Pharmaceutical Manufacturing Science & Technology Subject Matter Expert – AI

This is a fully remote position, open to applicants in United States.

📋 Description

• Assess AI-generated pharmaceutical content for scientific, technical, and regulatory precision, comprehensiveness, consistency, and adherence to compliance standards.

• Examine information pertaining to quality systems, manufacturing, validation, submissions, development, and compliance activities.

• Evaluate whether AI-generated conclusions align with scientific principles, regulatory standards, and industry best practices.

• Detect unsupported assertions, technical inaccuracies, gaps in context, and flawed logic.

• Reference FDA requirements, GMP regulations, ICH guidelines, and recognized practices within the pharmaceutical industry.

• Offer expert insights, clarify findings, and suggest technically accurate amendments.

• Implement project-specific evaluation criteria, scoring metrics, and quality benchmarks.

• Conduct independent assessments using designated online platforms within the established project timelines.

⛳️ Requirements

• A minimum of 4 years of professional experience in Pharmaceutical Manufacturing, Manufacturing Science & Technology (MSAT), Technical Operations, Process Engineering, Production Support, or related pharmaceutical roles.

• A Bachelor's degree or higher in Pharmaceutical Sciences, Pharmacy, Chemical Engineering, Biotechnology, Chemistry, Biochemistry, Biomedical Engineering, Life Sciences, or a similar field.

• Experience in supporting pharmaceutical manufacturing operations in GMP-compliant environments.

• Proficient in process monitoring, process optimization, manufacturing investigations, or technical operations support.

• Knowledge of pharmaceutical production processes and manufacturing controls.

• Familiarity with FDA regulations, GMP standards, and applicable ICH guidelines.

• Experience reviewing manufacturing documentation, batch records, process performance data, or technical reports.

• Ability to critically assess technical and regulatory documentation.

• Strong analytical, research, and problem-solving capabilities.

• Exceptional written communication skills in English.

• Capacity to work autonomously while adhering to detailed review protocols.

• Comfortable operating within a task-based freelance model.

• Preferred: PharmD, MS, MBA, PhD, or other advanced scientific qualifications.

• Preferred: Experience in facilitating technology transfer from development to commercial manufacturing.

• Preferred: Background in troubleshooting manufacturing deviations and process challenges.

• Preferred: Experience with process characterization, validation, and ongoing process verification.

• Preferred: Exposure to supporting sterile, biologic, vaccine, or oral solid dosage manufacturing operations.

• Preferred: Knowledge of Lean Manufacturing, Six Sigma, Operational Excellence, or Continuous Improvement methodologies.

• Preferred: Experience collaborating with Quality Assurance, Validation, Regulatory Affairs, Engineering, and Supply Chain teams.

• Preferred: Experience interpreting process performance metrics and manufacturing trends.

• Preferred: Experience in technical writing, investigation reports, or reviewing manufacturing documentation.

• Preferred: Familiarity with AI evaluation, data annotation, or quality review activities.

🏝️ Benefits

• Remote work arrangement.

• Flexible, assignment-based schedule.

• Opportunity to contribute to cutting-edge AI technologies.

• Supplemental-income freelance engagement.

• Experience in contributing to AI evaluation initiatives.