CMC Scientist/Technical Development Subject Matter Expert - AI Model Evaluation
V
Volga PartnersPharmaceutical development
Remote | United States | Project-Based Independent Contractor; Primary Location: United States preferred. Professionals outside the United States may be considered if they possess substantial U.S. pharmaceutical industry experience.ContractMiddle
Salary25 - 50 USD per hour
Apply NowOpens the employer's application page
Job Details
- Languages
- Excellent written English communication skills
- Experience
- Minimum of 4 years of professional experience in Pharmaceutical Development, Technical Development, Formulation Development, Process Development, Manufacturing Sciences, or related CMC functions
Requirements
- Have a minimum of 4 years of professional experience in Pharmaceutical Development, Technical Development, Formulation Development, Process Development, Manufacturing Sciences, or related CMC functions.
- Hold a bachelor’s degree or higher in Pharmaceutical Sciences, Pharmacy, Chemistry, Biochemistry, Chemical Engineering, Biotechnology, Biomedical Engineering, Life Sciences, or a related discipline.
- Have experience supporting drug substance and/or drug product development activities.
- Have experience with formulation, process development, technical operations, or manufacturing sciences.
- Understand pharmaceutical product development lifecycle activities.
- Be familiar with FDA regulations and relevant ICH guidelines, including development-related expectations.
- Have experience interpreting scientific, technical, and manufacturing data.
- Be able to critically evaluate scientific and technical information.
- Have strong analytical, research, and problem-solving skills.
- Have excellent written English communication skills.
- Be able to work independently and follow detailed review instructions.
- Be comfortable working within a task-based freelance engagement model.
Responsibilities
- Evaluate AI-generated pharmaceutical responses for accuracy, completeness, consistency, and alignment with industry standards.
- Review content related to formulation development, process development, manufacturing science, technology transfer, scale-up, and commercialization.
- Assess whether AI-generated conclusions are supported by pharmaceutical sciences, engineering principles, development methodologies, and industry best practices.
- Identify unsupported claims, technical inaccuracies, flawed development approaches, and missing scientific context.
- Validate information against applicable FDA requirements, ICH guidelines, pharmaceutics principles, and accepted pharmaceutical development practices.
- Explain findings, identify opportunities for improvement, and recommend technically accurate corrections.
- Apply project-specific evaluation criteria, scoring guidelines, and quality standards.
- Complete independent evaluations using designated online platforms within established project timelines.
View Full Description & ApplyYou'll be redirected to the employer's site
