Research Associate-cGMP Manufacturing

Research Associate-cGMP Manufacturing Roswell Park Cancer Institute - 3.7 Buffalo, NY Job Details Full-time $62,514 - $78,846 a year 1 day ago Qualifications Scientific research

Full Job Description Title:

Research Associate-cGMP Manufacturing 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:

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. Salary range for this position is $62,514 - $78,846 which includes a comprehensive benefits package. The listed pay range reflects the range of potential compensation for this role. The actual offer may vary based on qualifications, skills, and experience. Primary duties of this role include: 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

Qualifications:

Required Education and Experience 1. 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 2. Bachelor's degree and the equivalent of thirty (30) months of full-time professional research experience in a laboratory, clinical or scientific research environment.

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.

Preferred Qualifications:

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 Equal Employment Opportunity Statement Roswell Park Cancer Institute Corporation (RPCIC) and Health Research Inc. (HRI) Roswell Park Division believe that all persons are entitled to equal employment opportunities, and we do not discriminate against our employees, applicants or job seekers because of their race, color, religion, sex, sexual orientation, gender identity or expression, national origin, creed, age, disability, pregnancy-related condition, military or veteran status, marital or familial status, domestic violence victim status, citizenship status, genetic information, individual's relationship or association with a member of a protected category or any other protected group status as defined by law. Affirmative Action/Equal Opportunity Employer/Qualified Individuals with Disabilities/Qualified Protected Veterans Reasonable Accommodation Request RPCIC and HRI are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email and let us know the nature of your request and your contact information. Our Core Values RPCIC and HRI are committed to providing an environment where patients, families, employees and community are treated with courtesy and respect. We support an inclusive environment that nurtures the talents, skills and abilities of each individual to embody and reflect our core values: Innovation, Integrity, Teamwork, Commitment, Compassion and Respect. Grant Funding This is a grant-funded position. Compliance with funding requirements such as time and effort reporting, grant deliverables, and contract deliverables is required. E-Verify Employer Health Research Inc. (HRI) Roswell Park Division participates in the E-Verify program.