Summer Intern

Summer Internship Overview

This internship provides an educational introduction to biopharmaceutical process development within a regulated manufacturing environment. The intern will gain exposure to core concepts in immunology, cell-based therapies, and manufacturing process design through structured training, observation, and supervised non‑hazardous assignments.

The role is intentionally designed to ensure compliance with federal and state youth employment laws and does not involve hands‑on laboratory work with biological materials.

Key Learning Objectives

The intern will:

• Learn foundational principles of immunology relevant to cell‑based therapies
• Understand the end‑to‑end lifecycle of a cell therapy manufacturing process
• Gain exposure to how process improvements are conceptualized, evaluated, and supported by data
• Develop analytical and professional skills in a regulated scientific environment

Responsibilities

Under close supervision, the intern will:

• Training & Education
  • Participate in training on aseptic techniques, cell culture theory, and biosafety principles (theoretical learning only)
  • Receive instruction on Good Manufacturing Practice (GMP) concepts and documentation standards
  • Learn process development terminology, workflows, and quality considerations
• Observation & Shadowing
  • Observe laboratory activities and manufacturing processes from designated nonrestricted areas
  • Shadow scientists and engineers during planning discussions, data reviews, and process design meetings
  • Observe demonstrations of laboratory techniques without handling equipment, materials, or samples
• Data & Process Analysis
  • Analyze existing, de-identified manufacturing and process‑development data
  • Use statistical or analytical software (e.g., Excel or similar tools) to support process improvement projects
  • Assist in identifying trends, bottlenecks, or opportunities for process optimization based on provided datasets
• Documentation & Project Support
  • Support preparation of reports, presentations, and summaries related to process improvement initiatives
  • Assist with SOP review, process mapping, and documentation updates (nontechnical drafting)
  • Contribute to project tracking and knowledge management activities

Explicit Exclusions (For Clarity and Compliance)

The intern will not:

• Perform hands‑on laboratory work
• Handle biological materials, cell lines, reagents, or waste
• Work inside biosafety cabinets or controlled laboratory spaces
• Participate directly in cell culture, viral work, or manufacturing operations
• Enter restricted lab areas where biohazardous materials are present

Skills & Qualifications

• Interest in biology, biotechnology, bioengineering, or data analysis
• Strong attention to detail and willingness to learn in a regulated environment
• Basic computer skills; familiarity with spreadsheets or basic statistics is a plus
• Ability to follow safety instructions and comply with all supervision requirements

Supervision & Safety

• All activities are conducted under direct and close supervision
• The internship structure complies with federal and Colorado youth employment laws
• Safety, education, and compliance are prioritized at all times