Product Quality Director - Hybrid Modalities

About the role

Amgen is looking for a Product Quality Director (Product Quality Leader, PQL) for its hybrid modality programs, such as ADCs. The PQL acts as the champion for a product team, providing technical expertise and strategic and project leadership to the Product Quality organization. The role is directly responsible for product quality and related activities (comparability, specifications, stability, annual product review) in support of the Product Development Team, and leads a Product Quality Team.

Key responsibilities

• Work with PQ staff, executive leadership, International Quality, Quality Control, Contract Manufacturing Quality, Regulatory, Process Development, Quality Assurance and other functions on issues around process/manufacturing, in-process controls, analytical methods, specifications, comparability, stability, reference standards, importation testing, investigations, change control, regulatory submissions and inspections.
• Drive operational efficiency and corporate alignment across international sites.
• Lead the product quality of pivotal and/or commercial products, including timely data review, ownership of GMP documents and regulatory filing sections, execution of transactions in the GMP system, and support for regulatory audits and responses to questions.
• Manage long-term PDT deliverables for hybrid modality programs, including specification, comparability and stability programs, site and method transfers, product quality impact statements for NCs, and regulatory filing sections and RTQs.
• Evaluate complex processes and product quality data using a risk-based approach, and communicate complex information clearly to leadership, peers and regulatory agencies, including during inspections.
• Mentor new and existing team members to develop Product Quality core skills.

Required profile

• Basic: doctorate with 4 years, master's with 7 years, or bachelor's with 9 years of quality, operations, scientific or manufacturing experience.
• Preferred: advanced degree in chemistry, biochemistry, biology or a related biotechnology field; 8+ years of pharmaceutical experience; 6+ years in a regulated, direct GMP environment; 4+ years managing people or leading teams/projects; 2+ years as a technical expert or product champion; 1+ year with regulatory filings and 1+ year supporting non-conformance investigations.
• Project management experience in product development and strong leadership and communication skills.

Required skills

• Knowledge of cGMP and international regulatory expectations
• Large and small molecule and bioconjugate development, analytical testing and industry regulations
• Drug substance and drug product development and manufacturing
• Analytical techniques for small molecule and protein quality control

What we offer

• Annual salary range posted for the U.S. (excluding Puerto Rico), with actual pay depending on skills, experience and qualifications.
• Health, dental and vision coverage, life and disability insurance, retirement savings plan with company contributions, and a discretionary annual bonus or sales-based incentive plan.
• Stock-based long-term incentives, flexible work models including remote and hybrid work where possible, and time-off plans.