Process Development Sr. Scientist (Core Technologies)

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. 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.

PROCESS DEVELOPMENT SENIOR SCIENTIST (CORE TECHNOLOGIES)

What you will do

Let’s do this. Let’s change the world! In this vital role you will be involved in researching and developing new and enhanced bio-pharmaceutical manufacturing processes. This includes applying scientific knowledge and Lean Manufacturing/Six Sigma principles to design and conduct experiments, analyzing results, and proposing process improvements to enhance product quality and production efficiency.

Specific responsibilities include but are not limited to:

• Lead the development and implementation of advanced sterile injectables manufacturing technologies to improve product quality, throughput, and process robustness across final drug product operations.
• Drive technology and process improvements aimed at waste reduction, faster changeovers, and risk mitigation during scale-up.
• Deliver measurable outcomes such as increased yield and throughput, reduced cost and variability, and fewer deviations, while influencing cross-site stakeholders.
• Independently design, complete, and analyze experiments, determining methods and procedures for new assignments and making impactful decisions within the team and department.
• Apply Design of Experiments (DOE) within DMAIC/DFSS frameworks to quantify and reduce variability.
• Demonstrate technical mastery by introducing novel approaches, championing Operational Excellence through Lean Six Sigma, and mentoring colleagues to elevate team capabilities.
• Analyze and interpret complex datasets using advanced methodologies and tools to inform strategic decisions and drive continuous improvement.
• Use advanced DOE, statistical, and AI-based tools for process characterization, validation, and signal detection; advocate for Quality by Design (QbD) and digital validation practices.
• Manage end-to-end project execution, including planning, resource allocation, risk assessment, milestone tracking, and team member communication, ensuring alignment with organizational goals and compliance standards.
• Develop detailed project plans and proactively communicate decisions to ensure timely tasks' completion.
• Steward technical documentation, harmonize practices across teams and sites, and ensure audit readiness.
• Communicate scientific and technical information effectively across functions and external audiences; author technical reports, protocols, and regulatory documents; present proposals and results to leadership.
• Build and manage stakeholder relationships, collaborating across functions and with external partners to integrate innovative technologies and achieve shared objectives.
• Support non-standard operations, including extended hours or weekends, based on business needs.

What we expect of you

We are all different! Yet, we all use our unique contributions to serve patients. The Process Development Sr. Scientist professional we seek is a technical leader with these qualifications.

Basic Qualifications:

Doctorate degree

Or

Master’s degree and 3 years of Process Development, Engineering and/or Manufacturing support experience

Or

Bachelor’s degree and 5 years of Process Development, Engineering and/or Manufacturing support experience

Preferred Qualifications:

• Educational background in Life Sciences or Engineering, with hands-on experience in cGMP, Biopharma/Biotech regulated environments and a strong quality and compliance mentality.
• Leadership in developing and executing characterization and validation strategies, including protocol authorship, method selection, test case development, and risk assessments.
• Lean Six Sigma certification or demonstrated success in delivering impactful Lean/Six Sigma projects with sustained improvements.
• Working knowledge of GxP regulations, user requirements, and audit readiness, with practical experience in aseptic processing, visual inspection, and sterile injectable technologies (including exposure to AVI systems).
• Strong communication skills in both Spanish and English, with the ability to translate complex technical concepts for non-technical stakeholders.
• Excellent time and project management skills, with flexibility to adapt to changing priorities and deliver results on schedule and within budget.
• Advanced problem-solving and conflict-resolution abilities, supported by proficiency in data analytics, statistical tools, and standard office applications.
• Experience in AI-enabled development, including identifying, evaluating, and deploying AI/ML solutions for experimental design, document generation, deviation analysis, and knowledge retrieval, with human-in-the-loop oversight.
• Demonstrated success in continuous improvement initiatives, including defining critical metrics (e.g., cycle-time reduction, right-first-time, deviation recurrence, reviewer effort) and communicating outcomes to leadership.
• Commitment to data stewardship, ensuring data integrity (ALCOA+), privacy, and appropriate classification when using AI, and adhere to approved enterprise platforms and data sources.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• 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 and an annual site shutdown
• Flexible work models, including remote work arrangements, where possible

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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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 you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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