Product Quality Director - Hybrid Modalities
Amgen
Summary
In this vital role you will be the champion for a product team as the Product Quality Leader (PQL), providing technical expertise, strategic and project leadership to the Product Quality (PQ) organization.
Job description
The PQL has responsibility for working with PQ staff and executive leadership, International Quality, Quality Control, Contract Manufacturing Quality, Regulatory, Process Development, Quality Assurance, and other functional areas on the resolution of issues associated with process/manufacturing, in process controls, analytical methods, specifications, comparability, stability, reference standards, importation testing, investigations, change control, regulatory submissions and inspections.
The PQL has responsibility for inspiring change to implement operationally efficient processes and corporate alignment across international sites.
As a leader in Product Quality, the successful candidate is expected to have experience, knowledge and understanding of large and small molecule development and commercial lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment, and Amgen Quality Management Systems.
This role is directly responsible for the product quality and related activities (e.g., comparability, specifications, stability, annual product review) in support of the Product Development Team (PDT).
The PQL provides scientific oversight for the product quality of pivotal and/or commercial product(s) including timely product data review, ownership of GMP documents and regulatory filing sections, execution of transactions in relevant GMP system, and support for regulatory audits and responses to questions.
The individual is directly responsible for leading a Product Quality Team (PQT), including oversight of the product stability programs, providing indirect staff management and guidance to members of the PQT.
Key Responsibilities include:
- Provide effective, cross-functional quality leadership, and manage multiple, complex long-term PDT deliverables for hybrid modality programs (such as ADCs), 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
Requirements
- Doctorate Degree & 4 years of Quality, Operations, Scientific, or Manufacturing experience OR Master's Degree & 7 years of Quality, Operations, Scientific, or Manufacturing experience OR Bachelor's Degree & 9 years of Quality, Operations, Scientific, or Manufacturing experience
- Advanced degree in chemistry, biochemistry, biology, or a related biotechnology sciences field
- Expertise in the areas of large and small molecule and bioconjugate development, analytical testing, and industry regulations
- 8+ years of pharmaceutical experience with increasing responsibility in quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment experience
- 6+ years working in a regulated environment (direct GMP)
- 4 years experience managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
- 2+ years experience as a technical expert or product champion
- 1+ years of experience with authoring or review of regulatory filing or similar regulatory documentation
- 1+ years of experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
- Experience in Project Management in support of product development
- Knowledge of protein and small molecule quality, compliance and regulatory requirements
- Knowledge of analytical techniques used for small molecule and protein product quality control
- Understanding of drug substance and drug product development and manufacturing
- Strong leadership and management skills
- General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals
- Previous experience working on a cross-functional team in a matrix environment
- Excellent written and verbal communication skills, including facilitation and presentation skills
Benefits
- Retirement and Savings Plan
- Medical, Dental & Vision
- Life and Disability Insurance
- Flexible Spending Accounts
- Discretionary Annual Bonus
- Stock-based Long-term Incentives
- Award-winning Time-off Plans
- Flexible Work Models
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.