Process Scientist--Department of Neurosurgery-GMP Lab

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