Global Operations Sr Director, Biosimilars

Company: Amgen SA
Location: Thousand Oaks
Posted on: June 2, 2025

Job Description:

Join Amgen's Mission of Serving PatientsAt 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. 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.Global Operations Sr Director, BiosimilarsWhat you will doLet's do this. Let's change the world! Amgen's industry-leading Biosimilars Business Unit (BBU) is advancing a growing portfolio of high-impact, late-stage programs that are central to Amgen's long-range strategic priorities. We are seeking an experienced Global Operations Leader (GOL) to lead two of these key programs. One program is preparing for a major regulatory submission milestone, while the second is progressing through late-stage development and commercialization planning. The selected leader will also serve as Product Team Lead (PTL) for one of these programs-accountable for its cross-functional strategy and execution.This Senior Director-level role is enterprise-critical, with high business complexity, visibility to senior leadership, and direct impact on Amgen's long-range strategic priorities. The GOL will report to the Executive Director, Global Operations Therapeutic Area (TA) Head, and represent Biosimilars Operations in cross-functional and governance forums, including Product Strategy Teams (PTs), Product Delivery Teams (PDTs), and commercial and operations leadership committees.Key Responsibilities

• Serve as GOL for two key biosimilar programs, ensuring operational integration and execution from development through commercialization.
• Act as PTL for one asset, leading cross-functional team strategy and execution across functions including Regulatory Affairs, Chemistry Manufacturing and Controls (CMC), Clinical Development, Commercial, Quality, and Supply Chain.
• Represent Operations as a core member of the Product Strategy Team (PT), ensuring strategic consideration of supply planning, compliance, manufacturing technology, process economics, sourcing, and market access.
• Lead the Product Delivery Team (PDT) in the development of regulatory submissions (e.g., Investigational New Drug [IND], Biologics License Application [BLA], or Marketing Authorization Application [MAA]), as well as launch readiness and life cycle planning.
• Identify and resolve cross-functional risks, enable fast and informed decisions, and drive alignment across global stakeholders.
• Operate with an enterprise mentality, advocating for the program's needs while contributing to broader organizational priorities.Travel Requirement: Up to 10%, domestic and internationalWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a collaborative partner with these qualifications.Basic Qualifications:Doctorate degree and 5 years of experience in Process Development, Operations, or Research & Development (R&D)OrMaster's degree and 8 years of experience in Process Development, Operations, or Research & Development (R&D)OrBachelor's degree and 10 years of experience in Process Development, Operations, or Research & Development (R&D)Preferred Qualifications:
  • Advanced degree in Science or Engineering
  • 12+ years of experience in the biotechnology or pharmaceutical industry, including leadership in Process Development, Manufacturing, Supply Chain, or Quality
  • Experience in biosimilar or complex biologics development and commercialization
  • Demonstrated success leading regulatory submissions (e.g., BLA, MAA) and commercial launch planning
  • Broad cross-functional exposure including Regulatory Affairs, Clinical Development, or Finance
  • Ability to manage ambiguity and complexity; strong analytical and strategic thinking skills
  • Skilled communicator with the ability to influence across all levels of the organization
  • Strong project management and prioritization capabilitiesKey Competencies
    • Be Science-Based / Ensure Quality: Aligns scientific and operational inputs to ensure compliant product delivery
    • Compete Intensely and Win: Optimizes supply chain, timelines, and cost efficiency for patient and business impact
    • Work in Teams: Integrates cross-functional expertise to align around common goals
    • Communicate and Be Accountable: Leads with clarity, owns outcomes, and enables cross-functional decision-makingWhat you can expect of usAs 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, including remote and hybrid work arrangements, where possibleApply now and make a lasting impact with the Amgen team.careers.amgen.comIn 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 deadlineAmgen anticipates accepting applications until 6/6/2025; however, we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.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.
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Keywords: Amgen SA, Santa Ana , Global Operations Sr Director, Biosimilars, Executive , Thousand Oaks, California