Sr. Manager, External Manufacturing

Vanda Pharmaceuticals, Inc.; Washington (District of Columbia); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Unlimited paid time off

Parental leave

401k matching program

Job summary

Vanda Pharmaceuticals, Inc. is seeking a skilled professional to manage external contract manufacturing organizations (CMOs) for commercial product manufacturing in Washington, DC. You will be responsible for ensuring the timely and quality delivery of products while managing complex supply chains in compliance with regulations.

The ideal candidate has a Bachelor’s degree in a related field and over 7 years of relevant experience. The position offers a competitive compensation package, including health benefits and a 401k matching program.

Qualifications

• 7+ years of experience in pharmaceutical manufacturing, technical operations, or CMC.
• Strong knowledge of cGMP regulations and commercial manufacturing operations.
• Proven ability to manage external CMOs for commercial drug product operations.

Responsibilities

• Ensure on-time, in-full (OTIF) delivery of commercial supply and meet inventory targets.
• Lead operational oversight of CMOs, including production performance.
• Provide technical oversight and ensure product quality across manufacturing processes.

Skills

Pharmaceutical manufacturing experience

Vendor management

Regulatory compliance

Cross-functional team management

Process validation

Education

Bachelor’s degree in Chemical Engineering, Pharmacy, Chemistry, or related discipline

Job description

Headquarters
Vanda Pharmaceuticals HQ
2200 Pennsylvania Avenue NW
Suite 300E
Washington, DC 20037, USA

• 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

External CMO Management & Governance

• 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.

Technical & CMC Leadership

• 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.

Quality & Compliance

• 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.

Cross-Functional Integration

• 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.

Regulatory Support

• Contribute to CMC sections of regulatory submissions (NDA/ANDA variations, annual reports, supplements).
• Ensure manufacturing processes and changes are aligned 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 and 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.
• Proven success managing complex supply chains in a matrixed environment.
• Strong ownership mindset for commercial supply reliability
• Excellent vendor and stakeholder management skills
• Ability to operate in a fast‑paced, matrixed environment
• Strategic thinking with strong execution discipline
• Effective problem‑solving and decision‑making under pressure

Must be able to perform the essential functions of the position, with or without reasonable accommodation; however, reasonable accommodations will be provided for qualified individuals with disabilities unless doing so would impose undue hardship.

The total compensation package for this position will also include incentive compensation and benefits such as health insurance, unlimited paid time off, parental leave, a 401k matching program, and other benefits to its employees.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation, protected veteran status, or any other characteristic protected by law.

If you reside in a state or locality with enacted pay transparency laws, you are entitled to request and receive additional details regarding compensation and benefits. For assistance, please contact us at 202-524-8238 between 8:00 AM and 5:30 PM ET, Monday through Friday.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.