Research Associate 2, Process Development

Position Summary:

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 biopharmaceutical development, process optimization, and technology transfer. In this role, you will lead or 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:

• Design and execution of 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 expertise in the development and implementation of new techniques and technologies. Support troubleshooting and process improvement initiatives.
• Work closely with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Manufacturing, to ensure the successful transfer of process into GMP clinical and commercial manufacturing.
• 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. 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 to identify potential risks in process development and manufacturing and implement strategies for mitigation, ensuring the successful advancement of cell therapy programs.

Qualifications:

• Bachelor's or Master's degree in Cell Biology, Biotechnology, Biochemical Engineering, or a related field.
• 2 plus years of experience in cell therapy and /or biopharmaceutical process development. Ability in execution and troubleshooting experiments, analyzing/ reporting/presenting data. Experience in aseptic techniques is essential.
• 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. Experience with regulatory submissions and support for inspections is a plus.
• Demonstrated troubleshooting and problem-solving skills.
• Understanding of basic statistics and working knowledge of statistical software (e.g. JMP).
• Must be comfortable handling human tissues.
• There will be occasional weekend work.