Senior Manager Manufacturing Systems (Drug Substance Automation)

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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. 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 ultrafiltration/diafiltration, 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 engineering management professional we seek will possess these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of Engineering experience

OR

Masters degree and 6 years of Engineering experience

OR

Bachelors degree and 8 years of Engineering experience

OR

Associate degree and 10 years of Engineering experience

Or

High school diploma / GED and 12 years of Engineering experience.

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• Degree in Chemical Engineering or Electrical Engineering.
• 10+ years of relevant work experience in Life Science Manufacturing with a major focus on Process control and automation systems.
  • Emerson DeltaV Batch Distributed Control System (ISA Standard S88)
  • Rockwell Automation SCADA and PLC Platform.
  • Electronic Batch Reporting Systems Design and implementation
  • Process Control Network design including network segregation (ISA Standard S95)
  • Process Control Systems: Virtual Infrastructure design and implementation and ability to perform advanced troubleshooting activities
  • System Integration using Ethernet IP, OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies.
  • Compliance and regulatory requirements such as 21 CFR Part 11
• The ideal individual must be a self-directed team player ready to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.
• Experienced in leading plant support team focused on troubleshooting, on-time support, plant maintenance, system lifecycle management, Spare Parts management, and Service level agreements.
• Experienced in New Product Introduction to engineer automation systems to meet the process requirements.
• Experienced in talent management (recruit, train, retain and performance management)
• Experienced in managing internal and external communication with key stakeholders.
• Experienced in execution excellence to ensure Right the First Time (RFT) delivery of automation engineering services to the plant operations.

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, well 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:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now

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As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Location: Thousand Oaks, CA, US

Posted Date: 11/29/2024