Executive, R&D Injectable (AI/ML)

Key Responsibilities

• Develop and implement AI/ML models for data extraction, validation, and analysis (documents, chromatograms, lab data)
• Build NLP-based solutions for semantic search, document processing, and structured data generation
• Implement AI-driven anomaly detection, trend analysis, and predictive insights
• Enable AI use cases across MVS, LIMS, ELN, QMS, and Excel validation systems
• Evaluate and validate vendor AI solutions:
  • Verify accuracy, reliability, and performance
  • Design validation scenarios and test datasets
  • Review model logic and outputs
  • Identify risks, gaps, and compliance issues
• Support system integration (LIMS, ELN, QMS, SAP) and data harmonization
• Ensure compliance with GxP, Data Integrity (ALCOA+), and 21 CFR Part 11
• Support Computer System Validation (CSV) and audit readiness

Required Skills

• Strong programming in Python
• Experience in Machine Learning & AI model development
• Knowledge of NLP (document extraction, semantic search)
• Exposure to OCR / data extraction from PDFs
• Experience with TensorFlow / PyTorch
• Understanding of model validation, statistics, and data analysis
• Basic knowledge of APIs and system integration

Preferred Domain Knowledge

• Exposure to LIMS, ELN, QMS, SAP, or MVS systems
• Understanding of Method / Analytical Validation
• Experience in Excel validation / CSV processes
• Knowledge of GxP and Data Integrity

Experience & Qualification

• Minimum 3 years of AI/ML experience
• Pharma / Healthcare domain preferred
• Degree in AI / Data Science / Computer Science
  OR Pharma background with AI experience

Key Competencies

• Strong analytical and problem-solving skills
• Ability to evaluate and challenge vendor solutions
• Good communication and documentation skills
• Comfortable working in a regulated environment

• B. Pharm B. Pharm - Required

• M. Pharm M. Pharm - Preferred

• 5 years or more in 5 - 8 Years