CMC, Manufacturing & Quality Expert

Join a leading AI lab's cutting-edge GenAI team to be at the core of the AI revolution, where your expertise fuels the development of the most advanced Large Language Models.

Overview

Join a leading AI lab's cutting-edge GenAI team and help build foundational AI models from the ground up. We're seeking talented CMC, Manufacturing and Quality subject-matter experts (SMEs) from the pharmaceutical and biotech industry to bring deep expertise in drug development, GMP manufacturing and quality systems and elevate the quality of our AI training data. This is a full-time commitment of 40 hours per week.

This is a W-2 employment position with Cincinnatus LLC, with the opportunity to be placed at a leading AI Lab as part of their extended workforce.

Key Responsibilities

• Guide research and engineering teams to close knowledge gaps and improve AI model performance in chemistry, manufacturing and controls (CMC), GMP manufacturing, and pharmaceutical quality systems.
• Design challenging, realistic CMC and quality tasks, such as process development and scale-up problems, deviation and CAPA investigations, tech transfer scenarios and CMC submission questions, and write accurate, well-structured solutions.
• Evaluate AI model outputs on CMC and quality questions for accuracy against cGMP (21 CFR 210/211), ICH Q-series guidelines and real manufacturing practice, and provide clear, written feedback.
• Develop guidelines and detailed rubrics to assess root-cause reasoning, control strategy design, and CMC regulatory content across tasks.
• Collaborate with other subject matter experts to ensure consistency and accuracy in training data.