Process Development Sr. Engineer - Drug Product

As part of the Drug Product Technologies group, the process development Sr. Engineer will provide expert technical support to Amgen's internal and contract parenteral drug product clinical manufacturing sites. The candidate will play a key role in bringing a wide variety of high-quality clinical products to patients through excellence in process engineering, technology transfer, and clinical manufacturing support. This position is based in Thousand Oaks, CA.

The process development Sr. Engineer will provide process development technical support to parenteral drug product sterile fill finish manufacturing at Amgen's clinical manufacturing sites. The support will include aligning process design and characterization to clinical manufacturing capabilities, characterization of manufacturing equipment within products operating ranges, process performance monitoring, and implementation of process improvement strategies. The role also requires working in cross-functional teams to conduct risk assessment, non-conformance investigation and corrective actions discussions. In addition, the candidate will be responsible to support fill finish site expansion project(s), including defining equipment user requirement, factory acceptance tests, functional characterization and process performance qualification, with emphasis on the lyophilization unit operation.

Specific responsibilities:

• Acts as single point of contact to drug product teams to provide the clinical manufacturing site process capabilities and practices for all drug product manufacturing unit operations with an emphasis on lyophilization.
• Leads technology transfers of lyophilized drug products into clinical manufacturing sites, conducting make-a-batch exercises, process transfer documents, and change control PD assessments.
• Supports process improvements, integration of new equipment & technologies, scale-ups, NC/CAPA investigations, machinability/characterization/engineering runs and troubleshoots issue related to existing equipment.
• Conducts risk assessments for drug product operations and identify and implement operational opportunities for current and new sterile operations.
• Supports expansion projects by creating equipment user requirements, conducting FAT, process characterization and validation for sterile drug product fill and finish processes, specifically in lyophilization unit operation and equipment.
• Leading cross-functional teams to support activities and communicating/presenting outcomes to executive management as appropriate.

Travel (up to 20%) to domestic and/or to international contract manufacturing sites is desirable.

Basic Qualifications:

Doctorate Degree

OR

Master's Degree and 3 years of Engineering and/or Operations experience

OR

Bachelor's Degree and 5 years of Engineering and/or Operations experience

OR

Associate's degree and 10 years of Engineering and/or Operations experience

OR

High school diploma/GED and 12 years of Engineering and/or Operations experience

Preferred Qualifications:

• M.S. in Science or Chemical Engineering
• 6 + years of experience in support of Clinical or Commercial Parenteral Drug Product (DP) fill and finish processing with demonstrated strong understanding of the lyophilization unit operation
• Well versed in lyophilization principles, cycle development, scale-up, data acquisition and analysis
• Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, formulation, filtration and filling unit operations with emphasis on lyophilization
• Knowledge of protein biochemistry with regard to chemical and physical stability
• 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

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.