Senior Scientist Ii

Overview

• Lead analytical method development for large molecule drug formulations, ensuring quality and compliance from early clinical stages to commercialization.
• Collaborate with cross-functional teams and external partners to meet project goals and timelines effectively.
• Provide technical expertise in assay development, validation, and troubleshooting for drug characterization and stability studies.
• Contribute to regulatory submissions by preparing high-quality experimental protocols and technical reports.
• Maintain knowledge of cutting-edge assay technologies and implement innovative techniques to enhance analytical processes.
• Support Quality Control with robust method development, validation, and transfer activities.
• Train and guide team scientists, fostering a collaborative and productive work environment.
• Represent as analytical lead on CMC project teams, providing scientific solutions and strategic input.

Key Responsibilities & Duties

• Develop, validate, and transfer analytical methods for large molecule drug formulations and potency assays.
• Conduct stability studies, perform trend analysis, and interpret data to support decision-making.
• Collaborate with external CROs and CMOs to ensure project quality and timeliness.
• Troubleshoot technical challenges independently and generate high-quality scientific data.
• Prepare experimental protocols and technical reports for regulatory submissions.
• Provide training and guidance to team members, enhancing their technical expertise.
• Participate in departmental meetings, offering scientific and regulatory advice.
• Support QC with method validation, product specifications, and method transfers.

Job Requirements

• Ph.D. in biochemistry, immunoanalytical/analytical chemistry, or related field with 8+ years of experience.
• Extensive knowledge of chromatographic techniques, HPLC, LC-MS, ELISA, and other bioassay methods.
• Proven ability to develop, validate, and transfer analytical methods for large molecules.
• Experience in stability studies, trend analysis, and regulatory submissions.
• Strong leadership skills and ability to collaborate effectively with cross-functional teams.
• Knowledge of GxP, ICH, FDA regulations, and compliance standards.
• Excellent written and verbal communication skills for presenting data and preparing reports.
• Hands-on experience in laboratory experiments and instrument operation.