Senior Manager - Drug Substance Technology & Engineering

Senior Manager – Drug Substance Technology & Engineering Location: Thousand Oaks, CA. Travel: Up to 10% domestic and international. Responsibilities Support the development, scale‑up, technology transfer, and manufacturing execution of cGMP clinical and commercial downstream purification processes—including harvest, clarification, chromatography (ProteinA, AEX, CEX, etc.), viral filtration, UF/DF, and sterile filtration. Apply engineering principles and statistical analysis to identify, develop, and implement downstream process improvements. Resolve technical issues during scale‑up or manufacturing execution of purification processes; manage escalations and provide on‑floor support to achieve objectives. Interface with process development teams to ensure processes are robust, deliver quality attributes, and enable manufacturing success. Collaborate with Process Development, Quality, Manufacturing, Regulatory, Validation, and Supply Chain to drive continuous improvements. Lead site activities for process verification, monitoring, optimization, complex investigation, and product lifecycle management while ensuring safety and compliance. Coordinate with other site functions and drug‑substance teams to deliver plant goals. Lead cross‑functional teams to resolve complex problems meeting quality, schedule, and cost objectives. Ensure manufacturing operations align with registered processes and provide support for regulatory filing, inspection, and CMC activities. Serve as a member of the ATO DSTE leadership team, utilizing network thinking to advance organizational capabilities. Supervising Others / Team Experience Create multi‑year technical strategies for advancing business performance. Ensure safe practices are followed in the workplace. Provide mentoring and expertise to staff on the downstream team. Motivate, develop, and coach staff while promoting team collaboration. Apply effective management practices in the direction and development of others. Leadership and Influence Identify and negotiate resources and develop timelines for project activities. Collaborate within the department and interdepartmentally. Provide scientific and technical leadership. Ensure department staff are adequately developed and trained. Provide feedback through coaching, performance appraisal, and development planning. Initiate and encourage scientific collaboration with groups outside the department. Manage project resources and elevate relevant issues to project lead and line management. Build and maintain effective collaborations with partner organizations. Decision Making and Judgment Anticipate, proactively detect, and address problems related to departmental and interdepartmental activities. Inform and consult with department head and senior staff appropriately. Qualifications Doctorate degree and 2years of biologics process development or commercial‑scale technical support experience. Master’s degree and 6years of biologics process development or commercial‑scale technical support experience. Bachelor’s degree and 8years of biologics process development or commercial‑scale technical support experience. Associate’s degree and 10years of biologics process development or commercial‑scale technical support experience. High school diploma/GED and 12years of biologics process development or commercial‑scale technical support experience. Minimum 2years of experience directly managing people and/or leading teams, projects, programs, or allocating resources (managerial experience may run concurrently with the required technical experience). Preferred Qualifications 8+ years of experience in a technical role supporting biotechnology processes within regulated environments (cGMP). 5+ years of experience directly managing people and/or leading teams, projects, programs, or allocating resources. Strong and in‑depth expertise in purification processes. Experience in process scale‑up, technology transfer, process validation, troubleshooting, and complex investigation. Strong oral and verbal communication skills; ability to interact effectively with diverse stakeholders. Experience developing staff to reach their full potential. Knowledgeable in regulatory filings and inspections. Familiarity with operational aspects of commercial biopharma manufacturing. Familiarity with statistical analysis, analytical methods, and product quality attributes relevant to biological processing. Compensation Expected annual salary range: $148,715.15 – $201,202.85 (U.S. only). Benefits Comprehensive employee benefits package including health, dental, and vision coverage; life and disability insurance; flexible spending accounts. Retirement and savings plan with generous company contributions. Discretionary annual bonus program and stock‑based long‑term incentives. Award‑winning time‑off plans and flexible work models where possible. EEO Statement 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. #J-18808-Ljbffr