Process Development Associate Scientist
Amgen
Summary
In this vital role you will perform sample preparation, analytical testing, method development, and characterization using biophysical and spectroscopic techniques, including but not limited to Infrared (IR) spectroscopy, Circular Dichroism (CD) spectroscopy, UV-visible spectroscopy, and Differential Scanning Calorimetry (DSC) for thermal stability analysis. These activities will support product and process characterization and regulatory submissions. Experience with high-performance liquid chromatography (HPLC) for protein analysis is desired.
Job description
What you will do
In this vital role you will perform sample preparation, analytical testing, method development, and characterization using biophysical and spectroscopic techniques, including but not limited to Infrared (IR) spectroscopy, Circular Dichroism (CD) spectroscopy, UV-visible spectroscopy, and Differential Scanning Calorimetry (DSC) for thermal stability analysis. These activities will support product and process characterization and regulatory submissions. Experience with high-performance liquid chromatography (HPLC) for protein analysis is desired.
The associate will characterize higher-order structure (HOS) and aggregation-related attributes of biologics in support of product characterization, comparability and similarity studies, technology development, and non-routine investigations. Additional responsibilities will include sample preparation, complex data analysis and interpretation, trouble shooting, generation of technical reports and presentations, and development of acceptance criteria to support process development and comparability/similarity studies.
The position requires strong scientific and analytical skills, the ability to work collaboratively with scientists across multidisciplinary and cross-functional teams, and the flexibility to adapt to changing priorities in a fast-paced environment.
What we expect of you
Basic Qualifications:
- Bachelor's degree
- OR Associate's degree and 2 years of Chemistry, Biochemistry, Biotechnology, Physics, or related experience
- OR High school diploma / GED and 4 years of Chemistry, Biochemistry, Biotechnology, Physics, or related experience
Preferred Qualifications:
- Two or more years of experience directly related to the biophysical characterization of proteins, including hands-on experience with spectroscopic and biophysical techniques such as IR, CD, UV-visible spectroscopy, and DSC for thermal stability analysis.
- Hands-on experience with HPLC systems for the separation and characterization of proteins.
- Strong laboratory and analytical skills, including routine testing as well as the design and execution of scientific experiments, data analysis, interpretation of results, and maintenance of accurate laboratory records.
- Experience developing, qualifying, and/or validating analytical methods, analyzing and interpreting complex data, and establishing acceptance criteria to support product comparability and similarity studies.
- Demonstrated ability to collaborate effectively with scientists across multidisciplinary and cross-functional teams.
- Strong technical communication skills, including preparation of technical reports, scientific presentations, and documentation supporting regulatory activities.
- Ability to work independently, manage multiple priorities, and adapt effectively to evolving project needs and timelines.
Requirements
- Bachelor's degree OR Associate's degree and 2 years of Chemistry, Biochemistry, Biotechnology, Physics, or related experience OR High school diploma / GED and 4 years of Chemistry, Biochemistry, Biotechnology, Physics, or related experience
- Two or more years of experience directly related to the biophysical characterization of proteins
- Hands-on experience with spectroscopic and biophysical techniques such as IR, CD, UV-visible spectroscopy, and DSC for thermal stability analysis
- Hands-on experience with HPLC systems for the separation and characterization of proteins
- Strong laboratory and analytical skills
- Experience developing, qualifying, and/or validating analytical methods
- Demonstrated ability to collaborate effectively with scientists across multidisciplinary and cross-functional teams
- Strong technical communication skills
Benefits
- Health insurance
- Dental coverage
- Vision coverage
- Retirement and savings plan
- 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.