Scientist I, QC Analytical

The Scientist I, QC Analytical, is an experienced individual contributor responsible for independent execution, maintenance, and scientific oversight of GMP analytical methods supporting raw material, in-process, release, and stability testing. This role serves as an assay subject matter expert (SME) and key technical support for QC operations, method lifecycle activities, and investigations. The Scientist I provides scientific leadership within the laboratory, drives troubleshooting efforts, and ensures consistent compliance with GMP and data integrity requirements.

Requirements

• Perform Protein Characterization, Routine Testing or In-Process Support testing as required including: ELISA, SOS PAGE, IEF, HPLC, Western Blot, BCA, Capillary Electrophoresis, cell-based assays, spectrophotometric, spectrofluorometric and other pertinent biological and biochemical assays as they pertain to GLP and GMP standards in support of tech transfer and process development activities.
• Evaluate emerging techniques in protein characterization for the production of biotherapeutics and develop assay as required.
• Assist teammates in troubleshooting assay optimization difficulties.
• Direct day-to-day QCA-related laboratory activities and ensure that experimental plans are being followed.
• Be responsible for data review and data collaboration for assay projects.
• Work collaboratively and communicate data with department head as well as other involved parties.
• Actively support laboratory investigations, including: OOS, OOT, atypical result and Deviations related to analytical testing or documentation
• Create and/or Review of technical reports such as SOPs, experimental plans, interim project status reports and summary reports.
• Be prepared to optimize and troubleshoot new assays using sound scientific judgement with approval of department head.
• Assist in on-boarding and document creation for new instrumentation in the QCA Lab.
• Perform QCA Lab inventory checks. Create and manage Purchase Order requests for new projects.
• Record laboratory activities and results in appropriate notebooks.
• Assist Quality Control group in troubleshooting assays, where appropriate.
• Effectively interact and assist other groups within the Development groups (Cell Culture, Protein Purification, and Bio-Conjugation) and the Quality/Regulatory and Manufacturing groups on assay, and process related matters.
• Must be able to manage multiple projects.
• Demonstrate high attention to detail and proven track record of organizational excellence.
• Strong oral and written communication skills.
• Train on and become familiarized with all pertinent analytical techniques.

Education And Experience Required

• Bachelor's degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or a related scientific discipline required
• Master's degree in a scientific discipline preferred.
• Proven experience with analytical techniques including one or more of the following: HPLC/UPLC (SEC, RP, IEX, HIC), CE-based methods (CE-SDS, icIEF), ELISA or ligand-binding assays, UV/Vis, endotoxin (LAL/rFC), bioburden, pH, osmolality
• 5+ years of relevant experience in QC Analytical within a GMP-regulated biotech or pharmaceutical environment.
• Hands-on experience with biologics analytical methods.
• Prior participation in regulatory inspections and internal audits.