Specialist, Manufacturing - Production Process Owner

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity‑related conditions. 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 – Production Process Owner What You Will Do Let’s do this. Let’s change the world. At Amgen, our mission—to serve patients—drives everything we do. As a Specialist Manufacturing in Drug Product (DP) Operations at our Thousand Oaks (ATO) manufacturing site, you will play a key role in ensuring our commercial and clinical manufacturing processes are compliant, efficient, and continuously improving. This role will be supporting Major Deviations from a DP Process Standpoint. Key Responsibilities: Deviation and CAPA Management Support timely investigation and resolution of manufacturing deviations. Participate in root cause analyses (RCA) and human performance evaluations. Contribute to the development and implementation of effective corrective and preventive actions (CAPAs) and monitor CAPA effectiveness. Documentation and Process Management Initiate, revise, and approve controlled manufacturing documents within Amgen’s electronic document management system (CDOCs). Serve as document author, owner, reviewer, or data verifier, ensuring accuracy and compliance with current GMP and Amgen standards. Maintain documentation to accurately reflects operational practices and regulatory requirements. Process Implementation and Project Execution Support implementation of new processes, equipment, and major initiatives within Drug Product operations. Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness. Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations. Operational Performance and Data Analytics Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement. Develop and implement data-driven solutions to improve yield, reliability, and compliance. Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire, ensuring configuration alignment with process design and GMP requirements. Validation and Process Control Assist in developing and executing process validation protocols and reports. Collect, analyze, and interpret validation and process monitoring data to ensure process robustness and compliance. Support establishment of process parameters, control limits, and performance reporting. Change Control and Continuous Improvement Support change control activities to ensure GMP, regulatory, and operational compliance. Evaluate and justify process or equipment changes and assist with project execution. Participate in continuous improvement and operational excellence initiatives to enhance safety, quality, and efficiency within DP operations. What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a highly organized and collaborative individual with strong project coordination, communication, and problem-solving skills. 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: Advanced degree (Master’s or Ph.D.) in Engineering, Biotechnology, or related field Experience in aseptic Drug Product or biologics manufacturing Previous experience in Root Cause Analysis and Major Deviations Knowledge of process validation, deviation management, and change control Strong analytical and problem-solving skills with experience using data visualization tools (Spotfire, JMP, Excel) Excellent written and verbal communication skills and ability to collaborate across functions Competencies for Success Operational Excellence: Demonstrates attention to detail, prioritizes quality and compliance, and drives process improvements. Technical Expertise: Applies technical knowledge to evaluate, troubleshoot, and optimize manufacturing processes. Collaboration: Builds strong cross-functional relationships and fosters teamwork across disciplines. Accountability: Takes ownership of deliverables and ensures timely completion of commitments. Continuous Improvement: Identifies and implements opportunities to enhance manufacturing performance and reliability. 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 where possible. Refer to the Work Location Type in the job posting to see if this applies. 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. 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 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. #J-18808-Ljbffr Amgen