Sr Engineer Global Mfg Sciences & Tech, Process Development
As part of Amgen's Process Development organization, Global Manufacturing Sciences and Technologies provides regional expert technical support focused on delivering high quality product to patients through excellence in process support, process engineering and technology advancement and implementation. This position is located at our Cambridge, MA site.
*The Senior Engineer provides process development technical support to solid and liquid oral drug products at Amgen contracted manufacturing sites, including process performance, implementation of process improvement strategies, and development of process models.
*Leads and participates in formulation development and scale-up of oral solid and liquid dosage form formulations.
*Works with oral solid dose processes such as granulation, roller compaction, blending, milling, drying, compression, and encapsulation.
*The successful candidate will act as a drug product contract manufacturing and team leader to provide process leadership and solve process challenges across multiple unit operations. Provide process development expertise for commercial drug product processing in specific areas such as process characterization, tech transfer and validation.
*Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA, process characterization, scale up, validation, and technology transfer.
*Troubleshoot issues with drug product processing technologies and equipment; develop and characterize drug product processes and transfer technology to commercial drug product sites; conduct risk assessment for drug product operations and propose / implement appropriate CAPA; identify and implement operational opportunities for current and new sterile operations.
Responsibilities may also include leading cross-site teams to support the above activities, providing recommendations to management.
Travel (up to 25%) to domestic and/or to international contract manufacturing sites is expected
Master's Degree and 3 years of Engineering and/or Operations experience
Bachelor's Degree and 5 years of Engineering and/or Operations experience
Associate's degree and 10 years of Engineering and/or Operations experience
High school diploma/GED and 12 years of Engineering and/or Operations experience
-M.S. in Science or Chemical Engineering
-6 years of experience in support of commercial oral solid and liquid Drug Product (DP) processing in specific areas such as Process Characterization, Tech Transfer (to commercial DP sites) or Validation.
-Strong skills in applying fundamental engineering and scientific principles to the design and implementation of granulation, roller compaction, blending, milling, drying, compression, and encapsulation processes.
-Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
-Experience working with external contractors/suppliers with demonstrated use of interpersonal skills to build strong technical relationships.
-Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
-Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.
-Experience with parental fill finish operations including drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation, for protein parenteral products.
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 leverages 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.