Research Fellow Full-time

On-Site

Full time

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The Interdisciplinary Stem Cell Institute has an exciting opportunity for a full-time Research Associate 3 to work on-site in Miami, FL.

The Research Associate 3, SOM assumes responsibility for the design and performance of research focused on the development of novel experimental therapies for human malignancies. The incumbent contributes to collaborations with scientists within the University of Miami or elsewhere. Moreover, this individual works as part of a team and assists with the maintenance of laboratory equipment, protocols, and supplies.

Maintains daily operations and performs procedures related to new and on-going research projects.Assists with ordering, purchasing, and maintenance of all required reagents and supplies for laboratory activities, and monitors and maintains inventory of supplies and stocks.Assists with the maintenance of institutional biosafety and animal care protocols, laboratory safety records, and standard operating procedures.Performs and assists other research staff with standard laboratory techniques.Develops, adapts, and implements new laboratory procedures.Records, organizes, and writes up experimental results for submission of manuscripts and for scientific presentations.Keeps abreast of latest literature in the field and searches for references to technical problems.Maintains current knowledge of the methods and techniques related to the specific field of research.Adheres to University and unit-level policies and procedures and safeguards University assets.CORE QUALIFICATIONSEducation:Bachelor’s degree in relevant field requiredExperience:Minimum 5 years of relevant experience requiredKnowledge, Skills and Abilities:

Skilled in using office software, technology, and relevant computer applications.

The Research Associate III supports the operational, manufacturing, and research activities of the Cell Manufacturing Program (CMP) within the Interdisciplinary Stem Cell Institute's Comprehensive Research Cell Manufacturing Program (CRCMP). Approximately 80% of responsibilities are dedicated to the manufacture of various investigational cellular therapy products under current Good Manufacturing Practice (cGMP) regulations, with the remaining 20% supporting research and development activities.

Under the supervision of qualified personnel until departmental qualification requirements have been met, the incumbent performs aseptic manufacturing operations, executes controlled laboratory procedures, supports quality control and validation activities, maintains accurate GMP documentation, and participates in continuous process improvement initiatives. The position requires strict adherence to FDA regulations, institutional policies, cGMP requirements, and the CRCMP Quality Management System while ensuring product quality, patient safety, and regulatory compliance.

Performs aseptic manufacturing, processing, cryopreservation, storage, packaging, and shipment of various investigational cellular therapy products in accordance with approved manufacturing records, Standard Operating Procedures (SOPs), cGMP regulations, and departmental quality requirements.Participates in customer technology transfers and manufacturing readiness activities, including review of sponsor documentation, manufacturing workflows, and implementation of new processes as assigned.Successfully completes and maintains all required departmental training, competency assessments, and annual qualifications, including documentation of a color vision examination as required for designated manufacturing and quality-related activities.Maintains complete, accurate, and contemporaneous GMP documentation, including manufacturing records, controlled forms, equipment logs, laboratory records, and electronic documentation in accordance with Good Documentation Practices (GDP).Supports research and development activities, including process optimization, evaluation of new methodologies, equipment, reagents, materials, and manufacturing technologies to improve laboratory and manufacturing operations.Supports departmental Quality Control (QC) activities related to manufacturing operations and assists with laboratory organization, reagent management, inventory, and general laboratory support.Participates in qualification and validation activities including equipment qualification, process qualification, method qualification, aseptic process qualification, operator qualification, and the facility Environmental Monitoring (EM) Program.Assists with the preparation, revision, implementation, periodic review, and continuous improvement of Standard Operating Procedures (SOPs), batch records, forms, work instructions, technical reports, and other controlled quality system documentation.Participates in deviation investigations, corrective and preventive actions (CAPA), change controls, risk assessments, and other Quality Management System activities to support regulatory compliance and continuous improvement.Maintains compliance with applicable FDA regulations, cGMP requirements, institutional policies, biosafety requirements, and departmental quality standards while supporting internal, external, customer, and regulatory inspections and audits.Assists with laboratory equipment management activities and participates in the department's rotating equipment monitoring on-call schedule to respond to critical monitoring system alarms and equipment notifications as required.Maintains laboratory readiness through proper housekeeping, inventory management, material receipt and inspection, and coordination of supplies required for manufacturing and research activities.Collaborates effectively with Quality Assurance, Quality Control, Operations, investigators, sponsors, and other institutional personnel to ensure timely execution of manufacturing and research activities.May be required to work occasional evenings, weekends, or University holidays to support time-sensitive manufacturing schedules, research activities, or other operational needs.Education:

Bachelor's degree or higher in biology, Microbiology, Biomedical Engineering, Biochemistry, Cell Biology, or other life science disciplines

Experience in mammalian cell culture and aseptic laboratory techniques preferred.

Experience working in a regulated laboratory or manufacturing environment preferred.

Experience with Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and quality systems preferred.

Experience with investigational cellular therapy manufacturing or translational research is desirable.

Ability to prioritize multiple assignments while maintaining quality and compliance.

Proficiency with Microsoft Office and electronic documentation systems.

Ability to learn new laboratory techniques, manufacturing technologies, and regulatory requirements.

Commitment to maintaining the highest standards of product quality, patient safety, and regulatory compliance.

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. The University of Miami is an Equal Opportunity Employer. Full time

The mission of the University of Miami is to transform lives through education, research, innovation, and service. A vibrant and diverse academic and healthcare community, the University of Miami and the University of Miami Health System ("UHealth") have rapidly progressed to become one of the nation’s top research universities and academic medical centers in the nation.

The University comprises 12 schools and colleges serving undergraduate and graduate students in more than 350 majors and programs. The University ranks No. News & World Report’s 2022 Best Colleges list and ranked No. 49 in the 2022 Wall Street Journal/Times Higher Education College Rankings.

Bascom Palmer Eye Institute is ranked the #1 eye hospital in the USA and offers some of the nation's premiere eye doctors to treat every eye condition for adults. Sylvester Comprehensive Cancer, part of the Miller School of Medicine, received the prestigious National Cancer Institute designation in 2019.

The University of Miami and UHealth have also ranked among the Forbes Best Employers and Best Employers for Women on several occasions, most recently in 2022.

With more than 17,000 faculty and staff, the University strives for excellence, and is driven by a powerful mission to transform and impact the lives of its students, patients, members of the community, and people across the globe.

The University of Miami is an Equal Opportunity Employer.