Research Associate,Clinical Research,Medical Science Job Miami area,Florida USA,Research/Development

Position: Research Associate 3

Research Associate 3

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

CORE JOB SUMMARY

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.

CORE JOB FUNCTIONS

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.

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

Bachelor's degree in relevant field required
Minimum 5 years of relevant experience required
Learning Agility:
Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
Teamwork:
Ability to work collaboratively with others and contribute to a team environment.
Technical Proficiency:
Skilled in using office software, technology, and relevant computer applications.
Communication:
Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.

DEPARTMENT SPECIFIC JOB SUMMARY

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.

DEPARTMENT SPECIFIC JOB FUNCTIONS

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…

Research Associate, Clinical Research, Medical Science