ThousandOaksRecruiter Since 2001
the smart solution for Thousand Oaks jobs

Senior Process Engineer

Company: Amgen
Location: Thousand Oaks
Posted on: March 27, 2020

Job Description:

Amgen is seeking a Senior Process Development Engineer to join the Drug Substance Process Engineering team at our Amgen Thousand Oaks (ATO) facilities. Our mission is to translate processes under development to commercial reality for patients through scientific expertise and engineering innovation. We achieve this mission by providing process engineering and process validation support for human therapeutic products in clinical development all the way through commercial production.The Senior Process Development Engineer will apply cell culture and/ or purification process engineering knowledge in support of technology transfer and clinical and commercial drug substance manufacturing. The support role will be primarily focused on a newly constructed, next generation manufacturing facility, utilizing innovative single use technology and focused on the advancement of Amgen's exciting oncology pipeline. In addition, they will partner with manufacturing, quality, and analytical and process scientists to support the start-up, validation and regulatory licensure of this dynamic single-use manufacturing facility.Job Responsibilities:

  • Transfer cell culture/purification drug substance processes and process improvements from the laboratory into GMP manufacturing facilities and between manufacturing sites
  • Perform commercial tech transfers of late stage Amgen products in manufacturing facilities
  • Design and execute process validation studies for late stage commercial processes
  • Deliver technical support for flawless scale-up and transfer of manufacturing process technology, and during clinical or commercial manufacturing execution
  • Provide routine process monitoring and troubleshooting using advanced digital tools
  • Perform data trending and statistical process analysis
  • Provide technical guidance and lead investigations for process related deviations, CAPAs, and change controls
  • Identify and support operational excellence opportunities to improve the productivity and robustness of Amgen's manufacturing processes
  • Represent process development to plant management and collaborate with other functions such as Facilities Engineering, Quality, and Regulatory Compliance
  • Manage technical projects that may include experiment, equipment, or process design
  • Present process performance and project updates at team and management meetings
  • Support regulatory filings and inspectionsBasic Qualifications:Doctorate degreeORMaster's degree and 3 years of experience in Engineering or OperationsORBachelor's degree and 5 years of experience in Engineering or OperationsORAssociate's degree and 10 years of experience in Engineering or OperationsORHigh school diploma / GED and 12 years of experience in Engineering or OperationsPreferred Qualifications:
    • Master's Degree in Chemical/Biochemical Engineering
    • 3+ years Process Engineering experience related to biochemical engineering and/or protein biochemistry, scale-up principles, and manufacturing of biologics (cGMP)
    • Background in biologics tech transfer into commercial facilities
    • Experience working in or supporting a commercial cGMP manufacturing facility
    • Upstream and/or downstream process knowledge
    • Knowledge of cell culture processes/ equipment; scale up, mass/oxygen transfer capabilities impact on metabolism, process deviations, raw materials and quality attributes OR
    • Knowledge of, harvest and purification processes knowledge / equipment; chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations
    • Demonstrated strengths in scientific/engineering/laboratory analysis, troubleshooting and problem solving
    • 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
    • Process development and optimization experience with late stage or commercial products
    • Experience with supervision or direct management of technical staffJoin UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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, or disability status.

Keywords: Amgen, Thousand Oaks , Senior Process Engineer, Engineering , Thousand Oaks, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Engineering Jobs


Front End (React) Engineer - Entertainment Analytics
Description: Minimum Required Skills React.JS, TypeScript, MySQL, Ruby On Rails, Front End Engineering, Data Visualization, Product Engineering, Web Application Development, Backend Frameworks, NODE If you are a Front (more...)
Company: CyberCoders
Location: Culver City
Posted on: 04/4/2020

Mac Tools Seeking Mechanics - Technicians - Training Provided
Description: Build a Great Career and a Quality Life with Mac Tools. br br Feel the freedom and independence of working on your own, in a stress free environment - with no one to answer to, except yourself Join (more...)
Company: Mac Tools
Location: Lawndale
Posted on: 04/4/2020

Android Engineer
Description: An Eco-friendly startup in an up and coming market is looking to add an Android Engineer to their growing team. They have received millions of dollars in funding and are looking to expand their team with (more...)
Company: Jobspring
Location: Los Angeles
Posted on: 04/4/2020


Mac Tools Seeking Mechanics - Technicians - Training Provided
Description: Build a Great Career and a Quality Life with Mac Tools. br br Feel the freedom and independence of working on your own, in a stress free environment - with no one to answer to, except yourself Join (more...)
Company: Mac Tools
Location: South El Monte
Posted on: 04/4/2020

Lead .NET Engineer
Description: Minimum Required Skills .NET Core, C, ASP.NET If you've been effective in leading your team to success as a .NET Developer, read on... Our decades of experience in the enterprise fulfillment industry (more...)
Company: CyberCoders
Location: Valencia
Posted on: 04/4/2020

Mac Tools Seeking Mechanics - Technicians - Training Provided
Description: Build a Great Career and a Quality Life with Mac Tools. br br Feel the freedom and independence of working on your own, in a stress free environment - with no one to answer to, except yourself Join (more...)
Company: Mac Tools
Location: Hawaiian Gardens
Posted on: 04/4/2020

Lead Android Engineer
Description: Minimum Required Skills Android Application Development, Java Kotlin, data structure experience, Android architecture - MVP MVVM MVI, Computer Science Fundamentals Lead Android Engineer - East LA We are (more...)
Company: CyberCoders
Location: Los Angeles
Posted on: 04/4/2020

Mac Tools Seeking Mechanics - Technicians - Training Provided
Description: Build a Great Career and a Quality Life with Mac Tools. br br Feel the freedom and independence of working on your own, in a stress free environment - with no one to answer to, except yourself Join (more...)
Company: Mac Tools
Location: Signal Hill
Posted on: 04/4/2020

Senior Windows Engineer / $175,000
Description: Based in Santa Monica, this established fintech company makes financing for life's big purchases easier by connecting borrowers to lenders. From individual customers to small businesses, their platform (more...)
Company: Jobspring
Location: Los Angeles
Posted on: 04/4/2020

Support Engineer (Application programmer / Product Analyst)
Description: Hi, Hope you are doing well. Kindly share your updated resume if you are available for new project. Wishing you a great day. Position Support Engineer Application programmer Product Analyst Location (more...)
Company: JK Technosoft
Location: Los Angeles
Posted on: 04/4/2020

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Thousand Oaks RSS job feeds