Process Development Associate – Large Molecule Release Testing
Amgen
Summary
In this vital role you will be responsible for defining the critical quality attributes of Amgen’s therapies and advancing innovative analytical tools to support their development.
Job description
Within AS, the Large Molecule Release Testing (LMRT) team in the Pre-Pivotal Biologics Attribute Sciences function supports release and stability testing of toxicology and clinical batches in a phase-appropriate GMP environment. The LMRT team collaborates closely with cross-functional partners to support analytical method co-development, co-qualification, and method transfer activities.
Key responsibilities
- Cell culture maintenance, reagents/media/buffer preparation, and relevant support.
- Routine laboratory maintenance such as restocking, ordering, and assistance in safety actions and audit readiness.
- Performing cell-based assays, binding assays, ELISA and qPCR assays.
- Generating robust and reliable data, organizing and reporting data in a validated system under minimal direction.
- Supporting method hand-off and troubleshooting.
- Supporting critical reagents freezer inventory management through detailed manual counts and maintenance of inventory tracking records.
Basic Qualifications
Bachelor’s degree OR Associate’s degree and 2 years of Scientific experience OR High school diploma / GED and 4 years of Scientific experience.
Preferred Qualifications
- B.S. or M.S. Degree in Cell Biology, Molecular Biology, Biomedical Engineering, Biochemistry or related technical subject area.
- Demonstrated ability in the biotech industry, including but not limited to GxP regulations.
- Experience in cell culture, cell-based bioassay, binding assays, immunoassays, and qPCR.
- Experience developing, qualifying, and testing analytical methods.
- Excellent teamwork skills working in a fast-paced GMP environment.
- Excellent documentation skills, including an understanding of GxP requirements.
- Excellent communication (oral and written) skills and attention to detail.
Requirements
- Bachelor’s degree OR Associate’s degree and 2 years of Scientific experience OR High school diploma / GED and 4 years of Scientific experience
- B.S. or M.S. Degree in Cell Biology, Molecular Biology, Biomedical Engineering, Biochemistry or related technical subject area
- Demonstrated ability in the biotech industry, including but not limited to GxP regulations
- Experience in cell culture, cell-based bioassay, binding assays, immunoassays, and qPCR
- Experience developing, qualifying, and testing analytical methods
- Excellent teamwork skills working in a fast-paced GMP environment
- Excellent documentation skills, including an understanding of GxP requirements
- Excellent communication (oral and written) skills and attention to detail
Benefits
- Health Insurance
- Dental Coverage
- Vision Coverage
- Life Insurance
- Disability Insurance
- Retirement and Savings Plan
- Flexible Spending Accounts
- Annual Bonus Program
- Stock-Based Long-Term Incentives
- Paid Time-Off
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.