Analysis Skills, Biology, Clinical Support, Communication Skills, Continuous Improvement, Data Analysis, Delivery Management, Documentation, Experiment Design, FDA Requirements, GMP (Good Manufacturing Practices), ICH Regulations, Laboratory Analysis, Laboratory Management, Laboratory Operations, Leadership, Manufacturing, Mentoring, Neurosurgery, Operational Audit, Operations, Operations Management, People Management, Presentation/Verbal Skills, Process Development, Project/Program Management, Record Keeping, Regulations, Regulatory Compliance, Reporting Skills, Research Administration, Safety Training, Scientific Research, Stem Cells, Team Player, Technical Support, Technology Analysis, Wheel/Front-End Loader, Writing Skills
Classification Title:
Process Scientist/Biological Scientist III
Classification Minimum 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.
Job Description:
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.
Expected Salary:
$70,600-$80,200
Required Qualifications:
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.
Preferred:
- 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.
Special Instructions to Applicants:
For consideration, please complete an application and include a cover letter, resume and the names and email addresses of three to five references.
The University of Florida is an Equal Employment Opportunity Employer.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required: Yes