Process Scientist--Department of Neurosurgery-GMP Lab

University of Florida•Gainesville, FL

About The Position

Process Development, Experimental Design & Optimization Lead the design, optimization, and scale-up of automated, closed-system processes for dendritic cell, CAR T, autologous T cells, and stem cell-based products. Evaluate and integrate novel technologies (e.g., automated selection and transduction systems, closed culture platforms) to enhance robustness, reproducibility, and compliance with GMP standards. Develop and optimize RNA synthesis workflows, including IVT, purification, and capping strategies, to support preclinical and clinical supply. Collaborate with formulation scientists to establish scalable, reproducible LNP formulation processes tailored for diverse therapeutic payloads. Define and monitor critical process parameters (CPPs) and critical quality attributes (CQAs) to ensure consistent product quality and regulatory readiness. Partner with the manufacturing team for operator training and investigations. Author process development and qualification protocols and manufacturing batch record in accordance with phase-appropriate GMP standards. Facilitates effective dialogue across manufacturing, quality, and clinical teams, ensuring process development priorities are understood and integrated into program timelines Provides scientific and strategic leadership for the analytical function, mentoring junior scientists and fostering a culture of rigor, accountability, and innovation Collaborate with equipment vendors, CDMOs, and technology providers to evaluate platforms, execute tech transfers and manage deliverables. Research Compliance, GMP Alignment & Documentation Administer biological research activities in accordance with approved protocols, bio-safety requirements, and institutional policies. Author and maintain process development documentation, qualification protocols, standard operating procedures (SOPs), and manufacturing batch records as applicable. Support alignment with phase-appropriate GMP expectations and regulatory readiness for translational research activities. Laboratory Operations & Personnel Supervision Manage daily laboratory operations, including the cultivation and study of live specimens, equipment use, and resource coordination. Train, and direct the work of research staff, postdoctoral fellows, graduate students, and technical personnel. Support operator training, deviation investigations, and continuous improvement initiatives in collaboration with manufacturing and research teams. Collaboration, Technology Evaluation & External Partnerships Collaborate with equipment vendors, CDMOs, and technology providers to evaluate platforms, execute tech transfers and manage deliverables. Collaborate with interdisciplinary teams to analyze scientific and operational challenges and recommend solutions. Support technology transfer activities and manage deliverables with external collaborators. Scientific Communication & Research Support Maintain accurate laboratory records and analyze research data in accordance with institutional and funding requirements. Prepare reports, presentations, and documentation to communicate research results to internal and external stakeholders. Contribute to grant applications, manuscripts, and other research advancement activities as assigned.

Requirements

Bachelor's degree in biology or a related field and seven years of experience or master's degree in biology or a related field with five years of experience.
Doctoral degree in biology or related field with two years of experience.

Nice To Haves

Hands-on expertise with closed-system cell processing platforms (e.g., CliniMACS Prodigy, DynaSelect, or equivalent) and associated unit operations.
Experience in RNA manufacturing (IVT, purification) and LNP formulation techniques.
Demonstrated track record of leading process development from research to GMP readiness.
Strong understanding of GMP principles, regulatory expectations (FDA/EMA/ICH), and quality systems.
Excellent leadership, project management, and communication skills with a proven ability to collaborate across disciplines.

Responsibilities

Lead the design, optimization, and scale-up of automated, closed-system processes for dendritic cell, CAR T, autologous T cells, and stem cell-based products.
Evaluate and integrate novel technologies (e.g., automated selection and transduction systems, closed culture platforms) to enhance robustness, reproducibility, and compliance with GMP standards.
Develop and optimize RNA synthesis workflows, including IVT, purification, and capping strategies, to support preclinical and clinical supply.
Collaborate with formulation scientists to establish scalable, reproducible LNP formulation processes tailored for diverse therapeutic payloads.
Define and monitor critical process parameters (CPPs) and critical quality attributes (CQAs) to ensure consistent product quality and regulatory readiness.
Partner with the manufacturing team for operator training and investigations.
Author process development and qualification protocols and manufacturing batch record in accordance with phase-appropriate GMP standards.
Facilitates effective dialogue across manufacturing, quality, and clinical teams, ensuring process development priorities are understood and integrated into program timelines
Provides scientific and strategic leadership for the analytical function, mentoring junior scientists and fostering a culture of rigor, accountability, and innovation
Collaborate with equipment vendors, CDMOs, and technology providers to evaluate platforms, execute tech transfers and manage deliverables.
Administer biological research activities in accordance with approved protocols, bio-safety requirements, and institutional policies.
Author and maintain process development documentation, qualification protocols, standard operating procedures (SOPs), and manufacturing batch records as applicable.
Support alignment with phase-appropriate GMP expectations and regulatory readiness for translational research activities.
Manage daily laboratory operations, including the cultivation and study of live specimens, equipment use, and resource coordination.
Train, and direct the work of research staff, postdoctoral fellows, graduate students, and technical personnel.
Support operator training, deviation investigations, and continuous improvement initiatives in collaboration with manufacturing and research teams.
Collaborate with equipment vendors, CDMOs, and technology providers to evaluate platforms, execute tech transfers and manage deliverables.
Collaborate with interdisciplinary teams to analyze scientific and operational challenges and recommend solutions.
Support technology transfer activities and manage deliverables with external collaborators.
Maintain accurate laboratory records and analyze research data in accordance with institutional and funding requirements.
Prepare reports, presentations, and documentation to communicate research results to internal and external stakeholders.
Contribute to grant applications, manuscripts, and other research advancement activities as assigned.