AI Leads - Clinical/Drug Substance/Drug Product with CDMO (Contract Development and Manufacturing Organization) Exp. (Remote)
We are currently looking for three AI Leads to drive AI innovation across key areas of a Life Sciences/Biopharma organization:
- AI Lead Clinical Trial (CT)
- AI Lead Drug Substance (DS)
- AI Lead Drug Product (DP)
These roles will act as forward deployed AI Leaders, responsible for identifying high impact opportunities and delivering scalable AI/GenAI solutions that improve business workflows, decision-making, and operational efficiency.
Role Summary (Applicable to All 3 Roles):
As an AI Lead, you will partner with business, data science, engineering, and IT teams to identify where AI can create measurable impact and deliver solutions from concept to production. You will work hands-on with AWS, Databricks, Dataiku, and OpenAI, while driving GenAI/ChatGPT adoption across enterprise workflows. You will balance immediate business outcomes with long-term scalable AI capabilities, ensuring alignment with enterprise data and AI strategies.
Key Responsibilities:
- Lead end-to-end delivery from use case identification, pilot and production deployment.
- Identify and prioritize high-value AI use cases within Clinical, Drug Substance, or Supply Chain domains.
- Build and deploy prototypes and MVPs using AI/ML and GenAI technologies.
- Collaborate with data science, engineering, and IT teams to integrate solutions into MES, LIMS, and enterprise data platforms.
- Assess data readiness, quality, and integration needs.
- Develop and own an AI roadmap with clear milestones and measurable impact.
- Drive user adoption and change management across business and manufacturing/process teams.
- Promote ChatGPT/GenAI adoption through playbooks, training, and real-world applications.
- Ensure solutions comply with GxP and regulatory requirements.
- Communicate effectively with stakeholders and senior leadership.
Domain Focus:
- AI Lead Clinical Trial (CT): Clinical trials, patient data, study optimization, clinical operations.
- AI Lead Drug Substance (DS): Manufacturing operations, process development, MSAT, investigations, technical data.
- AI Lead Drug Product (DP): Formulation development, batch performance, process control, quality consistency, deviation prediction, and GMP manufacturing efficiency across drug product manufacturing.
Required Skills & Qualifications:
- 10+ years of experience in either:
- Biopharma manufacturing, process development, MSAT OR
- AI/Data Science within Life Sciences.
- Proven experience delivering AI/ML solutions in regulated (GxP) environments.
- Experience in CDMO or biopharma manufacturing environments is a MUST.
- Strong understanding of:
- Machine learning and predictive analytics
- Generative AI (LLMs, RAG, workflow integration, guardrails)
- Cloud and data platforms (AWS, Azure, or Google Cloud Platform)
- Hands-on experience with Python and/or SQL.
- Familiarity with MES, LIMS, and manufacturing systems.
- Ability to drive outcomes in cross-functional and global environments.
- Knowledge of biologics processes (cell culture, purification).
- Experience with digital twins or advanced process optimization.
- Exposure to Agentic AI or autonomous systems.
- Strong stakeholder management and communication skills.
Other Job Details:
- Job Type: C2C or W2.
- Duration: 6 12 months with high possibility of extension.
- Location: Remote
- Interviews: Video interviews.
- Docs required: ID proof will be required.
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