Senior Associate Manufacturing (Oakland)
Compensation: $79,950.00 - $112,910.00 /year *
Employment Type: Full-Time
Job description (Senior Associate Manufacturing 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 Senior Associate Manufacturing 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
The initial focus of this role will be part of the AR30 startup team to prepare the facility for Operational Readiness. This includes and not limited to supporting manufacturing operations team, developing training, SOPs, electronic batch records, job hazards analysis, and standard work and, participating in commissioning and qualification of process equipment.
Under minimal supervision, the Senior Associate Manufacturing will support operations in the Manufacturing area. The Senior Associate Manufacturing will own, monitor and troubleshoot critical processes and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports such as deviations. Senior Associate Manufacturing may participate in cross-functional teams and represent the Cell Culture and/or Purification groups. Senior Associate Manufacturing will also have the responsibility of owning at a minimum: Unit operations, SOPs, CAPA's, Change controls and Deviations. In addition, Senior Associate Manufacturing will identify, recommend, and implement improvements related to routine floor operations in solution preparation, cell culture and purification.Basic Qualifications:
Bachelor's degree with 2 years of manufacturing experience
Associate degree and 6 years of Manufacturing or Operations experience
High School diploma/GED and 8 years of Manufacturing or Operations experience.Preferred Qualifications:
- Single use technology experience
- Cell Culture Experience
- Purification experience
- Regulatory knowledge and experience with regulatory audits
- Ability to interpret and apply GMP knowledge
- Hands on experience facilitating problem solving and root cause investigations in a biotechnology environment
- Mechanical expertise
- Knowledge of WIP lab equipment and computers, with LIMS access
- Basic statistical and mathematical skills
- Understanding of analytical methods for manufacturing area
- Ability to demonstrate technical writing capability
- Able to demonstrate project management skills and presentation skills
- Ability to understand, apply and evaluate basic chemistry, biology and physical principles
- Basic troubleshooting skills on Manufacturing equipment including single use equipment
- Experience with Delta V/MES
- Experience with lab equipment/testing
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: bio, biological engineer, biology, biomedical engineer, biosynthetic, fermentation, neurodegenerative, neuroscience, parenteral, pharmaceutical
* 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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