Process Development Sr. Engineer (Drug Substance)

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 ENGINEER - DRUG SUBSTANCE

What you will do

Let’s do this. Let’s change the world! In this vital role you will apply your technical expertise in purification sciences to support commercial drug substance manufacturing, solve complex challenges, and lead multi-functional initiatives that drive innovation, compliance, and operational excellence at Amgen Manufacturing Limited (AML)

Specific responsibilities include but are not limited to:

• Provide support, as needed, to clinical and commercial drug substance manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for process changes/improvements and non-conformance investigations.
• Main representative for purification area processes (chromatography, viral filtration, ultrafiltration/diafiltration, bulk fill operations, etc.).
• Analyze manufacturing data trends to identify areas for improvement and proactively mitigate potential issues
• Author/review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections.
• Act as a subject matter expert during change control, assessing the impact of proposed changes on the product and process performance.
• Support new product introductions (NPI), including documentation generation, batch execution support and troubleshooting.
• Drive continuous improvement initiatives to enhance process capability, reduce variability and improve productivity.
• Apply advanced statistical/data analytics techniques to draw conclusions and inform decisions
  

What we expect of you

We are all different! Yet, we all use our unique contributions to serve patients. The Process Development Senior Engineer professional we seek is an individual contributor with these qualifications.

Basic Qualifications:

Doctorate degree in Engineering

OR

Master’s degree in Engineering and 2 years of Engineering Support experience

Or

Bachelor’s degree in Engineering and 4 years of Engineering Support experience

Preferred Qualifications:

• Solid knowledge of protein purification operations and working understanding of biopharmaceutical manufacturing processes.
• Familiarity with validation principles, Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP) within regulated environments.
• Demonstrated problem-solving skills, applying scientific and engineering theory, technical calculations, and creative thinking to develop effective solutions.
• Strong technical writing abilities and experience preparing clear, concise, and compliant documentation.
• Knowledge on statistical analysis tools (Minitab, SPSS, JMP and/or other related tools)
• Skilled in project management, with the ability to align timelines, deliverables, and manage multiple concurrent projects and adapt to shifting priorities.
• Fully bilingual in English and Spanish, with strong verbal communication, documentation, and presentation skills.
• Comfortable working independently with minimal direction, while effectively managing stakeholder expectations across functions.
• Strong interpersonal and facilitation skills to support collaboration across teams and build consensus.
  

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

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.

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.

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.