Process Development Sr. Scientist

BioSpace; Thousand Oaks (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Comprehensive benefits package

Stock-based incentives

Flexible time-off plans

Flexible work models

Job summary

Amgen seeks a Process Development Senior Scientist to advance early-stage large-molecule programs by characterizing process and product properties and ensuring quality attributes across pipelines. You will lead analytical efforts, apply MS and chromatographic techniques, and drive regulatory-ready data packages.

You will collaborate with cross-functional teams, design experiments to understand attributes and stability, and support drug substance/product development and tech transfer, while

Qualifications

• PhD or equivalent with post‑doc experience preferred.
• Strong expertise in analytical method development, qualification, and troubleshooting.
• Experience with protein therapeutics characterization and quality attributes.
• Familiarity with GMP compliance and regulatory expectations.

Responsibilities

• Provide analytical leadership for early-stage programs.
• Design experiments to understand therapeutic protein attributes and stability.
• Apply analytical methods to characterize protein therapeutics and assess QA attributes.
• Evaluate method performance and support regulatory submissions and tech transfer.
• Stay current with emerging analytical technologies and adapt strategies.

Skills

Analytical chemistry

Biochemistry

Biophysics

Mass spectrometry

HPLC/UPLC

CE

Education

PhD in life sciences

PharmD

MD

Master's degree + 3 years life science experience

Bachelor's degree + 5 years life science experience

Tools

HPLC/UPLC

CE

Mass spectrometry

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Process Development Senior Scientist

What You Will Do

Lets do this. Lets change the world. In this vital role you will support Amgens diverse early-stage therapeutic portfolio by characterizing process and product properties of large-molecule drug candidates and assessing quality attributes of protein therapeutics across multiple pipeline areas. This role will provide analytical leadership for pre-pivotal programs and apply advanced analytical techniques to characterize novel modalities in development.

• Serves effectively as the Attribute Sciences representative on cross-functional project teams and collaborates effectively with scientists across multidisciplinary teams.
• Designs experiments to build a fundamental understanding of therapeutic protein attributes and stability characteristics.
• Applies advanced technical expertise in analytical methods to characterize protein therapeutics, including CE, SEC, IEX, RP, HILIC, and mass spectrometry, with strong understanding of the theoretical and practical aspects of stability-indicating assays, including design, performance, and data interpretation.
• Evaluates analytical method performance and reliability, including the impact of proposed method changes.
• Demonstrates deep understanding of product quality attributes, analytical approaches used to measure them, and strategies to ensure appropriate control.
• Supports drug substance and drug product process development, protein characterization, analytical data generation for regulatory submissions, and technology transfer activities.
• Authors regulatory documents and applies understanding of regulatory expectations for analytical methods, control strategies, stability strategies, and comparability.
• Stays current in the field and evaluates emerging analytical technologies.

What We Expect Of You

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

Basic Qualifications

Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]

OR

Masters degree and 3 years of directly related life science experience

OR

Bachelors degree and 5 years of directly related life science experience

Preferred Qualifications

• Ph.D. in analytical chemistry, biochemistry, biophysics, or a related life science field, with 2 years of industry experience.
• Strong expertise in developing, qualifying, and troubleshooting analytical methods using HPLC/UPLC, CE, mass spectrometry, and related technologies to characterize protein therapeutics.
• Proven experience in separation sciences, protein chemistry, and/or mass spectrometry.
• Strong laboratory skills, including experimental design and execution, complex data interpretation, and timely delivery of results.
• Familiarity with common therapeutic protein quality attributes, such as fragmentation, deamidation, oxidation, and partial reduction, as well as tools used for their characterization and quantification.
• Understanding of, or experience with, GMP compliance.
• Ability to work independently to advance projects and studies within required timelines.
• Excellent written and verbal communication skills, with the ability to document, present, and discuss scientific results in a fast-paced, multidisciplinary environment.

What you can expect from 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, well 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.

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.

Application deadline

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.

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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.