AI Lead - 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
- AI Lead – Drug Substance (DS)
- AI Lead – Drug Product
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 Drug Product 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: 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: Formulation & fill-finish operations, drug product manufacturing, process optimization, technology transfer, MSAT support, batch release & deviations, quality/compliance (GMP), and manufacturing data analytics.
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 GCP)
- 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.
