Specialist, Analytical Technical Solutions (ATS)
$87,300–$137,400 year
On-site · Millsboro, Delaware, United States or De Soto, Kansas, United States
Job Summary
Specialist provides analytical support for the development, validation, and transfer of phase-appropriate analytical methods for large-molecule biotherapeutics. Performs and supports method development, validation, and transfer activities from R&D to QC, including HPLC-based method development for biologics characterization, interfacing with collaborators/CROs/CDMOs, and authoring/test procedures and reports. May serve as SME for deviations/OOS/OOT investigations, and will troubleshoot and maintain instruments (e.g., UPLC, LC-MS, particle counter, nanodrop). Based in Millsboro, DE or De Soto, KS, with duties executed in regulated/non-regulated environments and adherence to safety and quality standards.
Required Qualifications
- Bachelor’s degree in Life Sciences, Biology, Pharmaceutical Sciences or related fields with 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 (HPLC/UPLC/FPLC, SEC, LC-MS, SDS-PAGE, Western blot, UV-Vis, DLS, CE-SDS)
- Familiarity with regulatory guidelines (GMP, USDA, FDA, ICH) and data-processing software ( Empower, Chromeleon, OpenLab ChemStation or equivalent)
- Ability to multitask in a fast-paced environment and document experiments and results clearly
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