Associate Director, Process Development Lead, Tech Ops
Core
Leading global process development teams to develop, optimize, and implement scalable manufacturing processes for plasma-derived biotherapeutics from pre-clinical through commercial launch.
Role type
Senior leadership process development lead (plasma-derived biologics)
Builds
Robust, scalable manufacturing processes for plasma-derived biotherapeutics
Domain
Biotechnology / Pharmaceutical manufacturing (plasma-derived biotherapeutics)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Postgraduate degree (preferably PhD) in Life Sciences or Engineering, 10+ years in process development/manufacturing, team leadership, cross-functional program management, drug substance process development for biologics, scale-up and technology transfer, regulatory submissions, GMP compliance, strategic planning, change management
Preferred skills
Experience in multicultural international environments, advanced manufacturing and digital approaches adoption
Technologies
Plasma fractionation, recombinant protein technology, cell and gene therapy platforms
Responsibilities
Develop and execute short- to mid-term strategies for drug substance process development, provide technical leadership for process development from pre-clinical to launch, lead process development for major manufacturing changes, drive assessment and implementation of innovative technologies, promote Quality by Design (QbD) approach, act as change agent for new ways of working, lead process development execution and alignment with project governance, prepare and approve technical documentation and regulatory submissions, collaborate with Process Engineering and Manufacturing for scale-up and tech transfer, oversee transfer of processes to commercial manufacturing, engage with external partners to optimize capabilities, lead and manage team for resource planning and staff allocation, drive talent development and succession planning, foster high-performance culture, ensure execution alignment with timelines and quality standards, drive continuous improvement of processes and tools, ensure compliance with GMP and regulatory expectations
Seniority
Senior, hands-on IC with leadership responsibilities
