Process Development Associate Scientist- Biological and Structural Characterization

Amgen; Cambridge (MA); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Discretionary annual bonus

Flexible work models

Job summary

Amgen in Cambridge, MA is seeking a Process Development Associate Scientist—Biological and Structural Characterization to develop, qualify, and transfer quantitative potency and biological assays, supporting sample testing and regulatory submissions.

You will work with analytical development teams, perform data analysis, contribute to method development and transfer projects, and help drive regulatory submissions with precise documentation, in a collaborative, science‑driven culture.

Qualifications

• Master’s degree and 1 year of scientific experience or Bachelor’s degree and 3 years of scientific experience.
• Preferred qualifications include cell biology, bioassay development and molecular biology techniques.

Responsibilities

• Develop, qualify and transfer quantitative potency and biological characterization assays.
• Support sample testing and regulatory submissions.
• Generate analytical data and provide updates to cross‑functional teams.
• Contribute to analytical development teams with documentation and interpretation.

Skills

Analytical method development

Data analysis

Transfer and qualification

Regulatory documentation

Education

Master’s degree

Bachelor’s degree

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, 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 Scientist—Biological and Structural Characterization

What You Will Do

In this vital role you will be responsible for developing, qualifying and transferring state‑of‑the‑art and fit‑for‑purpose quantitative potency and biological characterization assays and supporting sample testing and regulatory submissions.

• Implement state‑of‑the‑art and fit‑for‑purpose analytical potency methods for release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations.
• Assist in the preparation of technical reports for investigations, product and impurity characterization, and regulatory submissions.
• Generate and analyze analytical data to support product development and regulatory submissions.
• Contribute to critical analytical development teams (e.g., product and process development teams, product quality teams) by providing analytical updates, documentation, and data interpretation. Stay current in the analytical development field, including literature and technology development. Support analytical projects involving method development, qualification, and transfer.

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

• Master’s degree and 1 year of scientific experience.
• OR
• Bachelor’s degree and 3 years of scientific experience.

Preferred Qualifications

• Expertise in cell culture and cell biology techniques for quantitative determination of biological activity of proteins.
• Expertise in cell‑based bioassay development (characterization methods, qualification, validation, technical transfer).
• Expertise with signal transduction, gene expression, receptor binding and fluorescent probe technologies. Experience in molecular biology techniques to manipulate plasmid constructs for generation of transfected stable cell lines.
• Innovation—supports new ideas and initiatives.
• Detail‑oriented and excellent documentation skills.
• Experience with automated liquid handling preferred.
• Client orientation—establishes effective and responsive relationships with all clients; ensures value is delivered.
• Communication and interpersonal skills—communicates effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued, and understood; works well 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.

Benefits

• 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.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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.