Manufacturing Specialist Investigator

West Greenwich, RI, US
Oct 14, 2020
Required Education
High School or equivalent
Position Type
Full time
In support of Amgen's mission to serve patients, we are a diverse team working to continuously improve our clinical and commercial drug Substance Operations to ensure supply and to optimize the patient experience.

The Manufacturing Specialist Investigator conducts technical investigations from our clinical and commercial drug Substance Operations. Responsible to understand the investigation process as well as manufacturing processes for the Amgen Rhode Island Facility. The Manufacturing Specialist Investigator owns major and trend deviations to support identifying root cause and will also participate in multi-functional ideation of design solutions (CAPAs). Maintains close interaction with the Manufacturing leads, engineering, Process Development, Quality Controls, Supply Chain, and quality functions to mitigate product impact and contribute to product/process improvement.

  • Lead root cause analysis to identify the failure mode.
  • Identify root cause using tools such as fishbone diagrams, "5 Whys", KT, Process mapping, and risk assessments such as FMEA's or Fault Tree Analysis.
  • Applies knowledge and subject matter expertise to ensure end-to-end of investigations
  • Lead discussion to reduce, correct, mitigate and prevent the reoccurrence of the event based on output of root cause analysis.
  • Perform trend investigations, including statistical assessment of data to identify trends, as well as generation of reports.
  • Generate final technical reports, which may include data collection and statistical analysis of the data
  • Perform notification of potential product impact.
  • Advise management on investigation progress, product/ process risk, and potential delays.
  • Support functional management initiatives and objectives
  • Anticipates and prevents potential issues with regulators
  • Own and/or Drive Improvement projects/initiatives
  • Collaborate cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures.
  • Alert senior management of quality, compliance, supply and safety risks.

Basic Qualifications:
  • Doctorate degree
  • OR
  • Master's degree and 3 years of Manufacturing or Operations experience
  • OR
  • Bachelor's degree and 5 years of Manufacturing or Operations experience
  • OR
  • Associate's degree and 10 years of Manufacturing or Operations experience
  • OR
  • High school diploma / GED and 12 years of Manufacturing or Operations experience

Preferred Qualifications:
  • 5+ years of demonstrated ability in investigation process.
  • Strong technical writing
  • Proven Six Sigma proficiency specifically for root cause analysis methodology
  • Understanding and application of Drug Substance process, data mining, quality and compliance.
  • Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
  • Project Management experience
  • Able to influence tri-functional team and organizational leads

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.

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.