Sr Specialist Manufacturing - Aseptic Compliance

Company: Amgen
Location: Thousand Oaks
Posted on: June 29, 2025

Job Description:

Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Sr Specialist Manufacturing - Aseptic Compliance What you will do Lets do this. Lets change the world. In this vital role you will play a part in maintaining aseptic control and compliance for the sites drug product filling operations, with a specialized focus on owning and advancing the Media Program and Aseptic Behavior Program strategy. Aseptic Compliance Oversight and Aseptic Behavior Program Serve as a key aseptic compliance leader supporting drug product filling operations at ATO B20. Drive proactive aseptic behavior and contamination control culture through floor presence, coaching, and mentoring. Conduct routine aseptic audits and observations to identify risks and opportunities for improvement. Lead investigations for aseptic deviations, non-conformances, and contamination events. Own and maintain key procedures and training content related to aseptic practices. Own and maintain the B20 contamination control strategy. Support Airflow visualization studies. Media Program Act as the program owner for Media Fills at ATO B20, ensuring alignment with global standards and Annex 1 revisions. Lead cross-functional planning and follow through of APS events, from protocol development through closure and trending. Perform gap assessments and develop risk-based strategies for media simulation scope and frequency. Analyze EM and personnel monitoring data associated with APS, driving data-based decisions. Network Collaboration & Best Practices Engage with aseptic experts across the Amgen manufacturing network to align on global expectations and standard methodologies. Represent ATO B20 in network forums and contribute to the development and harmonization of aseptic and media fill practices. Leverage benchmarking and cross-site lessons to strengthen local contamination control strategies. Training & Readiness Deliver aseptic technique training and qualification to operators and support staff. Champion readiness activities for regulatory inspections and internal audits, focusing on aseptic control narratives. Cross-functional Leadership Collaborate with Quality Assurance, Environmental Monitoring, Microbiology, and Engineering to ensure well-rounded contamination control. Present APS and Aseptic data, trends, and risk assessments to leadership and regulatory inspectors as needed. Draft and support regulatory filings. 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 go getter with these qualifications. Basic Qualifications: Doctorate degree in Microbiology, Biotechnology, Engineering, or related scientific field and 2 years of Drug Product Manufacturing Aseptic Compliance experience Or Masters degree in Microbiology, Biotechnology, Engineering, or related scientific field and 4 years of Drug Product Manufacturing Aseptic Compliance experience Or Bachelors degree Microbiology, Biotechnology, Engineering, or related scientific field and 6 years of Drug Product Manufacturing Aseptic Compliance experience Or Associates degree in Microbiology, Biotechnology, Engineering, or related scientific field and 10 years of Drug Product Manufacturing Aseptic Compliance experience Or High school diploma / GED and 12 years Drug Product Manufacturing Aseptic Compliance experience Preferred Qualifications: Experience with aseptic filling operations in a sterile drug product facility Working knowledge of global aseptic regulations (Annex 1, 21 CFR Parts 210/211) Prior ownership of Media Fill/APS program or significant involvement in its execution. Experience interacting with regulatory agencies during inspections. Cross-functional leadership and ability to influence at the network level What you can expect of 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, well 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 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. 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.

Keywords: Amgen, Whittier , Sr Specialist Manufacturing - Aseptic Compliance, Science, Research & Development , Thousand Oaks, California