Manufacturing Specialist (Hope Valley)
Employment Type: Full-Time
Job description (Manufacturing Specialist AR30)
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. Amgen's new plant, AR30, is responsible for drug substance manufacturing and release of Amgen's commercial product using innovative single use manufacturing platforms and technologies.
We are looking for a talented Manufacturing Specialist to joining the manufacturing technical support function, initially to help with startup operations for our Next Generation Bio-manufacturing plant.
This individual contributor position reports into the Senior Manager of the AR30 Manufacturing Support Team and interacts broadly across the site/plant to implement key business deliverables, quality initiatives, and continuous improvement projects
Key Responsibilities include (but not limited to):
- Provide data to support management evaluation of performance trends
- Provide subject matter expertise for area of responsibility/ownership
- 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 Buffer/Media Preparation, Cell Culture and/or Purification and drug substance filling processes and process improvements
- Support of front line managers through on the floor presence
- Own and author critical standard operating procedures and supporting documentation/training.
- Lead and/or support root cause investigations related to performance trends and formal deviations
- Support of product reintroductions
- Develop, implement and assess solutions for complex problems
- Anticipate risk and builds contingencies to help mitigate impact
- Participate in regulatory audits
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 degree and 10 years of Manufacturing and/or Operations experience
High school diploma / GED and 12 years of Manufacturing and/Or Operations experience Preferred Qualifications
- Single use technology experience
- Extensive experience defending approaches during regulatory audits
- Cell Culture Experience
- Purification experience
- Hands on experience facilitating problem solving and root cause investigations in a biotechnology environment
- 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
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.
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, bioengineering, biological engineer, biomedical, biosynthetic, medical, molecular, neuro, neuroscience, pathogenesis
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