ASAT Scientist
| Company | ProKidney |
|---|---|
| Location | Winston-Salem, NC, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | |
| Experience Level | Senior, Expert or higher |
Requirements
- Excellent technical writing skills are essential
- Hands-on experience with flow cytometry and In-depth knowledge of molecular and/or cell biology is required
- Knowledge of relevant ICH and regulatory guidelines and good understanding of GMP concept
- Experience with analytical support for late-stage or commercial biological products and cGMP manufacturing
- Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency
- Partners effectively with internal and external functions
Responsibilities
- Work independently or in collaboration with internal and/or external partners in analytical lifecycle activities including method development, validation, and method transfer
- Author and/or review technical documents, including method SOP, study protocol and technical report
- Be a key Subject Matter Expertise (SME) and represent ASAT to participate in troubleshooting and OOS investigation occurred during release and/or stability testing
- Provide SME assessment for deviation, CAPA and change control
- Perform analytical testing, specifically flow cytometry, in support of product and process characterization for clinical product
- Perform data trending analysis
- Participate in internal and external meeting
Preferred Qualifications
- Experience in Gene and Cell therapy is desirable
- Experience with NGS technology is a desirable
- Experience of using JMP or similar statistical tools is a plus