Engineer I Upstream Drug Substance Technologies and Engineering

Career Category

Engineering

Job Description

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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 – Upstream Drug Substance Technologies and Engineering

What you will do

Let’s do this. Let’s change the world. Amgen is seeking an Engineer to join the Drug Substance Technology Engineering team supporting Amgen Thousand Oaks (ATO) Drug Substance Manufacturing facilities.

The role will support technology transfer and process validation for human therapeutic products (biological drug substance) across the clinical and commercial manufacturing space.

• Responsibility 1Transfer cell culture drug substance processes and perform process improvements from the laboratory into the manufacturing facility and between manufacturing sites
• Provide process validation support for late stage commercial processes
• Provide on-the-floor technical support for successful scale-up and transfer of process technology, and for clinical or commercial manufacturing operations
• Provide routine process monitoring and troubleshooting
• Perform data trending and statistical process analysis
• Provide technical contributions for process related deviations (NCs), CAPAs and change controls
• Identify and support process related operational excellence opportunities
• Represent process development and collaborate with other functions such as Manufacturing, Quality, and Regulatory

What we expect of you

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

Basic Qualifications:

Master’s degree
OR
Bachelor’s degree and 2 years of Process Development experience
OR
Associate’s degree and 6 years of Process Development experience
OR
High school diploma / GED and 8 years of Process Development experience

Preferred Qualifications:

• Master’s degree in Chemical/Biochemical Engineering or related subject area
• 3 + years of experience in Process Engineering related to biochemical engineering and/or protein biochemistry, scale-up principles and manufacturing of biologics (cGMP)
• Upstream process knowledge and hands on cell culture and/or purification pilot/clinical/commercial experience with regard to the manufacture of a biological drug substance
• Experience working in/supporting a commercial cGMP manufacturing facility
• A firm understanding of cell culture process and related equipment; scale-up from bench to commercial scale, mass oxygen transfer capabilities, metabolism profiling, influence of raw material attributes and impact of process deviations to growth and quality attributes
• Knowledge of aseptic processing/techniques, harvest and clarification processes used in mammalian cell culture processes AND/OR a good understanding of purification process and associated equipment; chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations
• Process development (PD) experience supporting cGMP manufacturing at large scale
• Strong capability in scientific/engineering/laboratory analysis, troubleshooting and ability to apply sophisticated problem resolution abilities
• Ability to develop and follow detailed protocols
• Independently motivated with ability to multi-task and work in teams
• Excellent written and verbal communication with experience with technical writing and presentations

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…