Director, Commercial Supply Chain
NewAmsterdam Pharma Corporation · Pennsylvania, United States · 4 wk ago
RemoteRemoteQuality AssuranceFull-time
Key Responsibilities
- Drive commercial supply chain readiness for the company’s first US product launch, including launch planning, launch cutover, operational readiness, and post-launch stabilization.
- Develop and maintain an integrated commercial supply chain launch plan aligned with regulatory approval timelines, manufacturing release, quality disposition, channel readiness, and customer availability requirements.
- Translate board-approved commercial plans into executable launch demand scenarios, supply volume assumptions, inventory strategies, and operational readiness actions.
- Identify launch-critical risks, dependencies, decision points, and mitigation plans across supply planning, distribution, trade, quality, finance, legal, compliance, regulatory, and commercial operations.
- Lead development of commercial supply planning processes for demand translation, supply allocation, inventory targets, safety stock, replenishment, expiry management, and launch demand scenarios.
- Translate commercial demand plans into supply requirements, forecasts, purchase orders and inventory plans in accordance with applicable supply agreements and contractual obligations.
- Develop inventory strategies that balance patient access, launch uncertainty, working capital, shelf life, and supply continuity.
- Monitor performance against supply plans and implement corrective actions to address forecast changes, production constraints, distribution disruptions, or demand variability.
- Partner with Market Access, Trade, Finance, Legal, Compliance, and Commercial Operations to support channel strategy, distribution model designs, order-to-cash readiness, and customer experience requirements.
- Ensure distribution and logistics capabilities are scalable, compliant, and aligned with launch requirements and future portfolio needs.
- Partner with Quality, Regulatory, Legal, and Compliance to ensure commercial supply chain processes comply with applicable regulations, internal policies, and product quality requirements.
- Support serialization, track-and-trace, lot traceability, product security, returns verification, and applicable DSCSA-related readiness activities for US commercialization.
- Define business requirements for commercial supply chain systems, master data, reporting, partner integrations.
- Support creation, review, and implementation of standard operating procedures, work instructions, training materials, and controlled processes required for commercial operations.
- Own day-to-day operational management and governance of key external supply chain partners, including 3PL, logistics providers, packaging or labeling partners, and other commercial operations vendors as applicable.
- Lead issue resolution across external partners and internal stakeholders to protect patient access, supply continuity, and launch timelines.
- Support contract input, budget planning, purchase order oversight, invoice review, and operational forecasting for commercial supply chain vendors.
- Monitor partner performance against contractual obligations, supply agreements, service levels, forecasts, and launch readiness expectations.
Qualifications
- Bachelor’s degree in supply chain, operations, life sciences, engineering, business, or a related field required; advanced degree preferred.
- 10+ years of experience in pharmaceutical, biotechnology, or life sciences supply chain, operations, logistics, manufacturing, or commercial operations.
- Direct experience supporting at least one pharmaceutical or biotech product launch in the United States strongly preferred.
- Experience managing 3PL, distribution, logistics, specialty pharmacy, specialty distribution, or other commercial supply chain partners.
- Strong understanding of GMP/GDP expectations, pharmaceutical distribution requirements, serialization, lot traceability, temperature-controlled logistics, and controlled commercial processes.
- Experience building supply chain processes, operating models, vendor governance, launch readiness plans, and cross-functional ways of working in a growing organization.
- Demonstrated ability to lead launch-critical workstreams with a high degree of ownership while partnering closely with senior functional leadership.
- Strong analytical, project management, communication, and executive-ready presentation skills.
- Comfort operating in an entrepreneurial, pre-commercial environment where processes, systems, and teams are still being built.
- Experience anticipating launch risks proactively and driving clear ownership of mitigation actions.
- Experience with ERP, planning tools, order management, serialization systems, partner integrations, and/or launch readiness dashboards.
- Experience developing S&OP or integrated business planning processes in a pre-commercial or early commercial biotech setting preferred.