Product Quality Director - Hybrid Modalities

Career Category Quality Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Product Quality Director - Hybrid Modalities What you will do Let’s do this. Let’s change the world. In this vital role you will be the champion for a product team as the Product Quality Leader (referred to as PQL), providing technical expertise, strategic and project leadership to the Product Quality (PQ) organization. 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. Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies we’re employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients. 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 What we expect of you Basic Qualifications: Doctorate Degree & 4 years of Quality, Operations, Scientific, or Manufacturing experience Master's Degree & 7 years of Quality, Operations, Scientific, or Manufacturing experience Bachelor's Degree & 9 years of Quality, Operations, Scientific, or Manufacturing experience Preferred Qualifications: 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 What you can expect of us From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation. Salary Range 176,370.75USD -238,619.25 USD Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit and follow us on #J-18808-Ljbffr Amgen