Engineer I Upstream Drug Substance Technologies and Engineering

1001 Amgen Inc.; Thousand Oaks (CA); On-site; USD 88,000 - 119,000; Full time

Job summary

Amgen Inc. is seeking an Engineer to join the Drug Substance Technologies and Engineering team at Thousand Oaks. The role focuses on technology transfer and process validation for human therapeutic biologics across clinical and commercial manufacturing spaces.

The candidate will transfer cell culture drug-substance processes, support late-stage validation, and provide on-floor technical support for scale-up and transfer, while collaborating with Manufacturing, Quality, and Regulatory teams.

Qualifications

• Master’s or Bachelor’s with PD experience in process development.
• Upstream cell culture and purification knowledge for biologics (cGMP).
• Experience with large-scale GMP manufacturing and tech transfers.

Responsibilities

• Transfer cell culture drug-substance processes into manufacturing and between sites.
• Support late-stage process validation for commercial processes.
• Provide on-floor technical support for scale-up and tech transfer.
• Conduct routine process monitoring and troubleshooting.
• Analyze data trends and contribute to deviations and CAPAs.

Skills

Cell culture

Process engineering

Biochemical engineering

Analytical skills

Technical writing

Education

Master’s degree in Chemical Engineering

Bachelor’s degree in Engineering or related

Tools

Chromatography

Ultrafiltration

Process validation

Job description

Engineer - 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.

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.

Responsibilities

• Transfer 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 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 where possible

Salary Range

Salary Range 88,281.00USD -119,439.00 USD

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

Equal Opportunity Employer

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Application Materials

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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen