layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Senior Director, External Manufacturing at Syndax Pharmaceuticals

Own the operating relationship with contract development and manufacturing organizations (CDMOs), including governance, business reviews, performance management, issue escalation, and executive engagement.
Provide ongoing day-to-day operational oversight of external drug substance and drug product manufacturing for all clinical and commercial programs.
Lead identification, evaluation, selection, onboarding, and business integration of manufacturing partners in collaboration with CMC technical, Quality, Supply Chain, Regulatory, and Finance functions.
Partner with Drug Substance, Drug Product, and Analytical technical leads to ensure successful process development, technology transfer, validation, and continued process verification.
Drive CDMO contract development and manufacturing organization readiness, coordination, commitment, and performance across the network.
Partner with Quality to ensure manufacturing operations are performed in accordance with cGMP requirements.
Monitor manufacturing plans and campaigns for schedule adherence, capacity, yield, cost, and supply performance, and drive timely resolution of operational risks.
Establish clear performance measures and accountability for quality, delivery, technical execution, cost, service, and continuous improvement.
Coordinate across Supply Chain and technical teams to align production plans, materials, capacity, inventory, and business continuity strategies.
Identify and mitigate external manufacturing risks through alternate sourcing, capacity planning, scenario planning, and supplier improvement plans.
Support regulatory filings, inspections, agency responses, commercial launches, and lifecycle activities by ensuring manufacturing partner readiness and execution.
Support CDMO contract negotiations and development of budgets, forecasts, long-range network plans, and continuous improvement goals.
Communicate manufacturing performance, risks, decisions, and recovery plans clearly to senior leadership and cross-functional teams.
Build and develop a high-performing external manufacturing team as organizational needs grow.
Represent the broader CMC/Pharmaceutical Development & Manufacturing Organization on cross functional program/asset teams as required.
Travel internationally and domestically to manufacturing sites, suppliers, partners, and company offices as required.
Desired Experience/Education and Personal Attributes: Bachelor’s degree in chemistry, chemical engineering, biochemistry, pharmaceutical sciences, or a related discipline required; advanced technical degree and/or MBA preferred.
15+ years of progressive pharmaceutical or biotechnology manufacturing experience, including substantial leadership of outsourced manufacturing and global external partners. Executive Director candidates should demonstrate broader network strategy, organizational leadership, and commercial accountability.
Deep experience with small molecule API and oral solid dose manufacturing is required.
Experience with biologics drug substance and sterile drug product fill and finish is strongly preferred.
Experience launching new commercial products in the U.S. and international markets.
Experience managing multiple international CDMOs across multiple regions and time zones is required.
Demonstrated success managing external partner governance and driving operating performance improvements.
Experience supporting technology transfer, process validation, continued process verification, regulatory filings, commercial launch, and ongoing commercial supply.
Strong understanding of global good manufacturing practice requirements, quality systems, and inspection readiness, with the ability to work effectively within clear technical and Quality accountabilities.
Sound technical and operational judgment, with experience resolving complex manufacturing and supply issues through cross-functional leadership.
Ability to integrate manufacturing execution with supply, quality, regulatory, financial, and program priorities.
Excellent leadership, communication, executive presence, and cross-functional influence in a fast-paced, matrixed, and geographically dispersed organization.
Strategic and pragmatic leader who drives execution, makes timely decisions, and holds internal and external teams accountable.
Ability to lead highly capable and technical site management teams through complex situations in a time constrained environment with confidence and poise to ensure successful outcomes for patients and for the business.
Location
: Syndax’s corporate office is in New York, NY.

Senior Director, External Manufacturing

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