Sr. Scientist- PKDM-BA (Immunoassay)
Amgen
Summary
Amgen is seeking a motivated and scientifically rigorous Senior Scientist – Non-Regulated Immunoassays to join the PKDM organization at our Thousand Oaks, California site. This position will support biologics programs through the development, qualification, validation, and execution of non-regulated immunoassays used for pharmacokinetic and soluble target protein measurements.
Job description
Responsibilities Include:
- Develop, optimize, qualify, validate, and execute non-regulated immunoassays supporting pharmacokinetic and soluble target protein measurements.
- Perform sample analysis using a variety of immunoassay platforms including ELISA, MSD/ECL, Gyrolab, Quanterix, AlphaLISA, and other relevant technologies.
- Independently design experiments, analyze results, troubleshoot technical issues, and implement assay improvements.
- Generate high-quality, reproducible data while adhering to established scientific standards and laboratory procedures.
- Perform assay transfer, method qualification, and validation activities as required to support program objectives.
- Analyze and interpret experimental results and communicate findings through technical reports, presentations, and team discussions.
- Collaborate with scientists across Discovery Research, Precision Medicine, Translational Safety and Risk Sciences, and other functional areas.
- Maintain accurate laboratory records, experimental documentation, and data management practices.
- Contribute to evaluation and implementation of new immunoassay technologies and methodologies.
- Support laboratory operations including instrument maintenance, reagent qualification, inventory management, and continuous process improvements.
Basic Qualifications:
- Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] OR Master’s degree and 3 years of scientific experience OR Bachelor’s degree and 5 years of scientific experience
Preferred Qualifications:
- Master's degree in Immunology, Biochemistry, Bioanalytical Sciences, Pharmaceutical Sciences, or related scientific discipline
- 3–5 years of industry or contract research organization experience in immunoassay development and bioanalysis
- Demonstrated experience developing, qualifying, validating, and executing non-regulated immunoassays
- Strong hands-on expertise with immunoassay platforms including ELISA, MSD/ECL, Gyrolab, Quanterix, AlphaLISA, or related technologies
- Experience supporting pharmacokinetic and soluble target protein measurements for biologics programs
- Proven ability to independently conduct laboratory experiments, troubleshoot assay performance issues, and analyze complex datasets
- Strong understanding of immunoassay principles, assay optimization, and bioanalytical best practices
- Experience performing sample analysis and generating high-quality bioanalytical data in a regulated or non-regulated research environment
- Excellent organizational skills and attention to detail
- Strong written and verbal communication skills, including technical report writing and presentation of scientific results
- Demonstrated ability to work effectively in cross-functional teams and manage multiple priorities
Requirements
- Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] OR Master’s degree and 3 years of scientific experience OR Bachelor’s degree and 5 years of scientific experience
- Master's degree in Immunology, Biochemistry, Bioanalytical Sciences, Pharmaceutical Sciences, or related scientific discipline
- 3–5 years of industry or contract research organization experience in immunoassay development and bioanalysis
- Demonstrated experience developing, qualifying, validating, and executing non-regulated immunoassays
- Strong hands-on expertise with immunoassay platforms including ELISA, MSD/ECL, Gyrolab, Quanterix, AlphaLISA, or related technologies
- Experience supporting pharmacokinetic and soluble target protein measurements for biologics programs
- Proven ability to independently conduct laboratory experiments, troubleshoot assay performance issues, and analyze complex datasets
- Strong understanding of immunoassay principles, assay optimization, and bioanalytical best practices
- Experience performing sample analysis and generating high-quality bioanalytical data in a regulated or non-regulated research environment
- Excellent organizational skills and attention to detail
- Strong written and verbal communication skills, including technical report writing and presentation of scientific results
- Demonstrated ability to work effectively in cross-functional teams and manage multiple priorities
Benefits
- Health insurance
- Dental coverage
- Vision coverage
- Retirement and savings plan
- Life insurance
- Disability insurance
- Flexible spending accounts
- Discretionary annual bonus
- 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.