[Hiring] CMC Scientist/Technical Development Subject Matter Expert @Volga Partners

Role Description

Help Shape the Future of AI in Pharmaceutical. What if your expertise in pharmaceutical development, formulation science, process development, and technical operations could help artificial intelligence better understand how pharmaceutical products are developed, optimized, scaled, and commercialized?

As a CMC Scientist / Technical Development 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 development-focused responses for accuracy, completeness, consistency, and alignment with industry standards.
• Review pharmaceutical development information: Examine content related to formulation development, process development, manufacturing science, technology transfer, scale-up activities, and commercialization.
• Analyze scientific reasoning: Determine whether AI-generated conclusions are supported by pharmaceutical sciences, engineering principles, development methodologies, and industry best practices.
• Identify errors and inconsistencies: Recognize unsupported claims, technical inaccuracies, flawed development approaches, and missing scientific context.
• Validate information: Reference applicable FDA requirements, ICH guidelines, pharmaceutics principles, and accepted pharmaceutical development 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 Development, Technical Development, Formulation Development, Process Development, Manufacturing Sciences, or related CMC functions.
• Bachelor's degree or higher in Pharmaceutical Sciences, Pharmacy, Chemistry, Biochemistry, Chemical Engineering, Biotechnology, Biomedical Engineering, Life Sciences, or a related discipline.
• Experience supporting drug substance and/or drug product development activities.
• Experience with formulation, process development, technical operations, or manufacturing sciences.
• Understanding of pharmaceutical product development lifecycle activities.
• Familiarity with FDA regulations and relevant ICH guidelines, including development-related expectation.
• Experience interpreting scientific, technical, and manufacturing data.
• Ability to critically evaluate scientific and technical 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 with oral solid dosage, sterile, injectable, biologic, vaccine, or combination product development.
• Experience supporting technology transfer activities.
• Experience with process characterization, process optimization, or manufacturing scale-up.
• Knowledge of Quality by Design (QbD) principles and control strategy development.
• Experience with stability studies, comparability assessments, and product lifecycle management.
• Experience collaborating with Regulatory Affairs, Quality, Manufacturing, and Analytical Development teams.
• Experience with technical writing, development reports, or scientific document 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

• Use the knowledge you've developed throughout your regulatory affairs career to contribute to advanced AI technologies.
• Your expertise will help strengthen the quality and reliability of AI-generated pharmaceutical development and technical content.
• Participate in project-based assignments from an eligible location, with flexibility based on project availability.
• Gain experience contributing to AI evaluation initiatives while leveraging your existing regulatory expertise.

Company Description

Join Volga Partners and help shape the next generation of pharmaceutical AI. Apply today to be considered for upcoming project opportunities.