Amgen Inc. Thousand Oaks , CA 91360
Posted 2 months ago
JOB ID: R-184037 LOCATION: US - California - Thousand Oaks WORK LOCATION TYPE: On Site DATE POSTED: Mar. 13, 2024 CATEGORY: Engineering SALARY RANGE: 87,178.00 USD - 107,393.00 USD
HOW MIGHT YOU DEFY IMAGINATION?
You've 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 mission-to serve patients-drives all that we do. It is key to our becoming one of the world's 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
Let's do this. Let's 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 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.
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:
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 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.
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Amgen Inc.