FDA Fellowship - Applications of Artificial Intelligence, Modeling, and Simulation to Pharmaceutical Manufacturing and Product Characterization

About the role

The FDA Fellowship supports research at the intersection of artificial intelligence (AI), computational modeling, and simulation as applied to pharmaceutical manufacturing and product characterization. This opportunity aims to contribute to cutting-edge regulatory science initiatives.

Responsibilities

• Apply AI and machine learning techniques to real-world pharmaceutical manufacturing and product characterization challenges.
• Develop and evaluate computational models and simulations relevant to pharmaceutical unit operations and quality assessment.
• Interpret and analyze complex pharmaceutical process and product data to extract actionable scientific insights.
• Gain familiarity with FDA regulatory frameworks and standards governing AI- and model-based approaches in pharmaceutical manufacturing.
• Communicate research findings effectively through scientific reports, manuscripts, and presentations.
• Collaborate within a multidisciplinary research environment spanning regulatory science, engineering, and data science.

Requirements

This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals meeting specific residency criteria. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.

Qualifications

• Currently pursuing or having received a master's or doctoral degree in Life Health and Medical Sciences.
• Residing in the United States for at least 36 out of the past 60 months.

Skills

The ideal candidate should have:

• Experience with AI and machine learning techniques.
• Knowledge of computational modeling and simulation.
• Ability to interpret and analyze complex data.
• Familiarity with FDA regulatory frameworks.
• Strong communication skills.
• Collaborative and interdisciplinary work experience.

Benefits

The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program.

Pay

The participant will receive a monthly stipend commensurate with educational level and experience.

Schedule

The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.