Process Development Associate- Attribute Sciences

Amgen; Thousand Oaks (CA); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Stock-based long-term incentives

Flexible work models

Competitive health/dental/vision plans

Generous time-off programs

Job summary

Amgen’s Thousand Oaks site seeks a Process Development Associate in Attribute Sciences to support analytical method development and product characterization. You will perform HPLC/UPLC and MS studies, document results, and collaborate across PD to enable robust manufacturing processes.

The role emphasizes crossing analytical science with regulatory support, maintaining GMP practices, and contributing to a broad pipeline for biologics and therapeutics.

Qualifications

• Bachelor’s degree in a related field or equivalent scientific experience.
• Experience with analytical method development and product characterization preferred.
• Excellent written and verbal communication skills; ability to multitask and manage complex projects.

Responsibilities

• Perform method development and qualification studies using HPLC, UPLC, and Capillary Electrophoresis.
• Conduct LC-MS studies for product characterization and comparability.
• Document results in notebooks and reports; transfer methods to Quality Control.
• Maintain and support GMP-compliant environment in the Attribute Sciences group.
• Collaborate with other PD teams to support process development and validation studies.

Skills

HPLC/UPLC

Mass spectrometry (MS)

Analytical method development

Team collaboration

Documentation

Education

Bachelor’s degree

Associate’s degree + 2 years scientific experience

High school diploma / GED + 4 years scientific experience

Tools

Capillary Electrophoresis

LC-MS

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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- Attribute Sciences

What You Will Do

Let’s do this. Let’s change the world. Amgen is a leading biotechnology company with a mission to serve patients around the world. As a science-based, patient-focused organization, we discover and develop innovative therapies to treat serious illnesses. Amgen’s Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes innovative analytical tools to guide that development. The Pivotal PD organizations focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic biologic modalities, including (but not limited to) monoclonal and bispecific antibodies, bispecific T-cell engagers (“BiTEs”), live oncolytic viruses, and synthetic medicines. As a PD Associate, the candidate will participate in protein characterization studies to support regulatory filings using High Performance Liquid Chromatography (HPLC) / Ultra Performance Liquid Chromatography (UPLC) and mass spectrometry (MS). The candidate will also work to develop, qualify, and transfer analytical methods to Quality Control, and optimize and troubleshoot existing methods. They will collaborate with other process development departments to support commercial process development and process characterization studies in support of marketing applications. This position is located at our Thousand Oaks, CA site.

Key responsibilities

• Perform method development and qualification studies using HPLC, UPLC, and Capillary Electrophoresis platforms
• Perform chromatographic fractionation, peptide mapping, intact mass, and other 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
• With a 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
• Perform experiments to help answer questions from health authorities
• Collaborate with partner organizations during commercial process development, process characterization, and process validation studies to support marketing applications

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications

• Bachelor’s degree
• OR
• Associate’s degree and 2 years of Scientific experience
• OR
• High school diploma / GED and 4 years of Scientific experience

Preferred Qualifications

• Scientific background in method development and product characterization for therapeutic proteins
• Preferred Degree in Biochemistry, Analytical Chemistry, Protein Chemistry or related subject area
• Excellent written and verbal communication skills, ability to multitask, efficiently plan and follow through on complex projects
• A self-starter, and someone who values working in teams

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. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

Sponsorship

Sponsorship for this role is not guaranteed.

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.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.