Process Development Senior Associate
Amgen
Summary
Join Amgen's Pre-Pivotal Biologics Attribute Sciences group in Thousand Oaks, California as a Senior Associate supporting analytical method development and product characterization to advance candidates from research to first-in-human clinical trials.
Job description
The successful candidate will contribute to Amgen's diverse early-stage portfolio of biotherapeutic modalities by providing technical expertise in HPLC, Capillary Electrophoresis (CE), and related analytical methods, while also leveraging AI, automation, and digital collaboration platforms to accelerate science, reduce cycle times, and improve consistency across programs.
Key Responsibilities
- Generate, analyze, and critically evaluate analytical data (LC, CE, mass spectrometry, and related methods).
- Support analytical method optimization, method verification, troubleshooting method related issues.
- Provide technical leadership and identify opportunities for automation to reduce manual, repetitive tasks.
- Actively contribute to process improvements, strategy development, and cross-functional partnerships that promote consistent and efficient practices across Pre-Pivotal Biologics.
- Increase utilization of AI tools and digital analytics platforms to improve efficiency and insight generation.
- Steward analytical deliverables with accuracy, compliance, and adherence to Good Documentation Practices (GDP).
- Maintain electronic notebook records of experimental data, participate in authoring of technical protocols and reports, and present results in internal meetings.
Basic Qualifications
- Master's degree OR
- Bachelor's degree and 2 years of Scientific experience OR
- Associate's degree and 4 years of Scientific experience OR
- High school diploma / GED and 6 years of Scientific experience
Preferred Qualifications
- 3+ years of experience in industrial analytical laboratories supporting characterization of protein therapeutics
- Advanced technical expertise in analytical methodologies used to characterize protein therapeutics including CE, SEC, IEX, RP and HILIC, with good understanding both theoretical and practical aspects of stability-indicating assay, e.g., design, performance, results, etc.
- Strong analytical thinking, problem-solving, and troubleshooting skills.
- Excellent written and verbal communication skills for presenting scientific results in a fast-paced, multi-disciplinary environment.
- Proven ability to work effectively in collaborative, team-based settings.
- Attention to detail, compliance with GDP, and ability to adapt to dynamic priorities.
- A proactive, curious, and innovative mindset, with enthusiasm for applying digital solutions to scientific challenges.
Requirements
- Master's degree OR Bachelor's degree and 2 years of Scientific experience OR Associate's degree and 4 years of Scientific experience OR High school diploma / GED and 6 years of Scientific experience
- 3+ years of experience in industrial analytical laboratories supporting characterization of protein therapeutics
- Advanced technical expertise in analytical methodologies used to characterize protein therapeutics including CE, SEC, IEX, RP and HILIC
- Good understanding of theoretical and practical aspects of stability-indicating assay
- Strong analytical thinking, problem-solving, and troubleshooting skills
- Excellent written and verbal communication skills
- Proven ability to work effectively in collaborative, team-based settings
- Attention to detail, compliance with GDP, and ability to adapt to dynamic priorities
- Proactive, curious, and innovative mindset
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.