Amgen

A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.. + 3 + years of experience in Process Engineering related to biochemical engineering and/or protein biochemistry, scale-up principles and manufacturing of biologics (cGMP). + Upstream and/or Downstream process knowledge and hands on cell culture and/or purification pilot/clinical/commercial experience with regard to the manufacture of a biological drug substance. + 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

downstream

**HOW MIGHT YOU DEFY IMAGINATION?** Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Upstream/Downstream Engineer- Technical Operations **Live** **What you will do** Lets do this. Lets change the world. 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 uses its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Come join us! 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 new product introduction, technology transfer and process validation for human therapeutic products (biological drug substance) across the clinical and commercial manufacturing space. **Responsibilities include:** + Transfer cell culture/purification 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 **Win** **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek will possess these qualifications. **Basic Qualifications:** Masters degree **Or** Bachelors degree and 2 years of Process Development experience **Or** Associates degree and 6 years of Process Development experience **Or** High school diploma / GED and 8 years of Process Development experience **Preferred Qualifications:** + Masters 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 and/or Downstream 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 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 + Process development (PD) experience supporting cGMP manufacturing at large scale + Strong capability in scientific/engineering/laboratory analysis, trouble shooting 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 **Thrive** **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. 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. Amgen offers a Total Rewards Plan comprising 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 including: + 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 and bi-annual company-wide shutdowns + Flexible work models, including remote work arrangements, where possible **Apply now** **for a career that defies imagination** Objects in your future are closer than they appear. Join us. **careers.amgen.com** Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. 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. #J-18808-Ljbffr

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