Senior Manager, Development & Manufacturing

Overview

• Provide strategic and operational leadership within Amgen Contract Development and Manufacturing (ACDM)
• Drive execution of external development and manufacturing activities for Synthetic Drug Substance (DS) programs supporting Antibody Drug Conjugate (ADC) and Small Molecule modalities across clinical and commercial stages.
• Lead complex, cross‑functional programs with external development and manufacturing partners (CDMOs/CROs) to ensure reliable, compliant, and efficient supply execution.
• Influence internal and external stakeholders in a dynamic global environment.
• Serve as the primary interface with CDMOs/CROs and internal cross‑functional teams.
• Drive sourcing activities including supplier selection, onboarding, scope of work development, and proposal management.
• Oversee manufacturing operations, technical transfers, compliance, and issue resolution with external partners.
• Ensure project delivery against quality, compliance, supply, timeline, and cost objectives.
• Lead risk management, escalation resolution, and operational decision‑making across programs.
• Build strong internal and external partnerships to support program success and operational excellence.
• Manage quality systems activities including deviations, investigations, change controls, and CAPAs.
• Manage budgets, purchase orders, and financial forecasting for external manufacturing activities.
• Mentor and train ACDM staff and cross‑functional teams and demonstrate strong leadership, collaboration, and accountability.

• Doctorate degree and 2 years of Manufacturing, Operations, Process Development, or External Supply experience OR Master’s degree and 4 years of Manufacturing, Operations, Process Development, or External Supply experience OR Bachelor’s degree and 6 years of Manufacturing, Operations, Process Development, or External Supply experience OR Associate’s degree and 10 years of Manufacturing, Operations, Process Development, or External Supply experience OR High school diploma / GED and 12 years of Manufacturing, Operations, Process Development, or External Supply experience
• Advanced degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field preferred.
• 10+ years of pharmaceutical or biotechnology experience in Synthetic DS development and manufacturing.
• Experience supporting Small Molecule and/or ADC modalities from development through commercial manufacturing.
• Proven leadership of external manufacturing programs with CDMOs/CROs in a cGMP environment.
• Strong knowledge of cGMPs, quality systems, regulatory/CMC requirements, and pharmaceutical operations.
• Experience with sourcing strategies, supplier management, and commercial supply operations.
• Strong project management, strategic thinking, and problem‑solving skills.
• Experience managing deviations, investigations, change controls, and CAPAs with external partners.
• Demonstrated ability to lead and influence cross‑functional, matrixed teams.
• Strong communication, collaboration, negotiation, and stakeholder management skills.
• Self‑starter who thrives in fast‑paced, complex environments and drives continuous improvement.
• Demonstrated commitment to teamwork, accountability, innovation, and patient focus.