Research Associate 1, Process Development Contractor
ProKidney
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 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.
Job description
Responsibilities
- Execute experiments to optimize and improve processes for cell therapy manufacturing, including 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, 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.
Requirements
- 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 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 and critical thinking
- 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
- Eligible to work in the United States without the need for work visa or residency sponsorship
Company overview
ProKidney is a clinical-stage biotechnology company pioneering innovative cell-based therapies for the treatment of chronic kidney disease (CKD). The company's proprietary platform technology, known as Renal Autologous Cell Therapy (REACT), aims to regenerate damaged kidney tissue and restore renal function in patients with advanced CKD. ProKidney's lead product candidate, REACT, is designed to be a minimally invasive, autologous cell therapy that utilizes a patient's own renal cells to promote tissue repair and regeneration. The company's approach represents a paradigm shift in nephrology, moving beyond symptom management to potentially address the underlying causes of kidney disease progression. With a focus on late-stage CKD patients who face limited treatment options and the prospect of dialysis or transplantation, ProKidney's technology holds promise for improving patient outcomes and quality of life. The company has advanced its clinical development program through multiple clinical trials and has established itself as a leader in the field of renal regenerative medicine.