The Scientist III role involves advanced scientific and technical responsibilities focused on protein characterization, assay development, and biophysical analysis. This includes performing detailed physicochemical, functional, and biophysical property analyses, immunogenicity assessments, and impurity profiling using techniques such as ELISA, SDS-PAGE, IEF, HPLC, and capillary electrophoresis. The position requires optimizing and troubleshooting complex assays, drafting technical documentation like method qualification protocols and reports compliant with FDA, GMP, and ICH guidelines, and maintaining laboratory equipment. As a Subject Matter Expert, the Scientist III collaborates with the Sr. Manager of QC-A for assay development, mentors junior scientists, and works with cross-functional teams to ensure alignment with project goals. The role also involves evaluating and integrating emerging technologies, managing multiple projects, and driving innovation and process optimization to support scientific and operational excellence.

Responsibilities:

• Conduct physicochemical, functional, and biophysical property analyses, including cell-based assay assessments and impurity profiling, to ensure robust protein characterization.
• Demonstrate proficiency in ELISA, SDS-PAGE, IEF, HPLC, Western Blot, BCA, capillary electrophoresis, and spectroscopic methods for accurate and reproducible results.
• Evaluate thermal stability, aggregation propensity, degradation pathways, and hydrophobicity using advanced chromatography methods such as Hydrophobic Interaction Chromatography (HIC) and Reversed-Phase Chromatography (RPC).
• Utilize techniques like Ion Exchange Chromatography (IEC), Size Exclusion Chromatography (SEC), and Isoelectric Focusing (IEF) for in-depth charge and size variant characterization.
• Design, optimize, and troubleshoot complex analytical assays with a high degree of scientific rigor to ensure accuracy and reliability.
• Perform quantitative analysis of impurities, including Host Cell Proteins (HCPs), using ELISA and mass spectrometry to meet stringent quality standards.
• Serve as an SME in binding assays and complex characterizations, such as dual binding verification and heterogeneity analysis.
• Design and execute potency assays to evaluate biological activity, including advanced cell-based studies.
• Maintain strict adherence to FDA, GMP, and ICH guidelines across all testing, documentation, and data reporting processes.
• Draft, review, and maintain high-quality documentation, including SOPs, experimental protocols, technical reports, and project summaries, ensuring clarity and compliance.
• Oversee routine maintenance, calibration, and onboarding of laboratory equipment to ensure operational readiness and compliance with regulatory standards.
• Partner with analytical, quality assurance, and manufacturing teams to align assay development and process optimization activities with organizational goals.
• Guide and train junior scientists and analysts in assay techniques, troubleshooting, and data interpretation, fostering professional development and scientific excellence.
• Evaluate and implement emerging technologies to enhance laboratory workflows and analytical capabilities, driving continuous improvement.
• Manage multiple projects simultaneously, ensuring timely execution, reproducible data generation, and achievement of key milestones.

Experience/Qualification:

• Bachelor’s or master’s degree in Biochemistry, Molecular and Cellular Biology, Immunology, Chemistry, Bioengineering, or a related field.
• 7+ years of hands-on experience in analytical method development, qualification, validation, and troubleshooting within pharmaceutical or biotechnology environments, specializing in techniques such as ELISA, CE-SDS, SEC-HPLC, cell-based assays, and impurity testing.
• Extensive expertise in technical writing, with a proven ability to draft clear, regulatory-compliant protocols, SOPs, reports, specifications, and investigation plans, ensuring alignment with cGMP, ICH, USP, and WHO guidelines.
• In-depth knowledge of biochemistry, molecular and cellular biology, and biological pathways, enabling comprehensive understanding and effective implementation of analytical methods for biotherapeutics, including assay optimization and qualification.
• Strong skills in equipment maintenance and troubleshooting, with hands-on experience in maintaining, calibrating, and troubleshooting laboratory instruments to ensure operational readiness and compliance with regulatory standards.
• Proven ability to manage multiple complex projects, collaborating cross-functionally, mentoring junior scientists, and ensuring the successful execution of analytical methodologies that meet performance standards and regulatory requirements.