Process Development Associate- Attribute Sciences

Amgen Inc. (IR); Thousand Oaks (CA); On-site; USD 75,000 - 101,000; Full time

Job summary

Amgen Inc. in Thousand Oaks, CA is seeking a Process Development Associate in Attribute Sciences to advance analytical methods for therapeutic proteins. You will perform HPLC/UPLC and MS analyses, develop and transfer methods to QC, and support GMP-compliant process development efforts.

The role requires a scientific background in method development, strong communication, and teamwork. Amgen offers competitive pay and robust benefits with opportunities for career growth within a global biotech

Qualifications

• Bachelor’s degree or Associate’s degree with 2 years of scientific experience.
• High school diploma / GED and 4 years of scientific experience.
• Scientific background in method development and product characterization is preferred.

Responsibilities

• Perform method development and qualification studies using HPLC, UPLC, and Capillary Electrophoresis.
• Conduct LC-MS studies to support product characterization and comparability studies.
• Document results in notebooks and development reports; transfer methods to Quality Control.
• Maintain PD instruments and support GMP environment within Attribute Sciences.
• Coordinate and perform attribute identification and characterization studies on chromatography fractions.
• Support accelerated stability studies to define therapeutic degradative pathways.
• Evaluate novel analytical technologies to drive innovation.
• Collaborate with cross-functional teams during process development and validation.

Skills

Communication skills

Team collaboration

Multitasking

Self-starter

Education

Bachelor’s degree

Associate’s degree

Tools

HPLC

UPLC

Mass spectrometry

Job description

Process Development Associate - Attribute Sciences

Career Category Scientific 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.

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
• 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.

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.

Sponsorship

Sponsorship for this role is not guaranteed.

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.

Equal Opportunity Employer

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.

Salary Range

74,503.35USD -100,798.65 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen