Senior Manager Manufacturing Systems (Drug Substance Automation)

Senior Manager Manufacturing Systems (Drug Substance Automation)

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's 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, you'll 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, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What You Will Do

Let's do this! Let's change the world!

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 Automation design, experience in process control engineering, and trouble shooting with GMP biopharmaceutical production facility equipment / systems such as media, harvest, bioreactors, chromatography, vial filtration, and integrating various OEM automation software.
• Responsible for leading continuous improvements resulting in enhanced safety, system reliability, and productivity (e.g., Cycle times, reduced plant utilities usage, etc.) related to Drug Substance Plant Operations.
• Lead / support technical root cause analysis, incident investigations, and trouble shooting process control issues related to plant operations.
• Responsible for ensuring that all the direct reports are adequately trained and follow all GMP standards and procedures by managing the team's internal and external training needs.
• Responsible for ensuring the automation team actively participates in daily / weekly multi-functional work center team meetings.
• Responsible for assessing manufacturing needs and developing plans for automation system expansion to support increased plant run rate.
• Mentor the staff for their career development.

What We Expect of You

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications :

Preferred Qualifications :

What You Can Expect of Us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work / life balance, and career development opportunities that may include :