Domain SME Lead
Job Description looking for AI Lead to drive the development and deployment of next-generation agentic AI solutions for pharmaceutical analytical method validation and CDMO operations. Lead technical workstreams using Azure OpenAI GPT-5, LangGraph frameworks, and intelligent document processing for HPLC method development, protocol generation, and regulatory compliance automation. Strong Azure cloud architecture expertise required with hands-on development approach using Claude Code. Required Qualifications 10+ years of experience in AI/ML engineering with 4+ years in agentic AI and LLM systems Proven Azure cloud architecture expertise with Azure Solutions Architect certification preferred Hands-on development experience using Claude Code for rapid AI prototyping and implementation Strong proficiency in LangGraph, LangMem, and agentic workflow development Experience with Azure OpenAI GPT-5, text-embedding-3-large, and Azure AI services Extensive experience in LLM evaluation and testing (LangGraph evals, Agent evals, DeepEval, prompt testing frameworks) Experience with LlamaIndex (LlamaParse, LlamaExtract) for scientific document processing Deep understanding of pharmaceutical regulatory requirements (FDA, EMA, ICH guidelines) Key Responsibilities Design Azure-native agentic AI applications for HPLC method validation and protocol generation Lead hands-on development using Claude Code for pharmaceutical workflow automation Build intelligent document processing pipelines for method protocols, validation reports, and regulatory submissions Establish comprehensive LLM testing and evaluation frameworks for pharmaceutical accuracy and compliance Implement advanced RAG systems for pharmaceutical knowledge bases and method libraries Fine-tune Azure OpenAI GPT-5 models for pharmaceutical terminology and scientific accuracy Design Azure infrastructure for Veeva Vault, Egnyte, and LIMS integration Collaborate with pharmaceutical scientists on AI-driven analytical method optimization .
Domain SME: Key Responsibilities
- Protocol Development & Method Validation
- Design and review analytical protocols for pharmaceutical products.
- Validate methods in accordance with ICH, USP, EP, and other regulatory guidelines.
- Design and review analytical protocols for pharmaceutical products.
- Regulatory Compliance Validation
- Ensure adherence to global regulatory standards for analytical methods.
- Conduct compliance checks and maintain documentation for audits.
- Ensure adherence to global regulatory standards for analytical methods.
- Method Optimization & Logic Development
- Develop optimization logic for analytical methods to improve efficiency and accuracy.
- Implement risk-based approaches for method selection and validation.
- Develop optimization logic for analytical methods to improve efficiency and accuracy.
- Technical Leadership
- Act as a domain expert for cross-functional teams in R&D and Quality Assurance.
- Provide guidance on regulatory submissions and technical dossiers.
- Act as a domain expert for cross-functional teams in R&D and Quality Assurance.
- Knowledge Management
- Maintain up-to-date knowledge of pharmacopeial standards and regulatory changes.
- Train teams on best practices for compliance and method development.
- Maintain up-to-date knowledge of pharmacopeial standards and regulatory changes.
Required Skills & Qualifications
- Strong expertise in protocol generation, method validation, and regulatory compliance.
- In-depth knowledge of USP, EP, ICH guidelines, and global pharmacopeial standards.
- Experience in method optimization logic and analytical risk assessment.
- Excellent documentation and audit readiness skills.
- Strong communication and stakeholder management abilities.
Preferred Qualifications
- Hands-on experience with regulatory submissions and compliance audits.
- Familiarity with automation tools for method validation and optimization.
- Advanced degree in Pharmaceutical Sciences, Analytical Chemistry, or related field.