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
Master's degree and 3 years of Manufacturing and/or Operations experience
Bachelor's degree and 5 years of Manufacturing and/or Operations experience
Associate's degree and 10 years of Manufacturing and/or Operations experience
High school diploma / GED and 12 years of Manufacturing and/or Operations experience
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
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: biochemistry, biology, biomaterials, biomechanics, biosynthetic, metabolic, msat, neurodegenerative, pain, pathogenesis