Research Associate I, Process Development

Job Summary

The Research Associate I, Cell Process Development supports the development, optimization, troubleshooting, transfer, and validation of cell therapy manufacturing processes. This position performs laboratory-based activities, executes study protocols, analyzes data, and documents results under the guidance of more senior team members while contributing to process improvement and technical support activities.

Responsibilities

• Assist with studies to optimize and/or validate new or improved cell processing methods.
• Perform laboratory experiments and execute study protocols according to approved procedures.
• Support technical investigations related to manufacturing process deviations and failures.
• Absorb and document investigations in technical reports, memoranda, and other controlled documents.
• Support troubleshooting activities for autologous cellular immunotherapy manufacturing processes.
• Collect, organize, analyze, and present experimental and manufacturing data.
• Perform data entry and verify the accuracy of critical reports and records.
• Conduct bioassays and other analytical procedures used to characterize cellular immunotherapy products.
• Maintain accurate laboratory notebooks, study records, and supporting documentation.
• Assist in preparing technical reports to support process development, technology transfer, and regulatory submissions.
• Draft and revise standard operating procedures (SOPs), work instructions, and laboratory documentation as assigned.
• Support laboratory operations, including equipment maintenance coordination, inventory management, ordering supplies, and vendor interactions.
• Complete all required GMP, safety, and compliance training.
• Follow established safety practices and quality requirements.

Qualifications

• Bachelor's degree in Biology, Cell Biology, Biochemistry, Biotechnology, Biomedical Engineering, or a related scientific discipline is required.
• 0–2 years of relevant laboratory, biotechnology, pharmaceutical, academic research, or cell therapy experience. Internship, co-op, undergraduate research, or industry experience is preferred.
• Basic understanding of cell biology and laboratory techniques.
• Experience with cell culture, aseptic technique, or related laboratory processes preferred.
• Familiarity with GMP-regulated environments is preferred.
• Ability to follow detailed procedures and maintain accurate documentation.
• Strong analytical and problem-solving skills.
• Effective written and verbal communication skills.
• Strong organizational and time-management skills.
• Proficiency with Microsoft Office applications.
• Ability to work collaboratively in a team environment.

Additional Duties

Additional duties, as assigned.