Senior Manager Manufacturing Systems; Drug Substance Automation

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Join to apply for the Senior Manager Manufacturing Systems (Drug Substance Automation) role at Bio Space

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnesses drives all that we do.

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnesses drives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Manager Manufacturing Systems (Drug Substance Automation)

What You Will Do

Lets do this! Lets change the world!

Responsibilities

In this role, the Senior Manager is responsible for providing technical and administrative leadership to a group of Automation Engineers accountable for Plant operational support and maintaining automation systems for the GMP Clinical and Commercial Drug Substance Plant Operations at Amgen Thousand Oaks (ATO). This role is expected to provide leadership as follows:

• Lead a team of automation professionals and serve as the main point of contact for automation function for Drug Substance Supply manufacturing.
• Define, drive, and deliver the automation and process control strategies within Drug substance manufacturing.
• Serve as an experienced advisor to senior level management and ensure the automation solutions & strategy development aligns with Manufacturing Process requirements.
• Strategic and tactical management and leadership in providing 24x7 day-to-day operational support and capital project support.
• Develop the scope and life cycle upgrade plan in partnership with OEM, Manufacturing & Amgen Operations Digital Transformation and Innovation (DTI) teams.
• Work with diverse groups (Manufacturing, Quality, Process Development, DTI, Safety, Global Engineering) and drive new business processes to ensure continuous and sustained automation improvement initiatives. Translate business needs into engineering technology solutions. Lead analysis of alternatives and recommendations for technical/business cases and subsequent implementation.
• Ensure plant readiness and quality and regulatory compliance for internal audits, external agency audits, and partner audits for the automation systems.
• Ensure the safety of all personnel during plant operations, maintenance, and project implementation activities.
• Develop expense budget forecasts and adhere to the budgeted expenses.
• Responsible for Staff Management for on-site work and rotational automation on-call support planning and execution.
• Prepare and communicate plant automation highlights and lowlights on a weekly basis to the key collaborators.
• Ensure Amgen Enterprise cyber resiliency compliance is maintained at 100%.
• Responsible for ensuring that the operational functionalities for each process unit operation, cleaning & sterilization systems are configured accurately in the automation systems in line with Process Transfer Documents.
• Develop, maintain and implement preventive maintenance activities with the team for all automation assets supporting Drug Substance Supply operations.
• Responsible for periodically assessing and ensuring sufficient spare parts for the Drug Substance Manufacturing & utilities automation systems are maintained within the Central Inventory.
• Ensure the right processes/systems are in place to capture 100% quality compliance for the right-first-time (RFT) delivery of automation solutions.
• Ensure that Electronic Reporting functionality is incorporated for all Drug Substance unit operations for production Batch records, cleaning, and sterilization systems, including Audit trail and version control.
• Responsible for ensuring service contracts with all OEMs & Integrated Service Providers are established for automation engineering service and support needs.
• Responsible for designing, developing, deploying, maintaining, and performing backup & restoration of manufacturing process control systems, automation, and field instrumentation technologies.
• Responsible for…