Amgen

Manager Manufacturing

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Feb 12, 2019
Ref
R-71054
Required Education
Associate Degree
Position Type
Full time
ATO building 23 is part of Amgen's Drug Substance Supply organization within Development Supply Chain. This organization is uniquely positioned within Amgen's Operations function to provide end-to-end clinical supply, process development and technology integration across the manufacturing network. This organization creates value by providing clinical products, development and product launch services and technology applications.

ATO building 23 bulk drug substance manufacturing facility is a multi-product, multi-host facility which delivers clinical, commercial and biosimilar drug substance products playing a vital role in Amgen's state-of-the-art biologics manufacturing network. Facility operations encompass new product introduction and technology development to clinical and commercial campaign production execution. This position offers the opportunity to collaborate with multiple functions within the Thousand Oaks site on a routine basis in a dynamic environment (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering, Regulatory Compliance, etc.) while developing a deep understanding of the manufacturing operations and planning activities within the facility and site.

The Manufacturing Manager is responsible for leading a team of experienced manufacturing associates and technicians responsible for Drug Substance operations, while championing a safe and compliant production environment through structured on-floor presence.

In this position, the manager will ensure production areas and procedures remain in compliance with current Good Manufacturing Practices, set and measure team performance/goals, contribute to production scheduling decisions, coordinate cleaning validation activities, work cross-functionally to close nonconformance investigations and implement new technologies.

Position will perform shift work (day, swing and graveshift) as dictated by business needs.
  • Participate as a role model in Lean culture and continuous improvement programs with responsibility to translate onto the manufacturing floor.
  • Staff selection, training, oversight, performance evaluations, and development. Ensures schedule adherence for tasks including but not limited to manufacturing, qualification, and maintenance activities.
  • Elevate critical and impactful events to Sr. management and make real time processing decisions. Ensures standard operating procedures are accurate for executing unit operations, batch record review is completed accurately meeting disposition timelines, and non-conformances are initiated & closed with right the first time documentation
  • Utilizes appropriate systems for job duties (SAP, QMTS, and LIMS etc.). Identifies and implements process and safety improvements. Communicate production floor and project work at different levels of management.
  • Interacts with business partners and internal/external audit teams including regulatory agencies as directed.
  • Interacts with business partners to assist with scheduling of maintenance tasks, engineering evaluations, quality control sample submission, and quality investigations.
  • Assists in the introduction of new products and technologies into the facility. Troubleshoot and perform initial assessment of events that have the potential to impact area safety and product quality.


Basic Qualifications

Doctorate degree

OR

Master's degree & 3 years of manufacturing and operations experience

OR

Bachelor's degree & 5 years of manufacturing and operations experience

OR

Associate's degree & 10 years of manufacturing and operations experience

OR

High school diploma / GED & 12 years of manufacturing and operations experience

Preferred Qualifications
  • Degree in Life Science, Chemistry, Engineering or Business
  • 5 years of related manufacturing experience
  • 3+ years of experience in a production Area Lead, Specialist or Manager role
  • Mechanical ability/expertise coupled with a solid understanding of Drug Substance p equipment
  • Ability to understand analytical methods in the manufacturing areas
  • Demonstrated technical writing ability and experience with continuous improvement methodologies
  • Demonstrated project management and presentation skills
Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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.

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