Manager Manufacturing Programs - Thousand Oaks CA

VetJobs•Thousand Oaks, CA

6d•$100,000•Onsite

About The Position

The Manager Manufacturing is part of Amgen’s Manufacturing Programs team in the drug substance supply organization. The team supports new product introductions, new technology and equipment introductions, continual improvement projects, multiproduct facility operations, CAPA and deviation investigations, and the optimization and implementation of single-use technologies. The manufacturing plants produce drug substances for clinical trials through commercial production. This role leads a team of subject matter experts in upstream manufacturing. It combines people and project leadership with technology development, characterization, hands-on plant-floor work, and data analysis. The manager works collaboratively to identify and implement corrective and preventive actions; define and document operating practices; ensure manufacturing documentation accurately reflects operations; implement area improvements; commission equipment; design experiments; communicate findings; and participate in operations meetings. The position also supports the operational readiness and delivery of new technologies, equipment, and processes in a GMP manufacturing environment.

Requirements

Meet one of the following education and manufacturing/operations experience combinations: doctorate degree; master’s degree and 3 years of manufacturing and operations experience; bachelor’s degree and 5 years; 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. Managerial experience may overlap with the required technical experience.
Availability to work various shifts, including day, swing, graveyard, weekends, and holidays, according to the production schedule; schedules may include 5x8-hour or 4x10-hour shifts.
Ability to work in a clean room wearing steel-toe shoes, full clean-room gowning, a hairnet, and gloves, while following GMP SOPs and strict safety and compliance requirements.

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 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, and/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 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.
Apply 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 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 supporting cleaning validation, equipment commissioning and qualification, and change management.
Troubleshoot and support the detailed delivery of new technologies into the plant.
Handle quality records, including CCMS, CAPA, and deviations.
Perform plant-floor runs and experiments using large-scale equipment; analyze and summarize findings.
Define and document operating practices, ensure documentation reflects operations performed, implement area improvements, commission equipment, design experiments, communicate findings, and participate in operations meetings.