Sr. Manager, External Manufacturing
Vanda Pharmaceuticals
June 27, 2026
Remote friendly (Washington, DC)
United States
Operations
Key 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 governance processes (KPIs, business reviews, scorecards, continuous improvement plans).
- Drive vendor performance management (quality, cost, delivery, reliability metrics).
- Partner with Procurement on contracting, scope definition, and cost optimization.
- Provide technical oversight of commercial manufacturing processes to ensure consistent product quality and performance.
- Support technology transfers, process validation, scale-up, and lifecycle management at external sites.
- Lead or contribute to investigations, root cause analyses, and CAPAs.
- Ensure manufacturing activities comply with cGMP, regulatory filings, and quality agreements; collaborate on deviations, change controls, CAPAs, and audit readiness.
- Support health authority inspections and responses to regulatory observations (if applicable).
- Maintain compliance of technical documentation and manufacturing records.
- Partner cross-functionally (Supply Chain, Quality, Regulatory, Technical Development, Commercial) and communicate manufacturing performance, risks, and supply outlook.
- Contribute to CMC sections of regulatory submissions (NDA/ANDA variations, annual reports, supplements) and align processes/changes with global regulatory requirements.
Position Requirements
Minimum Qualifications
- 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/process validation.
- Proven ability to manage cross-functional teams and external partners.
Preferred Qualifications
- 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.
- Success managing complex supply chains in a matrixed environment.
Key Competencies
- Ownership mindset for commercial supply reliability; excellent vendor/stakeholder management.
- Ability to operate in a fast-paced, matrixed environment.
- Strategic thinking with strong execution; problem-solving/decision-making under pressure.
Benefits (explicitly listed)
- Incentive compensation; health insurance, unlimited paid time off, parental leave, and 401k matching.
Application Instructions
- For assistance, contact 202-524-8238 between 8:00 AM and 5:30 PM ET, Monday through Friday.
- 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 governance processes (KPIs, business reviews, scorecards, continuous improvement plans).
- Drive vendor performance management (quality, cost, delivery, reliability metrics).
- Partner with Procurement on contracting, scope definition, and cost optimization.
- Provide technical oversight of commercial manufacturing processes to ensure consistent product quality and performance.
- Support technology transfers, process validation, scale-up, and lifecycle management at external sites.
- Lead or contribute to investigations, root cause analyses, and CAPAs.
- Ensure manufacturing activities comply with cGMP, regulatory filings, and quality agreements; collaborate on deviations, change controls, CAPAs, and audit readiness.
- Support health authority inspections and responses to regulatory observations (if applicable).
- Maintain compliance of technical documentation and manufacturing records.
- Partner cross-functionally (Supply Chain, Quality, Regulatory, Technical Development, Commercial) and communicate manufacturing performance, risks, and supply outlook.
- Contribute to CMC sections of regulatory submissions (NDA/ANDA variations, annual reports, supplements) and align processes/changes with global regulatory requirements.
Position Requirements
Minimum Qualifications
- 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/process validation.
- Proven ability to manage cross-functional teams and external partners.
Preferred Qualifications
- 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.
- Success managing complex supply chains in a matrixed environment.
Key Competencies
- Ownership mindset for commercial supply reliability; excellent vendor/stakeholder management.
- Ability to operate in a fast-paced, matrixed environment.
- Strategic thinking with strong execution; problem-solving/decision-making under pressure.
Benefits (explicitly listed)
- Incentive compensation; health insurance, unlimited paid time off, parental leave, and 401k matching.
Application Instructions
- For assistance, contact 202-524-8238 between 8:00 AM and 5:30 PM ET, Monday through Friday.