• Amgen
  • Clayville , RI
  • Engineering
  • Full-Time
  • 295 Field Hill Rd

Amgen Rhode Island is one of the premier biologics drug substance manufacturing sites in the world with a long history of operational excellence and highly successful commercial and clinical operations.
We are looking for a talented Manufacturing Specialist to help deliver opportunities for reliability, efficiency, agility and differentiation for the AR5 Manufacturing plant.

This individual contributor position reports into the Director of Manufacturing (Downstream), and interacts broadly across the site to implement key business deliverables, quality initiatives, and continuous improvement projects within the downstream area.

Key Responsibilities include:
  • Provide data to support management evaluation of performance trends
  • Provide subject matter expertise for area of responsibility
  • Own quality records (change control, CAPA, deviations) and deliver to timelines
  • Identify and autonomously implement continuous improvement opportunities
  • Creation of solid business cases for improvement ideas
  • Collaborate with Quality, Process Engineering, Regulatory, and Process Development to implement process improvements
  • Support of front line managers through on the floor presence
  • Own and author critical standard operating procedures and supporting documentation/training.
  • Review and approval of master batch records
  • Lead and/or support root cause investigations related to performance trends and formal deviations
  • Support of new product and product reintroductions
  • Develop, implement and assess solutions for complex problems
  • Anticipate risk and builds contingencies to help mitigate impact


Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years of Manufacturing and/or Operations experience

OR

Bachelor's degree and 5 years of Manufacturing and/or Operations experience

OR

Associate's degree and 10 years of Manufacturing and/or Operations experience

OR

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

Preferred Qualifications:
  • Hands on experience facilitating problem solving and root cause investigations in a biotechnology environment
  • Knowledge in the use of data analysis tools and use of software platforms such as TrackWise
  • Strong project management skills with ability to multi-task and function in a dynamic environment
  • Excellent communication skills, drive, and sense of urgency
  • Demonstrated ability to forge and maintain strong relationships within other functional areas
  • Ability to recommend, judge, and make good decisions in complex situations
  • Ability to tactfully and effectively negotiate and influence


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.
Associated topics: bio, biology, biomaterials, biomedical engineer, bioprocess, medical, neurodegenerative, pain, pharmaceutical, therapeutic

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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