ProKidney is seeking an experienced research associate for our cell therapy process development team. The ideal candidate will have a strong background in cell therapy or upstream biopharmaceutical development, including process characterization and optimization. In this role, you will support the development and improvement of cell therapy manufacturing processes, contributing to the advancement of cutting-edge therapies. This is a great opportunity for individuals who are passionate about making an impact in the evolving field of cell therapy.

Responsibilities:

• Execute experiments to optimize and improve processes for cell therapy manufacturing, including but not limited to media preparation, cell expansion and harvest, and product formulation. Analyze experimental data and present results in a clear and actionable manner to stakeholders.
• Provide technical feedback as part of development and implementation of new techniques and technologies. Support troubleshooting and process improvement initiatives.
• Work closely with cross-functional teams, including manufacturing science and technology, analytical development, quality control, and quality assurance to ensure study findings are accurately summarized and reported in a timely manner.
• Support the characterization of cell therapy processes, ensuring compliance with regulatory guidelines and internal standards.
• Ensure that all process development activities adhere to GMP and applicable regulatory standards. Support regulatory filings and audits as needed.
• Preparation and review of technical documentation, including process development reports, batch records, SOPs (Standard Operating Procedures), and change controls.
• Assist in identification of potential risks in process development and manufacturing and help implement strategies for mitigation, ensuring the successful advancement of cell therapy programs.

Qualifications:

• Bachelor’s or master’s degree in chemical engineering, biomedical engineering, biochemistry, cell biology, biotechnology, or a similar field.
• 2 plus years of experience in cell therapy and /or biopharmaceutical upstream process development. Ability to execute cell culture processes in typical lab settings, from vial thaw through cell expansion and harvest. Experience in aseptic techniques is required.
• 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.
• Understanding of GMP, GLP, and regulatory requirements for the development of cell-based therapies.
• Must be comfortable handling human tissues and primary human cells.
• Occasional weekend/off shift work may be required as part of this role.