The End-to-End Lead, LSA is a critical leadership role responsible for delivering the SPM asset across its full lifecycle-from final capital project execution through operational readiness, GMP startup, PPQ, ramp-up, and sustained commercial operations. Acting as the single point of accountability, this leader brings together cross-functional teams across Manufacturing, MSAT, Quality, Engineering, Supply Chain, and beyond to ensure safe, compliant, reliable, and financially robust performance. In the near term, the role will lead the transition from project to operations, orchestrating flawless facility handover and readiness to enable water runs, engineering runs, GMP execution, and commercial launch.
This role also plays a key part in shaping the asset's future-leading strategy and execution for multi-year capacity expansion and scaling operations. Success requires the ability to influence at all levels, from Executive Committee discussions on investment and risk to day-to-day operational execution, while leading a high-performing, matrixed organization to deliver life-changing therapies to patients.
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.
- 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.
