Associate Manufacturing
Amgen
Summary
In this vital role you will collaborate with multiple functions within the Thousand Oaks site on a routine basis in a dynamic environment (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering, etc.) while developing a deep understanding of the manufacturing operations and planning activities within the facility.
Job description
What you will do
In this vital role you will collaborate with multiple functions within the Thousand Oaks site on a routine basis in a dynamic environment (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering, etc.) while developing a deep understanding of the manufacturing operations and planning activities within the facility.
Responsibilities of the role include:
- Executing drug product filling activities, respectively
- Performing initial review of manufacturing batch records
- Maintaining a safe and compliant culture by identifying preventative measures
- Creating and/or revising standard operating procedures
- Leading continuous improvement initiatives, which may be cross-functional in nature
- Performing data analysis (e.g., SPC, CPV) of critical process parameters and making recommendations to Engineering and/or Process Development teams
- Developing finite schedule for tasks including, but not limited to unit operations
- Monitoring productivity and identifying countermeasures for issues impacting cycle time adherence
- Elevating critical and impactful events to management
- Applying appropriate systems for job duties (SAP, QMTS, and LIMS etc.)
- Supporting the introduction of new products and technologies into the facility
- Initiating and owning quality records, including but not limited to non-conformances (NC), Corrective/Preventative Actions (CAPA)
Basic Qualifications:
- Bachelor's degree OR
- Associate's + 6 months of Manufacturing and/or Operations work experience OR
- High school/GED + 2 years of Manufacturing and/or Operations work experience
Preferred Qualifications:
- B.S. in a life science or related field
- 2 years of work experience in a GMP environment
- Ability to perform computer operations, such as ability to navigate in MS Office and Excel
- Ability to operate specialized equipment and computers as appropriate to the individual area
- Ability to adhere to regulatory requirements, written procedures and safety guidelines
- Ability to evaluate documentation/data according to company and regulatory guidelines
- Ability to interact with inspectors (internal and external)
- Technical writing capabilities
- Ability to organize work, handle multiple priorities and meet deadlines
- Demonstrated written and oral communication skills
- Presentation capabilities
- Detail oriented as well as flexible and adaptable to changing priorities and requirements
Requirements
- Bachelor's degree OR Associate's degree + 6 months of Manufacturing and/or Operations work experience OR High school/GED + 2 years of Manufacturing and/or Operations work experience
- B.S. in a life science or related field (preferred)
- 2 years of work experience in a GMP environment (preferred)
- Ability to perform computer operations, such as navigating MS Office and Excel (preferred)
- Ability to operate specialized equipment and computers (preferred)
- Ability to adhere to regulatory requirements, written procedures and safety guidelines (preferred)
- Ability to evaluate documentation/data according to company and regulatory guidelines (preferred)
- Ability to interact with inspectors (internal and external) (preferred)
- Technical writing capabilities (preferred)
- Ability to organize work, handle multiple priorities and meet deadlines (preferred)
- Demonstrated written and oral communication skills (preferred)
- Presentation capabilities (preferred)
- Detail oriented and flexible/adaptable to changing priorities (preferred)
Benefits
- Retirement and Savings Plan
- Group Medical Coverage
- Dental Coverage
- Vision Coverage
- Life Insurance
- Disability Insurance
- Flexible Spending Accounts
- Discretionary Annual Bonus
- Stock-Based Long-Term Incentives
- Time-Off Plans
- Flexible Work Models
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.