Manager Manufacturing Programs

Amgen•Thousand Oaks, CA

13d

About The Position

The Manager Manufacturing Programs is part of Amgen’s Manufacturing Programs team within the drug substance supply organization. The team supports new product introductions, new technology and equipment introductions, continual improvement, multiproduct facility operations, CAPA and deviation investigations, and implementation and optimization of single-use technologies. The supported plants manufacture drug substances for clinical trials 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, plant-floor execution of runs and experiments, work with large-scale equipment, and analysis and communication of findings. The manager also defines and documents operating practices, ensures records accurately reflect work performed, improves operations, commissions equipment, develops experiments, and participates in operational meetings.

Requirements

One of the following education and experience combinations: doctorate degree; master’s degree and 3 years of manufacturing and operations experience; bachelor’s degree and 5 years of manufacturing and operations experience; 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 resource allocation. This experience may run concurrently with the required technical experience.
Availability to work various shifts, weekends, and holidays as instructed by the production schedule, including 5x8-hour or 4x10-hour schedules, to execute validation and project tasks with minimal disruption to operations.
Ability to work in a cleanroom wearing steel-toe shoes, full cleanroom gowning, a hairnet, and gloves while following GMP SOPs and adhering strictly to safety and compliance requirements.

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 a broad understanding of related disciplines.
Ability to communicate sophisticated technical information to internal and external colleagues at varying organizational levels through presentations and technical writing.
Ability to coach, mentor, and/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 steel 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.
Use strategic problem-solving and champion continual improvement.
Manage sophisticated projects using project management skills.
Lead operational readiness for new technologies, equipment, and processes, applying technical, scientific, operational, compliance, and project management knowledge.
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.
Collaborate with teams to identify and implement corrective and preventive actions.
Execute plant-floor runs and experiments, 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, and conduct design of experiments.
Communicate findings effectively and participate in operations meetings.