Associate Director, Drug Substance Manufacturing & CMO Ops

Arbeitnow; Zug; Vor Ort; CHF 149.000 - 199.000; Vollzeit

Benefits dieser Stelle

Competitive base & bonus

Medical, dental, and vision insurance

Employer-paid life, disability, travel

401(k) with 1:1 match up to 5%

Employee Stock Purchase Plan

15+ vacation days

Paid holidays

Paid sick time

Paid parental leave

Tuition assistance

Zusammenfassung

Acadia Pharmaceuticals is seeking a senior manager to oversee commercial contract manufacturers and third-party suppliers, ensuring smooth transfer from R&D to commercial production while meeting quality, budget, and profitability goals.

You will negotiate CMO contracts, develop SOPs, lead performance metrics, and collaborate with Quality Assurance and Regulatory Affairs to support filings and GMP compliance. Occasional travel to global sites is required.

Qualifikationen

• Minimum 10 years in the pharmaceutical/biotechnology industry with at least 6 years in a leadership role.
• Contract service provider experience and strong CMO management.
• Understanding of biopharmaceutical drug development, regulatory filings, and quality inspections/audits.
• Extensive knowledge of post-approval manufacturing changes and related regulations.
• Willingness to travel frequently to EU and Asia manufacturing sites.

Aufgaben

• Oversee CMOs and third-party suppliers; manage transfer from R&D to commercial production.
• Negotiate and manage CMO contracts.
• Develop SOPs and processes for Commercial Manufacturing.
• Diagnose and resolve process issues with CMOs.
• Identify, evaluate, and select CMOs for commercial manufacture.
• Develop metrics to measure CMO performance and lead partnership teams.
• Ensure GMP compliance with Quality Assurance and Regulatory Affairs.
• Support product filings and regulatory inspections.

Kenntnisse

Leadership experience

CMO oversight

Regulatory filings knowledge

Process development understanding

Quality inspections & audits

Ausbildung

Bachelor's degree in Engineering or Chemistry

Master's or PhD preferred

Tools

SOP development

Jobbeschreibung

Acadia Pharmaceuticals is seeking a senior manager to oversee commercial contract manufacturers and third-party suppliers, ensuring smooth transfer from R&D to commercial production while meeting quality, budget, and profitability goals.

You will negotiate CMO contracts, develop SOPs, lead performance metrics, and collaborate with Quality Assurance and Regulatory Affairs to support filings and GMP compliance. Occasional travel to global sites is required.