End to End Lead, LSA

Key Accountabilities

• Lead the asset lifecycle from project completion through operational readiness, GMP startup, PPQ, ramp-up, commercial execution, and future expansion.
• Serve as the single point of operational accountability, aligning cross-functional priorities and resolving/escalating risks impacting safety, quality, delivery, cost, schedule, and customer outcomes.
• Own and execute the integrated asset readiness plan across Manufacturing, MSAT, Quality, QC, Engineering, Supply Chain, Program Management, EHS, Finance, HR, IT, and customer stakeholders.
• Establish and lead governance for readiness, including critical path management, risk mitigation, decision tracking, issue escalation, and transition to steady-state operations.
• Ensure effective handover from Global Engineering, including facility, equipment, utilities, automation, documentation, and qualification readiness for GMP operations.
• Drive execution readiness for water runs, engineering runs, GMP batches, PPQ, and commercial manufacturing through staffing, training, systems, materials, and scheduling.
• Lead asset strategy and support CAPEX expansion planning, including scaling from initial production to multi-line operations over a 3–5 year horizon.
• Partner with senior leadership to define expansion scope, business case, operating model, resourcing, risk, and execution strategy.
• Lead a senior cross-functional matrix team and asset organization, fostering a high-performance culture focused on safety, quality, accountability, and continuous improvement.
• Own asset performance, including GMP compliance and inspection readiness, production delivery, customer commitments, financial targets (cost, COGS, budget), and long-term talent development.

Key Requirements & Skills

• Proven ability to lead complex GMP startups, operational readiness programs, facility handovers, and commercial manufacturing ramp-up.
• Demonstrated executive presence, with experience presenting clear recommendations, risks, and investment rationale at senior leadership or Executive Committee level.
• Experience supporting CAPEX expansion, capacity scale-up, or strategic manufacturing growth initiatives.
• Strong ability to lead senior cross-functional matrix teams (AD/Director level) through influence, alignment, and accountability.
• Deep knowledge of GMP operations, including validation/PPQ, inspection readiness, deviation/CAPA, change control, and batch release.
• Strong ability to lead senior cross-functional matrix teams (AD/Director level) through influence, alignment, and accountability.
• Expertise in governance and execution discipline, including critical path management, risk mitigation, escalation, and decision tracking.
• Strong understanding of GMP systems and operational infrastructure (ERP, MES/eBR, QMS, training systems, scheduling, and master data).
• Exceptional communication skills, with the ability to translate complex technical, operational, and financial concepts into clear decisions and trade-offs.
• Strong business acumen, including linking strategy, capacity, capital investment, COGS, and customer commitments into executable plans.
• High agility and leadership effectiveness, with the ability to operate in ambiguity, drive change, build high-performing teams, and deliver results through collaboration and structured execution.