Manager Manufacturing - Thousand Oaks CA

Military Spouse Corporate Career Network•Thousand Oaks, CA

2d•Onsite

About The Position

Amgen is hiring a Manager Manufacturing for its Manufacturing Programs team in the drug substance supply organization. The team supports manufacturing through new product and technology introductions, equipment introductions, continual improvement projects, multiproduct facility operations, CAPA and deviation investigations, and implementation and optimization of single-use technologies. The supported plants manufacture drug substances for clinical trials and commercial production. The manager will lead a team of upstream manufacturing specialists and subject matter experts, managing people and projects and leading technology development and characterization activities. The role combines collaborative problem-solving and corrective and preventive action implementation with hands-on plant-floor work, including executing runs and experiments, using large-scale equipment, and analyzing and summarizing data. Other work includes defining and documenting operating practices, ensuring records reflect work performed, improving areas, commissioning equipment, designing experiments, communicating findings, and participating in operations meetings. The position leads operational readiness for new technologies, equipment, and processes; assesses process impacts of changes; develops and owns drug substance manufacturing processes and procedures; prepares and revises GMP documents; develops user requirements; and writes validation protocols and reports for cleaning validation, equipment commissioning, qualification, and change management. It also applies process, scientific, operational, compliance, and troubleshooting expertise to deliver new technologies into the plant and handles quality records, including CCMS, CAPA, and deviations. The role is on-site in Thousand Oaks, California. The schedule may vary according to production needs and project work.

Requirements

Doctorate degree; or master's degree and 3 years of manufacturing and operations experience; or bachelor's degree and 5 years; or associate's degree and 10 years; or high school diploma/GED and 12 years.
Experience directly managing people and/or leadership experience leading teams, projects, or programs, or directing resource allocation.
Experience in manufacturing and operations as specified by the applicable education pathway.
Ability to work in a clean room wearing steel-toe shoes, full cleanroom gowning, a hairnet, and gloves.
Ability to follow GMP documents and adhere strictly to safety and compliance requirements.
Availability to work various shifts and schedules, which may include day, swing, graveyard, weekends, holidays, 5x8-hour shifts, or 4x10-hour shifts, as directed by the production schedule.

Nice To Haves

Degree in engineering or life sciences.
Experience in GMP technical support, GMP operations, engineering, or process development.
Technical knowledge of drug substance processing and broad understanding of related disciplines.
Ability to communicate sophisticated technical information to colleagues at varying organizational levels through presentations and technical writing.
Ability to coach, mentor, or cross-train colleagues in a core technical area.
Ability to drive results through leadership of cross-functional teams.
Experience leading and managing projects and people.
Equipment and cleaning validation experience.
Understanding of stainless-steel and single-use technologies.
Excellent writing skills.
Presentation experience, including presentations to leadership or auditors.
Data analysis or data visualization skills.

Responsibilities

Lead a team of manufacturing specialists and upstream manufacturing subject matter experts.
Demonstrate strategic problem-solving and champion continual improvement.
Manage sophisticated projects using project-management skills.
Lead operational readiness for new technologies, equipment, and processes using technical, scientific, operational, compliance, and project-management knowledge.
Assess and advise on process impacts 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 for cleaning validation, equipment commissioning, qualification, and change management.
Troubleshoot and support delivery of new technologies into the plant.
Handle quality records, including CCMS, CAPA, and deviations.
Perform plant-floor runs and experiments, work with large-scale equipment, and analyze and summarize findings.
Define and document operating practices, ensure documentation accurately reflects operations, implement area improvements, commission equipment, design experiments, communicate findings, and participate in operations meetings.
Work shifts and schedules as instructed by the production schedule to execute validation and project tasks with minimal disruption to operations.