Manager Manufacturing Programs

Amgen•Thousand Oaks, CA

11d

About The Position

The Manager Manufacturing is part of Amgen’s Manufacturing Programs team within the drug substance supply organization. The team supports manufacturing through new product and technology introductions, equipment introduction, 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 from clinical-trial phases through commercial production. This role leads a team of upstream manufacturing specialists and subject matter experts. It combines people and project leadership with technical operations work, including technology development and characterization, corrective and preventive action implementation, and hands-on plant-floor execution of runs and experiments. The manager analyzes and summarizes data, defines and documents operating practices, ensures documentation reflects work performed, implements area improvements, commissions equipment, designs experiments, communicates findings, and participates in operations meetings. The role also supports operational readiness and delivery of new technologies into the plant while applying process, scientific, operational, and compliance knowledge.

Requirements

Doctorate degree; or master’s degree and 3 years of manufacturing and operations experience; or bachelor’s degree and 5 years of manufacturing and operations experience; or associate’s degree and 10 years of manufacturing and operations experience; or high school diploma/GED and 12 years of manufacturing and operations experience.
Experience directly managing people and/or leadership experience leading teams, projects, or programs, or directing allocation of resources, in addition to the applicable technical experience.
Availability to work various shifts and schedules as instructed by the production schedule, including weekends and holidays, to execute validation and project tasks with minimal disruption to operations.
Ability to work in a clean room wearing steel-toe shoes, full cleanroom gowning, a hairnet, and gloves, while following GMP documents and adhering strictly to safety and compliance.

Nice To Haves

Degree in engineering or life sciences.
Experience in GMP technical support roles, GMP operations, engineering, or process development.
Technical knowledge of drug substance processing and broad understanding of related disciplinary areas.
Ability to communicate sophisticated technical information to internal and external colleagues at varying organizational levels, through presentations and technical writing.
Ability to coach, mentor, or cross-train colleagues within 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 and single-use technologies.
Excellent writing skills and experience presenting to leadership or auditors.
Data analysis and/or data visualization skills.

Responsibilities

Lead a team of manufacturing specialists and upstream manufacturing subject matter experts.
Champion continual improvement and apply strategic problem-solving skills.
Manage sophisticated projects using project management skills.
Lead operational readiness for new technologies, equipment, or 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 detailed 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.
Perform plant-floor runs and experiments using large-scale equipment; analyze and summarize data 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.

Benefits

Retirement and Savings Plan with company contributions.
Medical, dental, and vision coverage.
Life and disability insurance.
Flexible spending accounts.
Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
Stock-based long-term incentives.
Time-off plans.
Flexible work models where possible.
Career development opportunities.
Work/life balance plans.