Senior Pharmaceutical Process Expert; CMC​/Manufacturing Strategy

Senior Pharmaceutical Process Expert (CMC/Manufacturing Strategy)

We are hiring a Senior Process Engineer with deep experience in pharmaceutical manufacturing to help us build the next generation of process intelligence for GMP environments.

This role is not a traditional operations position. You will define what data is realistically accessible inside pharmaceutical plants
, how it should be interpreted, and how it can be used to deliver accurate, compliant, and actionable insights
—without disrupting validated systems.

You will play a key role in shaping a platform that learns golden batch behavior
, identifies process drift, and supports yield, quality, and energy optimization across pharmaceutical manufacturing.

• Define which process, equipment, batch, and quality data can be accessed in GMP pharmaceutical environments (without impacting validation or regulatory filings)
• Translate pharmaceutical manufacturing reality into robust process metrics (golden batch, CPPs, CQAs, deviations, drift, variability)
• Help design and validate ML-driven models that learn from historical and live batch data
• Guide the development of physics-informed and data-driven approaches for batch comparison and process stability
• Work closely with software and data teams to ensure models reflect real plant behavior, not theoretical assumptions
• Ensure all system design aligns with GMP, data integrity, and regulatory expectations (FDA, EMA)

• 8+ years of experience in pharmaceutical manufacturing or biotech (drug product)
• Strong background in process development, MSAT, tech transfer, or GMP manufacturing
• Deep understanding of batch processes, validation constraints, and change management
• Experience working with manufacturing data (batch records, historians, process analytics, SPC, DoE)
• Ability to bridge process engineering and data/ML teams
• Comfortable operating in regulated environments where compliance is non‑negotiable

You will directly influence how pharmaceutical manufacturers safely adopt advanced analytics. Your expertise will define what "good" looks like for pharma process intelligence.

Mid‑Senior level

Contract

Consulting and Strategy/Planning

Pharmaceutical Manufacturing and Business Consulting and Services