
Posted 10 days ago
Process Development Sr Associate - Attribute Sciences
Amgen
Requirements
High school diploma + 6 years experience, Associate's degree + 4 years experience, Bachelor's degree + 2 years experience, Master's degree, Analytical testing expertise, Method transfer and validation, GMP knowledge, Technical writing
Skills
ELISAqPCRGMPAnalytical Chemistry
About the role
Responsibilities
- Provide scientific and technical contributions within the Process Development Attribute Sciences department.
- Perform rapid and robust analytical testing to support the site, process development team, manufacturing, and quality control.
- Support small-scale model transfers, method transfers, investigations, and continuous improvement initiatives.
- Utilize analytical methodologies such as ELISA, qPCR, and UV-Vis spectrophotometry to detect product quality attributes and impurities.
- Execute analytical methods, author technical reports, and ensure strict compliance with safety and regulatory standards.
- Collaborate closely with Drug Substance, Quality, and Manufacturing functions.
Requirements
- High school diploma/GED with 6 years of related experience, OR
- Associate’s degree with 4 years of related experience, OR
- Bachelor’s degree with 2 years of related experience, OR
- Master’s degree.
- Expertise in analytical testing and technical writing.
- Knowledge of GMP requirements.
Preferred Qualifications
- Degree in Analytical Chemistry, Biochemistry, or a related scientific field.
- Experience in pharmaceutical process development and investigational testing.
- Proficiency with analytical techniques including ELISA, qPCR, and SoloVPE.
- Experience with method transfer, validation, and troubleshooting.
- Familiarity with USP monographs and ICH guidance documents.
- Strong ability to work in collaborative, cross-functional team settings.
Benefits
- Comprehensive health and welfare plans, including medical, dental, and vision coverage.
- Retirement and Savings Plan with company contributions.
- Discretionary annual bonus program and stock-based long-term incentives.
- Award-winning time-off plans.
- Opportunities for professional and career development.
About the Company
Amgen is a leading biotechnology company dedicated to serving patients living with serious illnesses. Since 1980, we have pioneered advancements in oncology, inflammation, general medicine, and rare diseases. Our mission is to unlock the potential of biology to deliver innovative medicines that help people live longer, fuller, and happier lives.
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Amgen · Holly Springs
