Amneal Pharmaceuticals

Executive, R&D Injectable (AI/ML)

Amneal Pharmaceuticals  •  State of Gujarāt, IN (Onsite)  •  1 day ago
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Job Description

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

Education:

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

Experience:

  • 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses: 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.

Amneal Pharmaceuticals

About Amneal Pharmaceuticals

Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.

Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.

Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.

Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.

Industry
Chemicals & Materials
Company Size
5,001-10,000 employees
Headquarters
Bridgewater, New Jersey
Year Founded
2002
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