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Miami, Florida, United States
Onsite
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The Interdisciplinary Stem Cell Institute has an exciting opportunity for a full-time Research Associate 2 to work on-site in Miami, FL.
CORE JOB SUMMARY
The Research Associate 2, SOM contributes to the University’s research activities under the supervision of senior staff. Moreover, the incumbent understands, interprets, and complies with research policies and protocols.
CORE JOB FUNCTIONS
1. Performs specialized and complex experiments/studies.
2. Participates in the publication of significant research results.
3. Advances expertise through education, training, and research.
4. Writes extramural grants/proposals to gain support when appropriate.
5. Collects, prepares, analyzes, dissects, and evaluates specimens and tissue cultures.
6. Weighs and anesthetizes laboratory animals for experiments.
7. Operates sensitive and highly complex laboratory equipment.
8. Performs calculations to complete research test results.
9. Performs photography and dark room processing.
10. Participates in training sessions and workshops.
11. Adheres to University and unit-level policies and procedures and safeguards University assets.
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
CORE QUALIFICATIONS
Education:
Bachelor’s degree in relevant field required
Experience:
Minimum 2 years of relevant experience required
Knowledge, Skills and Abilities:
Department Addendum
DEPARTMENT SPECIFIC JOB SUMMARY
The Research Associate II 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.
DEPARTMENT SPECIFIC JOB FUNCTIONS
1. 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.
2. Participates in customer technology transfers and manufacturing readiness activities, including review of sponsor documentation, manufacturing workflows, and implementation of new processes as assigned.
3. 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.
4. 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).
5. Supports research and development activities, including process optimization, evaluation of new methodologies, equipment, reagents, materials, and manufacturing technologies to improve laboratory and manufacturing operations.
6. Supports departmental Quality Control (QC) activities related to manufacturing operations and assists with laboratory organization, reagent management, inventory, and general laboratory support.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. Maintains laboratory readiness through proper housekeeping, inventory management, material receipt and inspection, and coordination of supplies required for manufacturing and research activities.
13. Collaborates effectively with Quality Assurance, Quality Control, Operations, investigators, sponsors, and other institutional personnel to ensure timely execution of manufacturing and research activities.
14. May be required to work occasional evenings, weekends, or University holidays to support time-sensitive manufacturing schedules, research activities, or other operational needs.
15. Performs other duties and responsibilities as assigned.
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
DEPARTMENT PREFERRED QUALIFICATIONS
Education:
Bachelor's degree or higher in biology, Microbiology, Biomedical Engineering, Biochemistry, Cell Biology, or other life science disciplines
Experience:
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.
Knowledge, Skills and Abilities:
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 physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.
The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.
Job Status:
Full timeEmployee Type:
Staff