Head of Global Product Supply

Head of Global Product Supply

Responsibilities

• Design, develop, and implement transition from clinical-stage supply to a fully externalized, globally enabled manufacturing and supply team; maintain agile capability while scaling with a vendor network.
• Oversee externalized manufacturing and supply chain for ersodetug: submissions, approvals, launches, and global supply.
• Own Plan of Record for late-phase clinical supply supporting two Phase 3 pivotal global studies.
• Provide oversight and leadership to meet program milestones; ensure drug substance, drug product, and finished drug product manufacturing and supply.
• Continuously improve manufacturing and supply reliability; rebuild clinical supply chain via resourcing, SOP/process deployment, and daily execution monitoring.
• Accountable for all externalized manufacturing, shipping, distribution, labeling, packaging, and storage; ensure Right First Time, On Time In Full.
• Develop global ERSODETUG supply strategy/tactics for multiple indications; identify/mitigate supply risks.
• Maintain robust manufacturing, inventory management, and supply systems; lead resolution of deviations/investigations with Quality/MSAT.
• Partner to establish and sustain S&OP (supply/demand models, COGs, spend).
• Build/lead team and support functions; support Quality on registrational compliance and drug release.
• Oversee specifications alignment, manufacturing/scale-up problem solving, vendor/contract relationships, and negotiation of manufacturing agreements.

Qualifications

• B.S. required.
• Commercial launch experience required; biologics experience required.
• 20+ years progressive manufacturing and supply chain leadership (biotech/start-up preferred); rare disease preferred.
• Track record building global commercial product supply chain with successful regulator interactions.
• Strong leadership by influence, agility, problem solving, and communication; humility and sense of humor.
• May require evening/weekend coverage and travel up to 50%.

Benefits

• Health Insurance (Medical/Dental/Vision); Disability, Life & Long-Term Care; Holiday Pay; Tracking Free Vacation Program; 401(k) match; Educational Assistance; Fitness Center Reimbursement.