Specialist Manufacturing - Drug Product Investigation Support

Career Category Manufacturing 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. 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 - Drug Product Investigation Support What you will do Let’s do this. Let’s change the world. In this vital role, you will support the Drug Product Manufacturing Investigation Team within the Amgen Thousand Oaks Clinical Supply Organization. This position is responsible for assisting with the coordination, execution, and timely completion of minor and major manufacturing deviation investigations. The role will partner closely with major deviation investigators, manufacturing personnel, quality representatives, and subject matter experts to ensure investigations are completed in accordance with quality and regulatory requirements. This individual will play a key role in supporting deviation investigation activities, tracking progress, monitoring manufacturing-related deviations, and driving actions to completion to ensure investigation timelines are met. Responsibilities Support the Drug Product Manufacturing Investigation Team by assisting with the execution and timely completion of manufacturing deviation investigations. Assist investigation owners with gathering information, attending investigation related meetings, documenting findings, and tracking investigation deliverables. Manage the scheduling, prioritization, and timely completion of minor manufacturing deviations while supporting the coordination of major investigations. Author and own minor manufacturing deviations, including documenting the event, performing the required assessment, and ensuring timely completion in accordance with quality system requirements. Coordinate cross-functional activities with Manufacturing, Quality Assurance, Process Engineering, Process Development, Quality Control, and other support functions. Assist with data collection, trend analysis, and documentation needed to support root cause analysis, product impact assessments, and CAPA development. Track investigation milestones, CAPAs, and action items through closure and escalate potential timeline risks when needed. Develop and maintain minor deviation metrics and reports to provide visibility into the status, cycle times, and compliance performance. Support continuous improvement initiatives focused on investigation processes, compliance, and operational efficiency. Maintain accurate and compliant documentation within electronic quality management systems. Support the investigation team with inspection and audit readiness activities, including investigation support and documentation. 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: 3+ years of experience in GMP manufacturing, quality systems, investigations, or related pharmaceutical/biotechnology operations. Experience supporting manufacturing investigations, deviations, CAPAs, or quality systems. Strong project coordination and organizational skills with the ability to manage multiple priorities simultaneously. Experience tracking quality records and driving activities to completion within established timelines. Excellent written and verbal communication skills. Strong attention to detail and technical documentation skills. Ability to work effectively in a cross-functional matrix environment and build strong partnerships. Knowledge of GMP regulations, deviation management, investigation processes, and CAPA systems 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. 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. 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. . Salary Range 107,545.40USD -145,502.60 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