Associate Director, Early In-Process Analytics, Biotherapeutics Process Development, Pharmaceutical Sciences
Core
Lead the Early In-Process Analytics function to support process development, pilot operations, and GMP manufacturing activities through in-process analytical testing.
Role type
Associate Director, Early In-Process Analytics (Biotherapeutics)
Builds
In-process analytical methods, testing plans, and data-driven decisions for biologics drug substance development and manufacturing.
Domain
Biopharmaceuticals / Biotherapeutics Process Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
in-process analytical methods, chromatography, mass spectrometry, spectroscopy, method transfer, qualification, verification, validation, GMP compliance, data integrity, chain-of-custody, team leadership, cross-functional collaboration, automation and digitalization integration
Preferred skills
PhD in relevant field, significant industry experience in biologics process development and analytical sciences
Technologies
chromatography, mass spectrometry, spectroscopy, laboratory automation systems, data management systems
Responsibilities
Define strategy, standards, and testing plans for process development and GMP sample testing; manage method transfer and implementation from Analytical Development; oversee method qualification, verification, and validation activities; collaborate with Global IPA to align analytical methods and workflows; design and execute analytical experiments to support process characterization and scale-up; ensure data integrity and maintain sample chain-of-custody; lead and develop a multidisciplinary laboratory team; work with automation and digitalization colleagues to support equipment and system commissioning; drive continuous improvement in IPA workflows and data management practices
Seniority
Senior, hands-on IC with leadership responsibilities
