ThousandOaksRecruiter Since 2001
the smart solution for Thousand Oaks jobs

Principal Engineer - Pivotal Drug Product Technologies

Company: Amgen
Location: Thousand Oaks
Posted on: March 22, 2020

Job Description:

As part of the Drug Product Technologies (DPT) group, the process development Principal Engineer will provide support for Amgen's biologics drug product and process design, commercialization and lifecycle management. The Principal Engineer will lead a team of engineers and scientists responsible for the technical aspects of Amgen's drug product and process development. In addition to performing process characterization and formulation studies, this role will also focus on development of tools that will enhance efficiency and robustness of our technical data packages.The Principal Engineer will operate in a fast-paced, matrixed environment and collaborate successfully with colleagues within DPT and cross-functionally to develop and operationalize lean study designs for process characterization, create and implement tools for data acquisition, analysis, and modelling, and improve operational efficiency via alignment of work across teams, and tailoring output to intended user requirements. This individual will work independently, leading projects and self-managing work packages with appropriate communication and escalation. The Principal Engineer will be driven to find efficient approaches to solve relevant problems and will thereby deliver value-adding and agile solutions to Amgen Process Development. This individual will need to stay current on the latest developments/trends in the industry and scientific community to foster innovation and to meet future business needs.This position requires (up to 10%) travel to domestic and international sitesKey Responsibilities:

  • Based on a comprehensive knowledge of process/product commercialization activities and in partnership with other subject matter experts, develop and operationalize business processes to improve the efficiency and harmonization of the organization, including but not limited to standardized study designs, prior knowledge assessments, lessons learned, template protocols/reports.
  • Measure the effectiveness and adherence to relevant business processes and report these to management.
  • Lead cross-functional drug product team(s) as needed.
  • Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of Investigational New Drug (IND) and marketing application submissions.
  • Actively utilize advanced IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis.
  • Influence the planning, design, execution, and documentation of laboratory studies related to drug product design, formulation development, and process development in support of commercialization and life cycle management.
  • Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements.
  • Deliver progress reports and presentations to ensure management awareness and engagement of the current status, progress, and future program and functional needs.
  • Coordinate and organize resources needed to complete tasks.Basic Qualifications:Doctorate degree and 2 years of Engineering and/or Operations experienceORMaster's degree and 6 years of Engineering and/or Operations experienceORBachelor's degree or and 8 years of Engineering and/or Operations experienceORAssociate's degree and 10 years of Engineering and/or Operations experienceORHigh school diploma / GED and 12 years of Engineering and/or Operations experiencePreferred Qualifications:
    • Advanced degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutics or related discipline
    • 10+ years relevant experience
    • Experience in designing drug product unit operations such as freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection
    • Experience leading multiple cross functional drug product teams and/or multiple technical transfers of drug product processes to commercial manufacturing sites
    • Strong skills in applying fundamental engineering and scientific principles to process design
    • Project management skills, including the ability to manage multiple projects and evaluate project resource requirements.
    • Demonstrated ability in providing leadership to multi-functional teams to advance complex projects to completion and influencing decisions
    • Experience in drug product manufacturing environment and knowledge of cGMPsJoin 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 , Principal Engineer - Pivotal Drug Product Technologies, IT / Software / Systems , 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 IT / Software / Systems Jobs


Sr. Principal Software Engineer (TS/SCI Clearance)
Description: At Northrop Grumman we develop cutting-edge technology that preserves freedom and advances human discovery. Our pioneering and inventive spirit has enabled us to be at the forefront of many technological (more...)
Company: Northrop Grumman
Location: Whittier
Posted on: 04/9/2020

Enterprise Sr. Principal Software Engineer
Description: Do you want to work at an international company with endless opportunities for growth and advancement Are you eager to join a trust-based, globally-connected team, where your contributions will define (more...)
Company: Northrop Grumman
Location: Redondo Beach
Posted on: 04/9/2020

Sr. Principal Software Engineer (TS/SCI Clearance)
Description: At Northrop Grumman we develop cutting-edge technology that preserves freedom and advances human discovery. Our pioneering and inventive spirit has enabled us to be at the forefront of many technological (more...)
Company: Northrop Grumman
Location: Buena Park
Posted on: 04/9/2020


Entry Level Software Engineer
Description: As a leader in recruiting emerging technology talent across the country, Revature is looking forward to hiring over 300 new Entry Level Software Engineers in the next 4 weeks. br One day someone is (more...)
Company: Revature
Location: Buena Park
Posted on: 04/9/2020

Sr. Principal Software Engineer (TS/SCI Clearance)
Description: At Northrop Grumman we develop cutting-edge technology that preserves freedom and advances human discovery. Our pioneering and inventive spirit has enabled us to be at the forefront of many technological (more...)
Company: Northrop Grumman
Location: Huntington Park
Posted on: 04/9/2020

Sr. Principal Software Engineer (TS/SCI Clearance)
Description: At Northrop Grumman we develop cutting-edge technology that preserves freedom and advances human discovery. Our pioneering and inventive spirit has enabled us to be at the forefront of many technological (more...)
Company: Northrop Grumman
Location: Paramount
Posted on: 04/9/2020

Java Engineer
Description: Software Guidance Assistance, Inc., SGA , is searching for an Java Engineer for a CONTRACT assignment with one of our premier financial services clients in Newport Beach, California. This position will (more...)
Company: Software Guidance & Assistance
Location: Newport Beach
Posted on: 04/9/2020

Sr. Principal Software Engineer (TS/SCI Clearance)
Description: At Northrop Grumman we develop cutting-edge technology that preserves freedom and advances human discovery. Our pioneering and inventive spirit has enabled us to be at the forefront of many technological (more...)
Company: Northrop Grumman
Location: La Mirada
Posted on: 04/9/2020

MSS Software Engineer
Description: Do you want to work at an international company with endless opportunities for growth and advancement Are you eager to join a trust-based, globally-connected team, where your contributions will define (more...)
Company: Northrop Grumman
Location: Redondo Beach
Posted on: 04/9/2020

Request a Mobile Signing Notary!
Description: Request a Mobile Signing Notary Certified Mobile Notary Service is our priority is in ensuring your success. There simply is no better choice for a loan signing company Certified Mobile Notary Services (more...)
Company: Certified Mobile Notary Service
Location: Carson
Posted on: 04/9/2020

Log In or Create An Account

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

Thousand Oaks RSS job feeds