Senior Manager - Drug Substance Technology & Engineering

Senior Manager – Drug Substance Technology & Engineering Amgen is a global leader in biotechnology, focused on advancing medicines for oncology, inflammation, general medicine, and rare disease. The company’s mission is to serve patients living with serious illnesses, and the team at the Thousand Oaks, California plant plays an essential role in translating scientific discoveries into life‑changing therapies. Location: Thousand Oaks, CA | Travel: Up to 10% domestic and international. Key Responsibilities Support the development, scale‑up, tech transfer, and manufacturing execution of cGMP clinical and commercial downstream purification processes, including harvest, clarification, chromatography (Protein A, AEX, CEX, etc.), viral filtration, UF/DF, and sterile filtration. Apply engineering principles and statistical analysis to: Identify, develop, and implement downstream process improvements in the manufacturing facility. Resolve technical issues observed during scale‑up and/or manufacturing execution. Manage escalation and on‑floor support as required to achieve successful scale‑up and manufacturing objectives. Interface with process development teams to ensure processes are robust and designed to deliver all 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 continuous process verification, process monitoring, optimization, complex investigation, and product lifecycle management. Ensure safety and compliance of process development activities. Collaborate with other site functions and network drug substance teams to deliver plant goals. Lead cross‑functional teams to resolve complex problems while meeting quality, schedule, and cost objectives. Ensure manufacturing operations are aligned with the registered process. Provide support for regulatory filing, inspection, and other CMC activities. Serve as a member of the ATO DSTE leadership team, utilizing network thinking and innovative approaches to advance the drug substance organizational capabilities. Supervising Others / Team Experience Create multi‑year technical strategies for advancing business performance. Ensure that safe practices are followed. 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 adequate feedback through coaching and effective performance appraisal and development planning. Initiate and encourage scientific collaboration with groups outside the department. Manage project resources (material, labor, time, etc.) 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 Basic Qualifications: Doctorate degree and 2 years of biologics process development or commercial‑scale technical support experience OR Master’s degree and 6 years of biologics process development or commercial‑scale technical support experience OR Bachelor’s degree and 8 years of biologics process development or commercial‑scale technical support experience OR Associate’s degree and 10 years of biologics process development or commercial‑scale technical support experience OR High school diploma / GED and 12 years of biologics process development or commercial‑scale technical support experience. In addition to meeting at least one of the above requirements, you must have a minimum of 2 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Preferred Qualifications: 8+ years of experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP). 5+ years directly managing people and/or leadership experience leading teams, projects, programs, or directing allocation of 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 and ability to interact effectively with diverse internal and external 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. Benefits Amgen offers a Total Rewards Plan, including: A comprehensive employee benefits package with a retirement and savings plan, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program and, for field sales representatives, a sales‑based incentive plan. Stock‑based long‑term incentives. Award‑winning time‑off plans. Flexible work models where possible. Equal Opportunity Employer 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 Amgen