Sr. Manager, External Manufacturing

Vanda Pharmaceuticals•Washington, DC

About The Position

This role serves as the single point of accountability for assigned Contract Manufacturing Organizations (CMOs) supporting commercial product manufacturing and packaging operations. The position ensures on-time, in-full (OTIF) delivery of commercial supply, meeting demand forecasts and inventory targets. It involves owning production planning alignment with Supply Chain, including capacity planning, campaign scheduling, and inventory optimization. The role also requires proactively identifying supply risks and leading mitigation strategies to ensure uninterrupted commercial supply. Additionally, it involves leading day-to-day operational oversight of CMOs, establishing and maintaining robust governance processes, driving vendor performance management, and partnering with Procurement on contracting and cost optimization. Technical and CMC leadership includes providing technical oversight of commercial manufacturing processes, supporting technology transfers, process validation, scale-up, and lifecycle management. It also involves leading investigations, root cause analyses, and championing process robustness. Quality and compliance are critical, ensuring adherence to cGMP, regulatory filings, and quality agreements, and collaborating with Quality Assurance on deviations and change controls. The role requires cross-functional integration with various departments and support for regulatory submissions and health authority inspections.

Requirements

Bachelor’s degree in Chemical Engineering, Pharmacy, Chemistry, or related discipline.
7+ years of experience in pharmaceutical manufacturing, technical operations, or CMC.
Demonstrated experience managing external CMOs for commercial drug product and/or packaging operations.
Strong knowledge of cGMP regulations, commercial manufacturing operations, and tech transfer and process validation.
Proven ability to manage cross-functional teams and external partners.

Nice To Haves

Advanced degree (MS, PhD, MBA).
Experience with commercial small-molecule products (solid oral dosage and/or sterile).
Experience supporting regulatory filings and health authority inspections.
Strong track record in commercial supply chain management and vendor governance.
Experience in lifecycle management and post-approval changes.
Proven success managing complex supply chains in a matrixed environment.

Responsibilities

Serve as the single point of accountability for assigned CMOs supporting commercial product manufacturing and packaging operations.
Ensure on-time, in-full (OTIF) delivery of commercial supply, meeting demand forecasts and inventory targets.
Own production planning alignment with Supply Chain, including capacity planning, campaign scheduling, and inventory optimization.
Proactively identify supply risks and lead mitigation strategies to ensure uninterrupted commercial supply.
Lead day-to-day operational oversight of CMOs, including production performance, issue resolution, and escalation management.
Establish and maintain robust governance processes (KPIs, business reviews, scorecards, and continuous improvement plans).
Drive vendor performance management, including quality, cost, delivery, and reliability metrics.
Partner with Procurement on contracting, scope definition, and cost optimization initiatives.
Provide technical oversight of commercial manufacturing processes, ensuring consistent product quality and performance.
Support and oversee technology transfers, process validation, scale-up, and lifecycle management at external sites.
Lead or contribute to complex investigations, root cause analyses, and implementation of CAPAs.
Champion process robustness and continuous improvement initiatives across CMOs.
Ensure all manufacturing activities comply with cGMP, regulatory filings, and quality agreements.
Collaborate closely with Quality Assurance on deviations, change controls, CAPAs, and audit readiness.
Support health authority inspections and ensure effective response to regulatory observations (if applicable).
Maintain compliance of technical documentation and manufacturing records.
Partner with Supply Chain, Quality, Regulatory, Technical Development, and Commercial teams to align manufacturing operations with business priorities.
Ensure seamless communication of manufacturing performance, risks, and supply outlook to leadership.
Support launch readiness and ongoing lifecycle management for commercial products.
Contribute to CMC sections of regulatory submissions (NDA/ANDA variations, annual reports, supplements).
Ensure manufacturing processes and changes are aligned with global regulatory requirements.