Amgen Inc
Engineer - Drug Substance Technology & Engineering
US - California - Thousand Oaks · Mid
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About the role
- Join Amgen's Mission of Serving Patients
- At Amgen, if you feel like you're part of something bigger, it's because you are.
- Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases.
Responsibilities
- Amgen discovers, develops and delivers innovative human therapeutics.
- The Engineer will provide technology transfer, process validation, and manufacturing support for human therapeutic products (biological drug substance) in clinical development through commercial production.
- You will work as a member of a team of engineers and scientists, as you use engineering principles to implement manufacturing processes in a cGMP environment.
- The successful candidate will apply process engineering knowledge in support of technology transfer and clinical and commercial drug substance manufacturing at Amgen's Thousand Oaks site.
- Support process validation for late-stage commercial processes.
- Provide on-the-floor technical support for process scale-up and technology transfer, as well as clinical and commercial manufacturing operations.
- Perform routine and nonroutine process monitoring and troubleshooting.
- Support nonstandard shift schedules and extended hours as business needs require.
- Trend process data and perform statistical analyses.
- They drive our work, our values, and everything we do at Amgen.
Requirements
- Bachelor's degree and 2 years of Process Development experience
- Associate's degree and 6 years of Process Development experience
- High school diploma / GED and 8 years of Process Development
Nice to have
- 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)
- Downstream process knowledge and hands on 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 purification process and related equipment
- scale-up from bench to commercial scale, chromatography, viral inactivation, viral filtration, ultrafiltraiton and diafiltration, and impact of process deviations to yield 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
Compensation
- 88,281.00USD -119,439.00 USD
Benefits
- To foster a setting in which all staff may excel, we support a variety of growth opportunities, from training and education to expanding current job responsibilities.
Company info
- 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.
- If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team.
- Advancing science and helping patients - these dual passions are ingrained in our culture.
- Our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.
- For staff around the world, our mission to serve patients and our commitment to science makes Amgen a place where we can make a positive difference in people's lives while pursuing a challenging and fulfilling career.
Equal opportunity
- 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.
- Please contact us to request accommodation.
- 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.
Visa & Work Authorization
- Sponsorship for this role is not guaranteed.
This listing is sourced directly from Amgen Inc's careers page and normalized into a canonical job model.