M&S - IFB BMU Team Lead Buffer and Media Preparation
Core
Lead the design, planning, construction, start-up, and operation of buffer and media preparation systems for a new state-of-the-art insulin biologics facility in Beijing, China.
Role type
Senior Team Lead, Biologics Manufacturing (Buffer & Media)
Builds
Fully automated insulin manufacturing facilities
Domain
Biopharmaceuticals / Insulin Manufacturing / Biologics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Large-scale chemical/biochemical equipment operation, cGMP and regulatory compliance, Project engineering (P&ID, HAZOP), Vendor selection and procurement, SOP development, Commissioning (C&Q/OQ/PQ/PPQ), Process control strategy implementation, Microbial and contamination control, Filter and single-use concepts, Workforce planning
Preferred skills
Team leadership and upskilling, Talent management, Knowledge transfer, Cross-functional collaboration, Strategic workforce planning
Technologies
Single-use systems, Large-volume fermentation, Purification systems
Responsibilities
Review and approve equipment and system designs, Support vendor selection and equipment procurement, Develop standard operating procedures (SOPs) and operational documentation, Participate in equipment and system commissioning, Establish user requirements relevant for the process, Involved in C&Q/OQ/PQ/PPQ, Build the buffer & media preparation operational team
Seniority
Senior, hands-on IC with team leadership
