Research Technologist – Analytical Development and Quality Control (GMP)

Title:

Research Technologist – Analytical Development and Quality Control (GMP)

Job Type:

Regular

Company:

Health Research, Inc. (HRI) Roswell Park Division

Department:

Center for Immunotherapy

Time Type:

Full time

Weekly Hours:

40

FTE:

1

Shift:

First Shift (United States of America)

Summary:

Join a mission-driven team at the forefront of cutting-edge cell and gene therapies. At Roswell Park’s state-of-the-art GMP Engineering & Cell Manufacturing (GEM) Facility, we are pioneering advanced immunotherapies like CAR-T with the goal of transforming patient care.

We are seeking a Research Technologist to play a key role in Analytical Development and Quality Control for the release testing of cell therapy products. This is a hands-on, lab-based position within a dynamic cGMP environment, ideally suited for individuals passionate about cellular therapeutics and high-impact translational research.

Key Responsibilities:

•Execute analytical development and QC release testing of cell and gene therapy products under cGMP conditions, including endotoxin, sterility, qPCR, dPCR and potency assays.
•Draft, Review and maintain Standard Operating Procedure (SOPs), worksheets, forms, and QC release reports.
•Set up, calibrate and maintain QC instruments, perform Preventative Maintenance, and/or conduction of IQ/OQ/PQ.
•Ensure compliance with GMP/FDA guidelines and regulatory requirements for product release
•Collaborate cross-functionally with Manufacturing Sciences, Process Development, Vector Development, and Quality Assurance teams to ensure seamless technology transfer, method suitability and qualification studies.
•Contribute to continuous improvement initiatives to optimize processes and ensure readiness for clinical trial demands and regulatory audits.

What You’ll Bring:
•A strong foundation in cell culture and aseptic technique, ideally in a cGMP or regulated environment.
•A detail-oriented mindset with a commitment to quality and operational excellence.
•Effective communication and teamwork skills to support cross-departmental projects.
•Adaptability and drive to work in a fast-paced, evolving field at the intersection of science and medicine.

Why Roswell Park?
•Be part of a nationally recognized cancer center with a legacy of innovation and patient-centered care.
•Access to world-class facilities, resources, and training to support your professional growth.
•The opportunity to directly contribute to life-saving therapies that make a difference in patients’ lives.

Behavioral & Professional Competencies:
•Strong interpersonal skills and the ability to communicate clearly across functions and teams.
•Highly organized with the ability to manage multiple tasks and meet tight deadlines.
•Excellent verbal and written communication skills.
•Resourceful and solutions-focused mindset with a strong sense of ownership.
•Adaptable and resilient in a fast-paced, mission-critical setting.

The starting annual compensation for this position is $50,456 and this includes a full comprehensive benefits package.

Qualifications:

Required Education and Experience
1. Master’s degree in a clinical or scientific discipline; or
2. Bachelor’s degree in a clinical or scientific discipline and the equivalent of one (1) year of full-time experience in a laboratory setting.

NOTE:
Required degrees must have been granted by an accredited school, college or university or one recognized by Roswell Park Comprehensive Cancer Center as following acceptable educational practices.

• Extensive experience in Analytical Development or Quality Control settings
• Demonstrated proficiency in cellular and molecular assays, such as flow cytometry, cytotoxicity, qPCR, dPCR, ELISA, and a strong analytical mindset and troubleshooting capabilities.
• Working knowledge of cGMP standards, FDA/EU/ICH guidelines related to manufacturing of cell-based products is strongly preferred.
• Solid foundation in aseptic technique and mammalian cell culture, with a track record of maintaining sterility and culture integrity in high-throughput or regulated settings.
• Strong communication skills, with the ability to convey scientific concepts clearly across cross-functional teams; collaborative, articulate, and committed to scientific excellence.
• Hands-on experience in cell therapy such as CAR-T, stem cell-based platforms, or other adaptive cell transfer modalities spanning research, process development, or manufacturing.
• Exceptional attention to detail, especially in documentation, cleanliness, and organization critical qualities for maintaining reproducibility and regulatory compliance.