Manager Manufacturing Programs - Thousand Oaks CA

Military Spouse Corporate Career Network•Thousand Oaks, CA

4d•Onsite

About The Position

The Manager Manufacturing Programs is part of Amgen’s Manufacturing Programs team within the drug substance supply organization. The team supports manufacturing through new product introduction; introduction of new technologies and equipment; continual improvement projects; the multiproduct facility operation program; CAPA and deviation investigations; and optimization and implementation of single-use technologies. The supported plants manufacture drug substances for clinical trials at all phases through commercial production. This experienced manager will lead a team of upstream manufacturing subject matter experts and oversee technical operations, projects, technology development, and characterization activities. The role involves collaborating to identify and implement corrective and preventive actions, as well as hands-on plant-floor work executing runs and experiments, using large-scale equipment, and analyzing and summarizing data. Additional work includes defining and documenting operating practices, maintaining accurate operational documentation, implementing area improvements, commissioning equipment, designing experiments, communicating findings, and participating in operations meetings.

Requirements

Experience managing people.
Experience managing projects.
Experience leading or performing technology development activities and characterization efforts.
Experience in drug substance technical operations.

Responsibilities

Lead a team of manufacturing specialists and upstream manufacturing subject matter experts.
Use strategic problem-solving skills and champion continual improvement.
Manage sophisticated projects using project management skills.
Lead operational readiness for new technologies, equipment, or processes, applying technical process, scientific, operational, and compliance knowledge along with project management skills.
Assess and advise on the process impact of changes.
Develop and own drug substance manufacturing processes and procedures.
Draft and revise GMP manufacturing documents, including SOPs and forms.
Draft and develop user requirements for new technologies.
Write validation protocols and reports supporting cleaning validation, equipment commissioning, qualification, and change management.
Apply process, scientific, operational, and compliance knowledge and analytical troubleshooting to support delivery of new technologies into the plant.
Handle quality records, including CCMS, CAPA, and deviations.
Work collaboratively to identify and implement corrective and preventive actions.
Execute runs and experiments on the plant floor, work with large-scale equipment, and analyze and summarize data findings.
Define and document operating practices, ensure documentation accurately reflects operations performed, implement area improvements, commission equipment, design experiments, communicate findings, and participate in operations meetings.