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Stability Manager
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$144,000 - $162,000 a year
Full-time
- Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked.
- Vaxcyte is looking for an energetic and talented individual to join Vaxcyte’s Vaccine Product Development organization as a Manager/Sr. Manager of Stability within Quality Control Unit. The primary function of this level position is to manage the stability program for various projects in preclinical and clinical development.
- Perform statistical analyses using statistical software’s such as JMP.This includes, but not limited to, creating, implementing, and managing stability databases, performing data trending and statistical analysis, forecasting and reporting of metrics, creation, revision and approval of SOP's, stability protocols and reports in accordance with current GMP, FDA, EU, Global and ICH guidelines and regulations.
- Manages Quality Systems records for QC Stability- creates, assesses, reviews Deviations, Change Controls, CAPA's and other applicable stability-related investigations and events.
- Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to stability study design, expiry dating, and analytical method qualification/validation for biologics and vaccines.
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