Amgen Senior Manager Automation in Thousand Oaks, California

Job Summary

As a member of the Development Supply Chain Facilities and Engineering leadership team, the senior manager will provide leadership, strategy, and tactical direction for the automation department supporting the drug substance supply, drug product supply, packaging, and warehouse facilities at the Amgen Thousand Oaks Site. This position reports directly to the Facilities and Engineering head and will manage a dynamic team whose responsibilities include systems ownership, plant automation, and automation projects.

Key responsibilities include:

  • Ensure safety of all personnel during plant operations and engineering activities

  • Ensure that all staff are adequately trained and comply with all GMP standards and procedures

  • Maximize staff productivity and the efficient use of available resources

  • Maintain and improve plant capability and equipment reliability in partnership with plant leadership and other technical staff

  • Leverage resources to support ongoing capital project investment

  • Identify areas of potential improvement, conduct analyses, recommend solutions, sponsor improvement projects, and implement as required

  • Maintain and develop key performance indicators, supervise, assess, and develop staff, and ensure that all targets and milestones are completed on time and on budget

  • Interface with a diverse Amgen internal network including DSC clients (plant and area managers), Facilities & Engineering leadership, Capital Projects, Corporate Engineering, Global Facilities and Operations, and Environmental Health and Safety, Process Development, and other Commercial Sites.

Specific responsibilities include:

  • Oversee a safe and compliant work force working with a highly utilized clinical operations site

  • Oversee and execute complex and multi-layer related initiatives

  • Provide day-to-day, small project, and plant shut-down support

  • Work with a diverse group of clients, technologies, and integrated systems in product development and clinical operations, all in a GMP and highly regulated setting

  • Manage partners and drive new business processes to ensure continuous and sustained improvements

  • Ensure site readiness and compliance for internal audits, external agency audits, and partner visits

  • Coordinate business continuity

  • Present engineering plans, progress, and status updates to project stakeholders

  • Review and approve proposed engineering designs, and equipment improvements and changes

  • Perform administrative and oversight functions in approving proposals and expenditures

  • Participate in the development of capital expenditure requests

  • Interact with Global Amgen Network

Basic Qualifications:

Doctorate degree & 2 years of Operations or Manufacturing experience

OR

Master's degree & 6 years of Operations or Manufacturing experience

OR

Bachelor's degree & 8 years of Operations or Manufacturing experience

OR

Associate's degree & 10 years of Operations or Manufacturing experience

OR

High school diploma / GED & 12 years of Operations or Manufacturing experience

Preferred Qualifications :

  • 12+ years of relevant work experience with 8+ years' experience in an operations / manufacturing environment

  • 10+ years' experience with regulated environments (i.e. FDA/cGMP, OSHA, EPA)

  • Experience leading an automation department in a regulated GMP environment

  • Excellent organizational and administrative leadership skills

  • Experience using metrics to support process improvements

  • Ability to work and influence locally and across Amgen's network

  • Ability to work in a highly dynamic organization with a demanding environment

  • Demonstrated team motivation, leadership and mentoring/staff development skills

  • Understand regulatory trends in the industry. Direct experience with FDA or equivalent regulatory body

  • Ability to manage multiple resource demands and prioritization, assess project effectiveness, and efficiency and manage demand

  • Proven ability to transfer departmental strategy to staff and independently develop and implement business process improvements

  • Proven ability to motivate staff and establish and communicate visions/missions

  • Proven ability to delegate and manage the project work of others

Demonstrate a high degree of creativity, foresight and mature judgment in anticipating and solving problems

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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, or disability status.