Process Scientist--Department of Neurosurgery-GMP Lab

Process Scientist--Department of Neurosurgery-GMP Lab

Job no: 539560
Work type: Staff Full-Time
Location: Main Campus (Gainesville, FL)
Categories: Biology/Life Science, Grant or Research Administration
Department:29190000 - MD-NEUROLOGICAL SURGERY

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.

This requisition has been reposted. Previous applicants are still under consideration and need not apply.

Health Assessment Required:Yes

Advertised: 11 May 2026 Eastern Daylight Time
Applications close: 25 May 2026 Eastern Daylight Time

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