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