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Process Scientist--Department of Neurosurgery-GMP Lab

University of Florida

Gainesville, FL

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JOB DETAILS
SALARY
$70,600–$80,200 Per Year
SKILLS
Analysis Skills, Biology, Cardiovascular Disease, Cerebral Vascular Accident, Clinical Medicine, Clinical Support, Clinical Trial, Communication Skills, Continuous Improvement, Data Analysis, Delivery Management, Disease, Disease Treatment, Documentation, Experiment Design, FDA Requirements, Fellowship, GMP (Good Manufacturing Practices), ICH Regulations, Laboratory Analysis, Laboratory Management, Laboratory Operations, Leadership, Manufacturing, Manufacturing/Industrial Processes, Medical Treatment, Medicine, Mentoring, Neurology, Neurosurgery, Oncology, Operational Audit, Operations, Operations Management, Pediatrics, People Management, Presentation/Verbal Skills, Process Development, Project/Program Management, Record Keeping, Regulations, Regulatory Compliance, Reporting Skills, Research Administration, Research Laboratory, Safety Training, Scientific Research, Spinal Cord Injury, Stem Cells, Team Player, Technical Leadership, Technical Support, Technology Analysis, Training Program, Training/Teaching, Wheel/Front-End Loader, Writing Skills
LOCATION
Gainesville, FL
POSTED
Today
The Process Scientist is responsible for providing advanced scientific and technical leadership in the development, optimization, and technology transfer of advanced manufacturing processes for novel cell and RNA-based therapies. This role will focus on developing automated, closed-system platforms for cell therapy production and establishing robust mRNA manufacturing and LNP formulation processes in collaboration with research scientists.The ideal candidate will be a creative and strategic leader who thrives at the interface of discovery and clinical translation, enabling academic investigators to bring innovative therapies from the laboratory to first-in-human studies.The Lillian S. Wells Department of Neurosurgery at the University of Florida, College of Medicine is committed to providing comprehensive clinical services for the diagnosis, management, treatment, and rehabilitation of patients suffering from diseases of the brain, spinal cord, and nervous system, including brain tumors, aneurysms, stroke, epilepsy, functional disorders, and spinal disorders and injuries. Our clinical care mission also extends throughout North Central Florida through regional neurosurgery programs. We offer the full spectrum of neurosurgical and neuro-oncology treatment options for both adults and pediatric patients. Our research labs and investigator-led initiatives and clinical trials are developing promising new treatments for neurological diseases that are extremely difficult to treat with conventional therapies. The Department of Neurosurgery offers education and training programs such as ACGME-accredited neurosurgery residency programs and fellowship programs.
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

 

About the Company

U

University of Florida