Process Development Associate
Amgen
Summary
Contribute towards Amgen's Drug Substance Process Development for late stage clinical and commercial biologics programs, including the development, characterization, and scale-up of upstream and downstream manufacturing processes supporting Ph II/III clinical trials to marketing application.
Job description
What you will do
Contribute towards Amgen's Drug Substance Process Development for late stage clinical and commercial biologics programs, including the development, characterization, and scale-up of upstream and downstream manufacturing processes supporting Ph II/III clinical trials to marketing application.
The Process Development Associate will help design and perform experiments at the bench scale that span the end-to-end Drug Substance process, from cell culture to purification operations.
- Contribute within a project team on goals such as improving process yield and robustness, and scaling-up processes to manufacturing sites
- Perform small-scale bioprocess experiments that encompass both upstream (cell culture) and downstream (purification) operations
- Cell culture responsibilities may include maintaining cultures in shake flasks, culture bags, and benchtop bioreactors
- Purification experiments include, but are not limited to, protein chromatography, filtration, and UF/DF operations
- Automation programming for benchtop bioreactors, chromatography systems, and robotic liquid handling systems
- Experimental design and data interpretation, leveraging in-house visualization and analytics tools
- Communication of findings through oral presentations and written documentation (technical reports as well as GMP documents to support regulatory filings)
- Provide scientific technical support for technology transfer of processes to manufacturing sites
Preferred Qualifications
- Bachelor's degree in Chemical, Biomedical, or related Engineering; Life Sciences; or other relevant sciences
- Experience and demonstrated interest in laboratory work, particularly hands-on experience with mammalian cell culture and/or purification operations
- Basic understanding of cell culture, protein chromatography, and filtration principles
- Demonstrated ability to identify and solve problems by applying scientific and engineering principles, preferably in a process development environment
- Strong communication and interpersonal skills, and the ability to work flexibly in a dynamic and collaborative environment with diverse team members
- Familiarity with design of experiments and statistical analysis of data
Requirements
- Bachelor's Degree
- Associate's degree and 2 years of Scientific experience
- High school diploma/GED and 4 years of Scientific experience
Benefits
- Retirement and Savings Plan
- Health insurance
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- 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.