What are the responsibilities and job description for the Research Associate-cGMP Manufacturing position at Roswell Park Comprehensive Cancer Center?
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
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
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 HR-PayAndBenefits@RoswellPark.org 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.
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
- 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.
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
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 HR-PayAndBenefits@RoswellPark.org 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.
Salary : $62,514 - $78,846