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SalaryJob 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.
