Prokidney is seeking to develop pioneering therapies to transform the treatment of CKD and change patients’ lives.
Requirements
- Experience in cell therapy and/or biopharmaceutical process development
- Ability in execution and troubleshooting experiments, analyzing/reporting/presenting data
- Experience in aseptic techniques
- Understanding of GMP, GLP, and regulatory requirements for the development of cell-based therapies
- Experience with regulatory submissions and support for inspections
- Understanding of basic statistics and working knowledge of statistical software (e.g. JMP)
- Experience with cell expansion and harvest, and product formulation
Responsibilities
- Design and execution of experiments to optimize and improve processes for cell therapy manufacturing
- Provide technical expertise in the development and implementation new techniques and technologies
- Support the characterization and validation of cell therapy processes, ensuring compliance with regulatory guidelines and internal standards
- Conduct process performance qualification (PPQ) studies and support clinical trial material production
- Ensure that all process development activities adhere to GMP and applicable regulatory standards
- Preparation and review of technical documentation, including process development reports, batch records, SOPs (Standard Operating Procedures), and change controls
- Assist to identify potential risks in process development and manufacturing and implement strategies for mitigation
Other
- Bachelor's or Master's degree in Cell Biology, Biotechnology, Biochemical Engineering, or a related field
- 2 plus years of experience
- Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects
- Strong problem-solving abilities, critical thinking, and the ability to collaborate with cross-functional teams
- Strong verbal and written communication skills, including technical writing
- Must be comfortable handling human tissues
- There will be occasional weekend work
