Engineer - Process Development

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Engineer - Process Development

What you will do

Lets do this! Lets change the world!

In this vital role you will be responsible for supporting process development and technical transfer of Amgens synthetic and hybrid drug substance manufacturing processes across all phases of development and commercialization. You will be part of the Drug Substance Technologies organization in Process Development. Chemical engineering fundamentals will be applied to generate process understanding and implement scalable drug substance processes that deliver Amgens pipeline of diverse synthetic and hybrid modalities. The Engineer will partner with a multi-functional group of engineers and scientists to develop and optimize synthetic and hybrid unit operations aligned with the intended phase of technology transfer and manufacturing. This work will include experimental design and execution, data analysis, process risk analysis, process characterization, facility fit assessment, and in-plant support of production operations during process execution and equipment commissioning.

• In a team setting and with limited supervision, design and implement standard experimental, modeling and engineering techniques for process optimization, characterization, and scaleup of chemical processes in innovative facilities.

• Initiate and complete experimental techniques in the lab, kilogram-scale facility, and manufacturing environments.

• Author documents for process understanding, technical transfer, risk assessment, facility fit, and process development and characterization.

• Serve as a technical expert for lab equipment or systems.

• Be an active participant in daily production or development operations when required to meet schedules or to resolve sophisticated problems.

• Routinely monitor manufacturing processes for performance indicators and operations.

• Conceptualize resolutions to processing challenges, provide troubleshooting guidance and recommend process improvements.

• Apply engineering principles and statistical analysis, including design of experiments, to solve process issues and evaluate opportunities for process improvements.

• Communicate and collaborate with External Supply, Manufacturing, Process Development, and Quality departments.

• Contribute to key regulatory and quality activities such as non-conformances, process performance qualification, and continued process verification.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Engineer professional we seek is a teammate with these qualifications.

Basic Qualifications:

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

• Associates degree and 6 years of Engineering or Operations experience OR

• Bachelors degree and 2 years of Engineering or Operations experience OR

• Masters degree

Preferred Qualifications:

• Academic background in Chemical Engineering

• 2+ years of experience in a Process Development or Process Engineering environment, with specific experience in the implementation and support of synthetic or hybrid manufacturing processes

• Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale

• Basic understanding of cGMP requirements

• Experience building and applying first-principle models (e.g., reaction kinetics, mass transfer, separations, distillations, isolations, drying, and hydrodynamics) with proficienc across several modeling platforms

• Knowledge of analytical techniques and solid-state characterization with fluency in a wide variety of techniques including HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, particle size determination, etc.

• Background in statistical analysis/DoE

• Solid understanding of standard plant operations and safety practices

• Project management skills

• Strong verbal communication and presentation skills

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, well 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

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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.