Process Development Sr Scientist (Drug Product NPI)

Career Category Process Development 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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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. Process Development Sr Scientist (Drug Product NPI) What you will do Let’s do this. Let’s change the world. In this vital role you will work as a Process Development (PD) Senior Scientist to support the AML Process Development- Drug Product (DP) / New Product Introduction (NPI) Organization. This group leads AML DP NPI, product lifecycle projects, business case processes, and project implementation. You will join a team focused on development and leading projects to support new product launches, tech transfers and business cases which allow us product portfolio expansion impacting more patients’ lives every day. The primary focus will be in drug products, inspected drug products, and finished drug products manufactured at AML. This is an outstanding opportunity to support advancing our pipeline and transforming Amgen for the future. Manage all phases of project management—from planning and implementation to monitoring, completion, and follow-up—ensuring alignment with goals, timelines, and quality standards. Create comprehensive business cases including technical and financial requirements. Oversee project budgets, resource allocation, and financial tracking to ensure fiscal responsibility. Serve as liaison with management, department heads, and cross-functional teams to ensure project objectives are clearly communicated and aligned across all stakeholders. Identify potential project risks, schedule changes, or resource constraints. Develop and implement solutions to maintain scientific efficiency, quality, and client satisfaction. Design and apply tools, techniques, and processes that support data-driven decision-making and improve project transparency and performance. Maintain strict adherence to domestic and international regulatory requirements, internal policies, and standard operating procedures throughout the project lifecycle. · Manage change controls and deviations using systems like Trackwise. Recommend and implement operational improvements to enhance team effectiveness and project outcomes. · Collaborate with research, manufacturing, quality, and other departments to define requirements and lead efforts for complex system, facility, or process modifications. · Balance competing timelines and priorities, ensuring critical tasks are completed efficiently and project standards for quality and quantity are met. · Provide flexibility to support extended hours, non-standard shifts, and evolving project demands as needed. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Process Development Sr Scientist professional we seek is an individual contributor with these qualifications. Basic Qualifications: Doctorate degree PhD OR PharmD OR MD Or Master’s degree and 3 years of Process Development and/or Manufacturing support experience Or Bachelor’s degree and 5 years of Process Development and/or Manufacturing support experience Preferred Qualifications: Educational background in Engineering or Life Science Change control owner and/or deviation owner background. New Product Introduction experience Knowledge in process validation and regulatory processes Final Drug Product and Packaging Manufacturing experience Experience in devices, assemblies and advance packaging technologies Previous experience in product launches Working knowledge of pharmaceutical/biotech processes (GMP regulated). Understanding and experience with Ariba Sourcing and Contracting Modules. Previous experience in Capital projects and resource allocation Experience with SAP, Trackwise/Veeva, and Project management tools (Smartsheet and/or MS Project). Highly proficient with MS Office, including Excel, Word, and PowerPoint. Bilingual proficiency in English and Spanish, with strong verbal and written communication skills with ability to present at various organization levels. Conflict Resolution, leadership and team building skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being. In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance 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 and an annual site shutdown Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. careers.amgen.com 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. 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. .