Process Scientist-Department of Neurosurgery-GMP Lab

Process Scientist – Department of Neurosurgery – GMP Lab

• University of Florida
• United States
• Apr 18, 2026

Process Scientist/Biological Scientist III

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:

• 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. Facilitate effective dialogue across manufacturing, quality, and
  clinical teams, ensuring process development priorities are understood and integrated into program
  timelines.
• Provide 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, biosafety 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 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.

$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., Clini
  
  MACS Prodigy, Dyna Select, 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.

The University of Florida is an Equal Employment Opportunity Employer.