**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. **Specialist Manufacturing** **What you will do** Let’s do this. Let’s change the world. In this vital role you will work as a member of the Drug Product Assembly & Packaging organization, this role serves as a key process leader for New Process Introductions (NPI) and Technology Transfers (TT) into the clinical manufacturing facility. The specialist will serve as the clinical manufacturing operations representative for various Final Drug Product teams throughout the clinical/commercialization process. A high degree of interaction is required with Clinical Planning, Supply Chain, Quality, Engineering, Process Development, Global Operations teams, Combination Product Technologies, and other supporting groups. **Responsibilities:** + Primary responsibilities include assessment of NPI’s and TT’s for necessary process, facility/equipment, materials, and training modifications; development of NPI/TT implementation plans in accordance to current business processes; ensuring TT information is completed and sufficient for manufacturing implementation; and coordination/execution of required NPI activities, which may include document preparation/revisions, change control management, manufacturing process modifications, equipment introductions/modifications, and supporting validation/engineering runs. + The position will support and/or be responsible for proper execution of manufacturing/quality systems such as deviations, process and equipment qualification/validation, operational procedures, training, and design/tech transfer for the clinical packaging and device assembly processes. The individual will need to apply process experience, operational expertise, compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. + Works with various NPI/TT support groups to develop, maintain, and implement the NPI/TT project plan. Specialist will function as the NPI project manager and is accountable for NPI scope, schedule, resources, and risk management. Responsibilities include issue resolution in a timely manner to various levels of management, based on impact and complexity. + Engages with network partners to develop process and technology strategies that achieves clinical/commercial development schedules while minimizing transfer risks. + Facilitates the development and optimization of NPI/TT business processes. As applicable, serves as a representative on various global network teams or network-sponsored initiatives to advance the Final Drug Product operational practices and technologies. + Collaborates with Manufacturing, Combination Product Operations, Quality, and Regulatory partners to manage change control processes and respond to regulatory questions and/or audit findings within the scope of the NPI/TT. + Supports generation, revision, review, execution, and approval of relevant technical documents (e.g., manufacturing procedures, protocols, training materials, design control reports, and specifications). Ensures design/process transfer requirements are appropriately implemented and aligned with current manufacturing strategies. + Supports a safe working environment by aligning with all pertinent environmental health/safety practice, rules and regulations. **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek is a collaborative partner with these qualifications. **Basic Qualifications:** Doctorate degree **Or** Master’s degree and 2 years of manufacturing experience **Or** Bachelor’s degree and 4 years of manufacturing experience **Or** Associate’s degree and 8 years of manufacturing experience **Or** High school diploma / GED and 10 years of manufacturing experience **Preferred Qualifications:** + Engineering experience with process equipment design, construction, commissioning, and qualification + Experience with combination product or medical device design development and manufacturing + Knowledge and expertise in device design control, design transfer, and combination products manufacturing + Experience with the development and maintenance of device master records, device history records, and process risk assessments (pFMEA) + Direct experience with regulated environments (e.g. cGMP, OSHA, EPA, etc.) + Fundamentally sound project management/organization, technical writing, digital literacy, and communication/presentation skills + Experience with various quality systems including change control, deviations, corrective and preventative actions, and/or validation practices + Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration. + Excellent teammate prepared to work in and adopt a team-based culture that relies on collaboration for effective decision-making + Experienced in balancing multiple, opposing priorities in a fast-paced environment + Ability to optimally communicate sophisticated technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms **What you can expect from us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. 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 **Apply now** **for a career that defies imagination** Objects in your future are closer than they appear. Join us. **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. **Application deadline** 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. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, 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 and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.