Scientist I, QC Analytical

Description

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.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

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.