AI Lead - Clinical/Drug Substance/Drug Product with CDMO (Contract Development and Manufacturing Organization) Exp. - Remote

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.