Associate Director, Global Contract Manufacturing

Acadia Pharmaceuticals; Zug; Vor Ort; CHF 180.000 - 260.000; Vollzeit

Benefits dieser Stelle

Competitive pay

Bonus program

Equity packages

Medical insurance

Life and disability coverage

401(k) Plan with company match

Employee stock purchase plan

Vacation days

Public holidays

Parental leave

Tuition assistance

Zusammenfassung

Acadia Pharmaceuticals seeks an experienced leader to oversee commercial contract manufacturing organizations and third-party suppliers. You will manage transfer of processes from R&D to commercial supply, maintain schedules, and protect process quality, budget, and profitability across global sites.

The role requires deep GMP knowledge, vendor management, and collaboration with QA and Regulatory Affairs to support filings and inspections.

Qualifikationen

• Contract service provider experience.
• Understanding of biopharmaceutical development, regulatory filings and audits.
• Extensive knowledge of post-approval manufacturing regulations and site changes.
• Frequent travel to global manufacturing sites, EU and Asia.

Aufgaben

• Oversee CMOs and third-party suppliers for development and commercial supply.
• Negotiate and manage CMO contracts and SOPs for Commercial Manufacturing.
• Diagnose process issues with CMOs and drive corrective actions.
• Identify and select CMOs for manufacture of commercial products.
• Develop metrics to measure CMO performance and lead partnership teams.
• Ensure GMP compliance and impact assessment with QA and regulatory teams.
• Develop timelines, goals, and deliverables for API manufacturing processes.
• Optimize processes to improve quality, portability, robustness, and costs.
• Support drug substance sourcing strategies and regulatory filings.
• Assist in site preparation for regulatory inspections and provide on-site coverage.

Kenntnisse

Contract manufacturing

CMO management

Regulatory knowledge

Process optimization

Ausbildung

BS in Engineering/Chemistry

Master's or Ph.D. preferred

Jobbeschreibung

Acadia Pharmaceuticals seeks an experienced leader to oversee commercial contract manufacturing organizations and third-party suppliers. You will manage transfer of processes from R&D to commercial supply, maintain schedules, and protect process quality, budget, and profitability across global sites.

The role requires deep GMP knowledge, vendor management, and collaboration with QA and Regulatory Affairs to support filings and inspections.