Process Development Senior Associate

Amgen•Thousand Oaks, CA

About The Position

Amgen’s Pre-Pivotal Biologics Attribute Sciences group in Thousand Oaks, California, is seeking a Senior Associate to support analytical method development and product characterization as candidates advance from research to first-in-human clinical trials. The role supports a diverse early-stage portfolio of biotherapeutic modalities and provides technical expertise in HPLC, capillary electrophoresis (CE), and related analytical methods. It also uses AI, automation, and digital collaboration platforms to accelerate science, reduce cycle times, and improve consistency across programs. The successful candidate will generate and evaluate analytical data, support method optimization and verification, troubleshoot analytical methods, and identify opportunities for automation and process improvement. The role also includes maintaining electronic notebook records, contributing to technical protocols and reports, and presenting results in internal meetings. Analytical deliverables must be accurate and compliant with Good Documentation Practices (GDP).

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.

Nice To Haves

3 or more 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, and a good understanding of theoretical and practical aspects of stability-indicating assays, including design, performance, and results.
Strong analytical thinking, problem-solving, and troubleshooting skills.
Excellent written and verbal communication skills for presenting scientific results in a fast-paced, multidisciplinary 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.

Responsibilities

Generate, analyze, and critically evaluate analytical data using LC, CE, mass spectrometry, and related methods.
Support analytical method optimization and method verification, and troubleshoot method-related issues.
Provide technical leadership and identify automation opportunities to reduce manual, repetitive tasks.
Contribute to process improvements, strategy development, and cross-functional partnerships that promote consistent and efficient practices across Pre-Pivotal Biologics.
Increase use of AI tools and digital analytics platforms to improve efficiency and insight generation.
Ensure analytical deliverables are accurate, compliant, and adhere to Good Documentation Practices (GDP).
Maintain electronic notebook records of experimental data.
Participate in authoring technical protocols and reports.
Present results in internal meetings.

Benefits

Health and welfare plans for staff and eligible dependents.
Financial plans with opportunities to save toward retirement or other goals.
Work/life balance and career development opportunities.
Comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions.
Group medical, dental, and vision coverage.
Life and disability insurance.
Flexible spending accounts.
Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
Stock-based long-term incentives.
Award-winning time-off plans.
Flexible work models where possible.