Associate Director, Drug Substance Manufacturing & CMO

ACADIA Pharmaceuticals Inc.; Baar; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

Acadia Pharmaceuticals Inc. seeks an senior professional to oversee commercial contract manufacturing organizations (CMOs) and other third-party suppliers, ensuring supply and quality targets are met.

You will transfer processes from R&D to commercial suppliers, manage schedules and drive profitability with a strong focus on GMP compliance. The role requires a minimum of 10 years in pharma/biotech, with 6 years in leadership, and significant travel to global sites.

Qualifikationen

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

Aufgaben

• Oversight of CMOs for commercial manufacturing and transfer from R&D to suppliers.
• Negotiate and manage CMO contracts and performance metrics.
• Develop SOPs and processes for Commercial Manufacturing.
• Collaborate with Quality Assurance to ensure GMP compliance.
• Coordinate with Regulatory Affairs for filings and inspections.
• Provide on-site process coverage and mentorship to staff.
• Identify and select CMOs for manufacture of commercial products.
• Track deviations and assess regulatory impact with teams.

Kenntnisse

Contract mgmt

Leadership

Biopharma knowledge

Regulatory understanding

Travel readiness

Ausbildung

BS in Engineering/Chemistry or equivalent

Master's or Ph.D. preferred

Jobbeschreibung

Acadia Pharmaceuticals Inc. seeks an senior professional to oversee commercial contract manufacturing organizations (CMOs) and other third-party suppliers, ensuring supply and quality targets are met.

You will transfer processes from R&D to commercial suppliers, manage schedules and drive profitability with a strong focus on GMP compliance. The role requires a minimum of 10 years in pharma/biotech, with 6 years in leadership, and significant travel to global sites.