Process Development Sr Associate

Amgen Inc.; Thousand Oaks (CA); Hybrid; USD 91,000 - 108,000; Full time

Benefits offered by this job

Stock options

Retirement plan

Medical, dental, vision coverage

Life and disability insurance

Annual bonus

Stock-based incentives

Flexible work models

Job summary

Amgen Inc. in Thousand Oaks, CA is seeking a Process Development Associate to advance analytical method development for protein analytics, including HPLC, UHPLC and CE workflows. You will collaborate with Attribute Sciences and Quality Control to transfer qualified methods and support product characterization in a GMP environment.

The role emphasizes data analysis, instrument troubleshooting, and cross-functional teamwork to drive scalable process development and regulatory readiness.

Qualifications

• Bachelor’s degree (or foreign equivalent) in Chemistry, Chemical Biology or related field with 2 years of related experience.
• Analytical chemistry experience for protein molecules and data/results analysis using Empower, Chromeleon & ChemStation.
• LC/LC-MS/CE analytics, method development and transfer experience.
• Method qualification and transfer for analytical instruments with data analysis and statistics.
• GLP standards and SOP implementation in a laboratory setting.
• Laboratory notebook documentation of experiments and results.

Responsibilities

• Perform method development and qualification studies using HPLC, UHPLC, and CE platforms.
• Perform chromatographic fractionation, peptide mapping, intact mass, and LC-MS studies for characterization.
• Author results in notebooks and lab reports; interface with QA to transfer methods.
• Maintain Attribute Sciences instruments and GMP-compliant environment.
• Evaluate critical quality attributes and coordinate identification studies.
• Conduct accelerated stability studies to define degradative pathways.
• Evaluate novel analytical technologies to drive innovation.
• Collaborate with partner organizations during process development and validation.

Skills

Analytical chemistry

Protein chemistry

Data analysis

Statistical evaluation

GLP compliance

Laboratory documentation

Instrument troubleshooting

Method development

Education

Bachelor’s degree in Chemistry, Chemical Biology or related field

Tools

Empower

Chromeleon

ChemStation

Waters instruments

Agilent instruments

SoloVPE

Job description

Career Category

Process Development

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Process Development Associate

Duties

• Perform method development and qualification studies using High Performance Liquid Chromatography (HPLC), Ultra-High Performance Liquid Chromatography (UHPLC), and Capillary Electrophoresis (CE) platforms
• Perform chromatographic fractionation, peptide mapping, intact mass, and other Liquid Chromatography – Mass Spectrometry (LC-MS) studies to support product characterization and comparability studies
• Author results in laboratory notebooks and method development reports, interfacing closely with Attribute Sciences Team Leads and Quality Control to transfer and troubleshoot qualified methods
• Participate in the maintenance of Attribute Sciences instruments and assist the Attribute Sciences department in maintaining a phase-appropriate good manufacturing practices (GMP) environment
• Focus toward evaluation of critical quality attributes, coordinate and perform attribute identification and characterization studies, including isolation and analysis of chromatography fractions
• Conduct and coordinate accelerated stability studies to define therapeutic degradative pathways
• Perform evaluation of novel platform analytical technologies to help drive innovation
• and Perform experiments to help answer questions from health authorities
• and Collaborate with partner organizations during commercial process development, process characterization, and process validation studies to support marketing applications

Requirements

• Bachelor’s degree (or foreign equivalent) in Chemistry, Chemical Biology or related field & 2 years of experience in the job offered or a research-related occupation
• Analytical chemistry experience for protein molecules, and completion of project deliverables including: designing and conducting degradation experiments, extracting and analyzing results via dedicated software: Empower, Chromeleon, and ChemStation;
• Liquid Chromatography principles, including the concepts of stationary and mobile phases, partitioning and separation based on different affinities;
• Analytical method development (chromatography and mass spectrometry), technologies and instrumentation including: High Performance Liquid Chromatography (HPLC), Liquid Chromatography – Mass Spectrometry (LC-MS), Solo Variable Pathlength Extension (SoloVPE), and Capillary Electrophoresis (CE);
• Method qualification and transfer for analytical instruments, along with data analysis and statistical evaluation of experimental results;
• Application analytical instrument troubleshooting across different platforms: Waters, Agilent, and Maurice;
• Analytical deliverables for pharmaceutical processes and product development;
• Data analysis, statistical analysis and method qualifications and transfers;
• Technical knowledge of proteins and peptides;
• Implementing Standard Operating Procedures in a laboratory environment in accordance with good laboratory practices (GLP) standards;
• Recording experimental conditions, results and observations in a laboratory notebook.

Job Details

Job type: Full-Time position. The annual salary range for this position in the U.S. is $91,125.00 - $108,296.00 per year. Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

Application notes

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Company culture & inclusion

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.