[Hiring] Pharmaceutical Manufacturing Science & Technology Subject Matter Expert @Volga Partners

Role Description

As a Pharmaceutical Manufacturing / Manufacturing Science & Technology (MSAT) Subject Matter Expert (SME), you'll serve as a subject matter evaluator, helping assess the quality, accuracy, completeness, and scientific validity of Pharmaceutical AI-generated content.

• Evaluate AI-generated pharmaceutical content: Assess scientific, technical, and regulatory responses for accuracy, completeness, consistency, and compliance with industry standards.
• Review scientific and regulatory information: Examine content related to quality systems, manufacturing, validation, submissions, development, and compliance activities.
• Analyze technical reasoning: Determine whether AI-generated conclusions are supported by relevant scientific principles, regulatory expectations, and industry best practices.
• Identify errors and inconsistencies: Recognize unsupported claims, technical inaccuracies, missing context, and flawed reasoning.
• Validate information: Reference relevant FDA requirements, GMP regulations, ICH guidelines, and accepted pharmaceutical industry practices.
• Provide expert feedback: Clearly explain findings, identify opportunities for improvement, and recommend technically accurate corrections.
• Support AI quality improvement: Apply project-specific evaluation criteria, scoring guidelines, and quality standards.
• Complete independent evaluations: Use designated online platforms to complete assignments accurately and within established project timelines.

Qualifications

• Minimum of 4 years of professional experience in Pharmaceutical Manufacturing, Manufacturing Science & Technology (MSAT), Technical Operations, Process Engineering, Production Support, or related pharmaceutical functions.
• Bachelor's degree or higher in Pharmaceutical Sciences, Pharmacy, Chemical Engineering, Biotechnology, Chemistry, Biochemistry, Biomedical Engineering, Life Sciences, or a related discipline.
• Experience supporting pharmaceutical manufacturing operations in GMP-regulated environments.
• Experience with process monitoring, process optimization, manufacturing investigations, or technical operations support.
• Understanding of pharmaceutical production processes and manufacturing controls.
• Knowledge of FDA regulations, GMP requirements, and relevant ICH guidelines.
• Experience reviewing manufacturing documentation, batch records, process performance data, or technical reports.
• Ability to critically evaluate technical and regulatory information.
• Strong analytical, research, and problem-solving skills.
• Excellent written English communication skills.
• Ability to work independently and follow detailed review instructions.
• Comfortable working within a task-based freelance engagement model.

Requirements

• Experience supporting technology transfer from development to commercial manufacturing.
• Experience troubleshooting manufacturing deviations and process issues.
• Experience with process characterization, process validation, and continued process verification.
• Experience supporting sterile, biologic, vaccine, or oral solid dosage manufacturing operations.
• Knowledge of Lean Manufacturing, Six Sigma, Operational Excellence, or Continuous Improvement methodologies.
• Experience collaborating with Quality Assurance, Validation, Regulatory Affairs, Engineering, and Supply Chain teams.
• Experience interpreting process performance metrics and manufacturing trends.
• Experience with technical writing, investigation reports, or manufacturing documentation review.
• Familiarity with AI evaluation, data annotation, or quality review activities.
• Experience with AI model evaluation, large language models (LLMs), research, or structured quality assessments is beneficial but not required.

Benefits

• Apply your industry expertise in a new way.
• Help improve scientific accuracy.
• Work remotely with flexibility based on project needs and availability.
• Explore the future of pharmaceutical technology.
• No AI background required.