Engineer, Drug Product Process Engineering

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.

Engineer, Drug Product Process Engineering

What you will do

Let’s do this! Let’s change the world!

The Engineer will join Drug Product Process Engineering team that is part of Commercial Drug Product Technologies at Amgen and will be a key contributor to drug product process development, commercialization, and life cycle management of Amgen’s parenteral product portfolio. The Engineer will be responsible for integrating the knowledge and information generated by cross functional teams with Amgen’s platforms and clinical and/or commercial manufacturing capabilities to ensure success through the commercialization lifecycle. The Engineer will operate in product/process development and aseptic manufacturing environments in a highly matrixed cross functional manner. This position is based in Thousand Oaks, CA at the Amgen headquarters. This role is primarily a first-shift role but may require some time on call during second or third shifts.

In this role, the Engineer will:

• Work with a team of process scientists and/or engineers to design, execute, document, and generate primary data packages related to process development and technology transfer, while developing and applying their experience in aseptic processing, equipment, automation and unit operation characterization

• Support continuous improvements in the drug product development process through technological innovation and application of first principles in process engineering

• Support technology transfers of pipeline and commercial products as well as lifecycle management of products for a variety of parenteral modalities

• Conduct make-a-batch exercises to determine facility fit and identify gaps

• Design and execution of offline and on-site drug product characterization studies

• Evaluation of product impact from manufacturing process, production scale, equipment, and raw material changes

• Author and/or own high-quality process technology transfer and other technical documents

This role provides development opportunities in the following areas:

• Dynamic, matrixed organization and collaboration – the Engineer interfaces with a broad array of partners on a routine basis, providing visibility to those other areas of the business and how these functions work together to meet organizational goals.

• Operational efficiency and business skills application – this role provides an opportunity to apply core technical skills to Amgen’s process development operations.

• Process development – Provide technical input and support to the drug product tech transfer process by executing development studies including filling recipe development, lyophilization process scale-up etc.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

• High school diploma / GED and 8 years of Operations or Process Development experience OR

• Associate’s degree and 6 years of Operations or Process Development experience OR

• Bachelor’s degree and 2 years of Operations or Process Development experience OR

• Master’s degree

Preferred Qualifications:

• M.S. in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related discipline

• Experience in a role that working with cross functional groups to achieve results.

• Highly proficient in presentation skills and the ability to draft technical documents.

• Familiarity with aseptic processing, drug product manufacturing, cGMPs, statistical design, analysis of experiments, and process characterization

• Fill/finish process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools

• The ability to use engineering principles to leverage bench and pilot scale models for process performance characterization

• Knowledge of formulation, filling, lyophilization, visual inspection, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling and the associated GMP/Device documentation and regulatory filings

• Highly proficient in presentation skills and the ability to draft technical documents.

• Ability to learn and act on dynamic information at a rapid pace

• Technology transfer experience across different development phases, fill-finish process scale-up, and the use of gap analysis, root cause analysis, and risk assessment tools

• Strong experience in a matrix team environment, interacting with Attribute Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and Quality

What you can expect of us

As 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 possible

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

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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 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.