CMC, Manufacturing & Quality Expert

1\. 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.

2\. 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.

3\. Core Qualifications

• 7+ years of dedicated professional experience in CMC, manufacturing, process development or quality (QA/QC) for small molecules, biologics or advanced therapies at a recognized, top-tier organization (e.g., a top-25 pharmaceutical company such as Pfizer, Merck, Roche, Novartis, AstraZeneca, Johnson & Johnson, AbbVie, Eli Lilly, Bristol Myers Squibb, Sanofi or GSK; a major biotech such as Amgen, Gilead, Genentech, Regeneron, Vertex or Biogen; a leading CRO such as IQVIA, ICON, Parexel, Syneos Health, PPD/Thermo Fisher, Labcorp/Fortrea or Medpace; or a regulator such as the FDA or EMA).
• Hands-on experience in at least one of: GMP manufacturing operations, process development and scale-up, technology transfer, or QA/QC (deviations, CAPA, batch release, validation).
• Experience authoring or reviewing CMC regulatory content (eCTD Module 3 or IND and NDA/BLA quality sections), with working knowledge of cGMP and ICH Q8 to Q11.
• Current or most recent role at Senior Manager or Associate Director level or above, with demonstrable career progression (e.g., Process Engineer or QA Specialist → Manager → Senior Manager, Manufacturing Science or Quality → Associate Director → Director, CMC or Quality).
• Ability to engage reliably for at least 40 hours/week during weekdays.
• Experience with AI training or evaluation work, or hands-on use of AI tools in manufacturing or quality work, is a plus.
• Strong written communication skills and the ability to explain complex technical and quality decisions clearly.

About Cincinnatus LLC

Cincinnatus LLC is an enterprise staffing company that partners with leading technology companies to source and employ highly skilled professionals for contingent and contract-based opportunities. Cincinnatus serves as the employer of record for these engagements, providing W-2 employment, payroll, benefits, and compliance, while placing employees directly within client teams to work on high-impact initiatives.

Equal Employment Opportunity

Cincinnatus is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, reproductive health decisions, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetic information, political views or activity, or any other legally protected characteristic.

Where you can work

This role is 100% remote, for applicants located in United States.