical trending, technical writing, mentoring
Preferred skills
Experience with iSRNA/siRNA and peptide therapeutics, cross-functional collaboration
Technologies
LC-MS, CE, ion-pair RP-HPLC, hybridization-based assays, peptide mapping
Responsibilities
Establish and optimize analytical methods for product and raw materials; Design and review protocols for assay qualification and validation; Engage with vendors to implement new instrumentation; Transfer control test procedures to QC; Lead troubleshooting for process and formulation issues; Conduct investigations (OOS/OOT) and root-cause analysis; Train and mentor junior team members; Manage the lifecycle of analytical testing methods
Seniority
Staff, technical leadership & mentorship
