Research Associate 3

University of Miami•Miami, FL

3d•Onsite

About The Position

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. 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.

Requirements

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.

Nice To Haves

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.
Knowledge of aseptic technique and cell culture principles.
Knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
Ability to accurately follow written procedures and manufacturing instructions.
Strong attention to detail and commitment to documentation accuracy.
Ability to prioritize multiple assignments while maintaining quality and compliance.
Strong analytical and troubleshooting skills.
Excellent written and verbal communication skills.
Ability to work independently following qualifications while functioning effectively as part of a multidisciplinary team.
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.

Responsibilities

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.
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.
Performs other duties and responsibilities as assigned.