Amgen

Manager Manufacturing

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Jun 06, 2019
Ref
R-77718
Required Education
High School or equivalent
Position Type
Full time
The Amgen Thousand Oaks, Building 20 Drug Product Manufacturing facility directly supports Amgen's pipeline of clinical drug product supply to patients across the globe. The Manager Manufacturing - Drug Product role 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.

You will be responsible for leading a team of experienced manufacturing associates and technicians within Drug Product operations, while championing a safe and compliant production environment through structured on-floor presence.

This position, 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, and work cross-functionally to close deviation investigations and introduce new product SKUs.

Responsibilities
  • Staff selection, training, oversight, performance evaluations, and development.
  • Schedule adherence for tasks including, but not limited to manufacturing, qualification, and maintenance activities.
  • Participating as a role model in Lean culture and continuous improvement programs with responsibility to translate onto the manufacturing floor.
  • Elevating critical and impactful events to senior management and make real time processing decisions.
  • Ensuring standard operating procedures are accurate for executing unit operations, batch record review is completed accurately, meeting disposition timelines, and deviations are initiated & closed with right the first-time documentation
  • Utilizing appropriate systems for job duties (SAP, QMTS, LIMS, etc.). Identifies and implements process and safety improvements. Communicate production floor and project work at different levels of management.
  • Interacting with business partners and internal/external audit teams including regulatory agencies as directed.
  • Interacting with business partners to assist with scheduling of maintenance tasks, engineering evaluations, and quality investigations.
  • Supporting 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.
  • Assessing departmental utilization to execute both near-term schedule and long-term strategy.


Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of drug product manufacturing or operations experience

OR

Bachelor's degree and 5 years of drug product manufacturing or operations experience

OR

Associate's degree and 10 years of drug product manufacturing or operations experience

OR

High school diploma / GED and 12 years of drug product manufacturing or operations experience

Preferred Qualifications
  • At least 5 years of bio-pharmaceutical experience, with 3 years of leadership experience directly within drug product manufacturing that includes aseptic and sterile filling environments
  • Bachelor's or Master's degree in Engineering, Microbiology, Life Sciences, Business or a related field
  • Experience with Component Preparation, Environmental Support, Lyophilization, Aseptic Filling within Isolators
  • Strong working knowledge of lean concepts and application within a regulated manufacturing environment
  • Effective at working in fast-paced environments, specifically in a leadership capacity to facilitate objective decision making


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.