Principal Scientist

Job Description: Principal Scientist About the Company: We're a leading biotechnology company dedicated to developing innovative biologics that transform patients' lives. Our cutting-edge research and development initiatives, combined with our commitment to quality, make us a trusted partner in the industry. Job Responsibilities: We're a leading biotechnology company dedicated to developing innovative biologics that transform patients' lives. Our cutting-edge research and development initiatives, combined with our commitment to quality, make us a trusted partner in the industry. Manage analytical methods from global vendors for biopharmaceutical drug substance and product manufacturing, covering various assays. Guide and oversee assay validation, transfer, optimization, and development strategies for commercial and clinical manufacturing. Collaborate with Quality and Manufacturing teams to analyze data for lot release, in-process testing, stability, characterization, and assay validation. Assist in preparing and reviewing CMC documentation for regulatory filings, including submissions to US and EU authorities. Experience Required: Proficiency in managing outsourced analytical tasks within the pharmaceutical development or commercial sector, including method development, validation, and transfer. Experaince of managing both development and GMP work in external analytical labs Able to support upstream and and downstream mfg. Able to communicate to Manufacturing/Process Development from an Analytical Development perspective technically. Extensive experience in analytical development and troubleshooting for biologics, covering a range of methodologies such as chromatography, immunoassays, residuals, and cell-based assays. Familiarity with vector and gene therapies is beneficial, but the candidate should demonstrate adaptability to new assay modalities based on their existing knowledge. Holds a PhD in chemistry, biochemistry, or a related field, with a minimum of 7 years of protein analytical experience in the pharmaceutical or biotech industry. Alternatively, a candidate with a BS/MS degree should possess an equivalent number of years of pertinent experience #J-18808-Ljbffr