Product Quality Director - Synthetics

Role Summary

Product Quality Director - Synthetics leads the Product Quality Team, providing technical expertise and strategic leadership to the Product Quality (PQ) organization. The role collaborates with PQ staff, executive leadership, International Quality, Quality Control, Contract Manufacturing Quality, Regulatory, Process Development, Quality Assurance, and other functions to resolve issues related to process/manufacturing, in-process controls, analytical methods, specifications, reference standards, import testing, investigations, change control, regulatory submissions, and inspections.

The position drives operationally efficient processes and corporate alignment across international sites and requires experience with small molecule, peptide, or oligonucleotide development and lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment, and Amgen Quality Management Systems.

• Provide effective, cross-functional quality leadership, and manage multiple, complex long-term PDT deliverables for late phase and commercial programs, including actions required for the PQT/APR; specification, comparability, and stability programs; site and method transfers; product quality impact statements for NCs; and PQ owned regulatory filing sections and RTQs
• Provide expertise in science and risk-based evaluation of complex processes and product quality data, including ability to develop patient-oriented strategies that account for business needs and/or provide novel solutions to complex issues
• Demonstrate proficiency in oral and written communication of complex information to Amgen leadership, peers and regulatory agencies including communications associated with inspectional activities
• Demonstrate proficiency in knowledge of cGMP and international regulatory expectations
• Understand and respond to the impact of emerging scientific/technical trends and their implications for Amgen
• Actively mentor new and existing team members to develop Product Quality core skills

• Required:
  
  Bachelor's Degree and 9 years of Quality, Operations, Scientific, or Manufacturing experience
• Required:
  
  Master's Degree and 7 years of Quality, Operations, Scientific, or Manufacturing experience
• Required:
  
  Doctorate Degree and 4 years of Quality, Operations, Scientific, or Manufacturing experience
• Preferred:
  Advanced degree in chemistry, biochemistry, biology, or a related biotechnology sciences field
• Preferred:
  Expertise in drug substance and drug product manufacturing, analytical testing, and regulations for small molecules, peptides, and/or oligonucleotides
• Preferred: 8+ years of pharmaceutical experience with increasing responsibility in quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing
• Preferred: 6+ years working in a regulated environment (direct GMP)
• Preferred: 4 years managing people and/or leadership experience leading teams, projects, programs, or resource allocation
• Preferred: 2+ years as a technical expert or product champion
• Preferred: 1+ years of experience with authoring or reviewing regulatory filing or similar regulatory documentation
• Preferred: 1+ years of experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
• Preferred:
  Experience in Project Management supporting product development
• Preferred:
  Knowledge of quality, compliance and regulatory requirements
• Preferred:
  Knowledge of analytical techniques used for synthetic product quality control
• Preferred:
  Understanding of drug substance and drug product development and manufacturing
• Preferred:
  Strong leadership and management skills
• Preferred:
  General knowledge of cGMP and filing regulations, practices, and trends for pharmaceuticals
• Preferred:
  Cross-functional, matrix-environment experience
• Preferred:
  Excellent written and verbal communication skills, including facilitation and presentation skills

• Bachelor's Degree or higher in a related field; advanced degrees preferred (e.g., Master's, Doctorate)