Senior Manager Manufacturing Systems (Drug Substance Automation)

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Job Description

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 illnessesdrives 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 awardwinning 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 daytoday 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 onsite work and rotational automation oncall 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 rightfirsttime (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 teams internal and external training needs.

• Responsible for ensuring the automation team actively participates in daily/weekly multifunctional 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:

• High school diploma / GED and 12 years of Engineering experience OR

• Associates degree and 10 years of Engineering experience OR

• Bachelors degree and 8 years of Engineering experience OR

• Masters degree and 6 years of Engineering experience OR

• Doctorate degree and 2 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 of 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 selfdirected team player ready to mentor and develop engineering staff and embrace a teambased culture that relies on collaboration for effective decisionmaking.

• Experienced in leading plant support team focused on troubleshooting ontime 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 wellbeing. 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 salesbased incentive plan

• Stockbased longterm incentives

• Awardwinning timeoff plans

• Flexible work models including remote and hybrid work arrangements where possible

Apply now and make a lasting impact with the Amgen team.

In any materials you submit you may redact or remove ageidentifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

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