Executive, R&D Injectable (AI/ML)

Key Responsibilities

JOB DESCRIPTION

• 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
  
  

Education

QUALIFICATIONS

• B. Pharm B. Pharm - Required
• M. Pharm M. Pharm - Preferred
  
  

Experience:

• 5 years or more in 5 - 8 Years
  
  

Specialized Knowledge: Licenses:

About Us

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

About The Team

The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

Key Roles That The Human Resources Team Performs

Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.

Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.

Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.

Consultancy Role: Provide expert advice to the organization and it's managers on any aspect of workforce management and employee relations and performance.

Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.