The Senior Research Specialist supports filing of the BLA Application including validation and qualification of processes, material and supplies, equipment and facility processes, SOP writing, vendor qualification of manufacturing supplies and material, and other tasks as required. The Senior Research Specialist performs manufacturing of clinical trial products with an emphasis on cancer research, following cGMP regulations, performs assays including, but not limited to Endotoxin, Hemocytometer cells counts, and mycoplasma, collects and analyzes data, sets up and performs experiments and ensures operation of laboratory equipment by calibrating. They also complete preventive maintenance requirements, follow manufacturer's instructions, troubleshoot malfunctions, call for repairs, maintain equipment inventories, evaluate new equipment and techniques, troubleshoots, and diagnose and repair any issues with the equipment used in the laboratory and/or cleanroom. The Senior Research Specialist helps monitor compliance with institutional, state, and federal regulatory policies and procedures, provides back-up with the daily operations of the cleanroom, takes particle counts and preparing reports, Environmental Monitoring sampling, specialized cleaning of the facility, and processing inventory and cleanroom garments, filing, document. They also have responsibility and ownership of processing and products being manufactured, are responsible for maintaining the facility’s high standard of quality, and meeting the day-to-day scheduling needs and accomplishing departmental goals. The Senior Research Specialist has the ability to manufacture using aseptic technique, perform tissue culture, separation and preservation of serum and plasma from peripheral blood, and analyzes blood cells by counting and identifying cells, using microscopic techniques.
Applicants must have a PhD and the equivalent of two years of full-time professional research experience in a laboratory, clinical or scientific research environment; or a Master’s degree and the equivalent of four years of full-time professional research experience in a laboratory, clinical or scientific research environment; a Bachelor’s degree and the equivalent of six years of full-time professional research experience in a laboratory, clinical or scientific research environment. The preferred candidate will have proven proficiency with GTP, GLP, GMP and CGP, demonstrated hands-on experience with cellular manufacturing and a deep understanding of CMC related to cellular therapies, experience with process scale-up, experience with closed, automated manufacturing systems, and experience with a strong background in cell culture. They will also have experience and knowledge of the immune systems, experience in T cell biology, tumor immunology, and other immune components, knowledge of compliance and quality management systems, knowledge of flow cytometry and T cell phenotyping, and experience with cell transfection and transduction systems. They will have the ability to communicate effectively with managers and co-workers, to handle confidential materials, and to adhere to outlined procedures and practices and to follow specific instructions according to GMP and SOPS. They will also be able to independently learn new techniques, will have the ability to multi-task, and to prepare reports of technological findings by collecting, analyzing, and summarizing information.
This is a grant-funded position. Compliance with funding requirements such as time and effort reporting, grant deliverables, and contract deliverables is required.
Health Research Incorporated (HRI) Roswell Park Division participates in the E-Verify program.
Affirmative Action/Equal Opportunity Employer/Qualified Individuals with Disabilities/Qualified Protected Veterans
Applicants must reference the Posting # when applying for this position.
Interested applicants may apply by uploading a cover letter and resume below in Microsoft Word or PDF format.