Research Associate-cGMP Manufacturing

Roswell Park Comprehensive Cancer Center

19h•Onsite

About The Position

The Research Associate supports manufacturing for cGMP operations. The role will lead manufacturing operations for specific protocols within the clean room facility. The Research Associate is responsible for performing manufacturing, formulation, filling, packaging, or support activities within a regulated GMP clean room environment. This role ensures that all operations are conducted in compliance with cGMP, SOPs, safety requirements, and customer-specific quality expectations, while maintaining strict contamination control standards.

Requirements

Master’s degree and the equivalent of eighteen (18) months of full-time professional research experience in a laboratory, clinical or scientific research environment; or
Bachelor’s degree and the equivalent of thirty (30) months of full-time professional research experience in a laboratory, clinical or scientific research environment.
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.

Nice To Haves

Hands-on handling of the manufacture of cell therapy products (dendritic, T cells) for clinical studies, working the GMP cleanroom environment, and BSC
Knowledge of FACT, cGMP, and FDA biologics regulations
Knowledge of commonly utilized tools in cell therapy or blood processing laboratories (examples CliniMACS Plus and CliniMACS Prodigy, Cocoon, Manual Ficoll, PCR/ qPCR).
Experience with technical documentation, Standard Operating Procedures (SOP), Batch Record (BR) and report writing
Team/trainer in GMP setting
Ability to work for extended periods in full clean room gowning
Ability to stand for long durations and perform repetitive tasks
Ability to work shifts, weekends, and overtime as required
Flexibility and adaptability to changing schedules or priorities

Responsibilities

Support daily operations of clean room facility
Execute assigned manufacturing or support tasks within classified clean rooms
Perform activities such as aseptic processing, filling, inspection, labeling, or packaging as applicable.
Operate manufacturing equipment according to approved procedures and batch records.
Accurately complete GMP documentation, including batch records, LIMS and cleaning records in real time.
Identify and report deviations, nonconformances, or abnormal conditions immediately.
Participate in deviation investigations, CAPAs, change controls, and audits (internal, client, regulatory).
Properly gown, degown, and maintain gowning integrity per clean room classification requirements.
Maintain clean room cleanliness, including routine cleaning and sanitization activities.
Review EMS and BMS data
Ensure all materials are ready and on hand for operations
Work collaboratively with Manufacturing, Quality, Engineering, and Supply Chain teams.
Train teammates