Process Development Associate - Biological and Structural Characterization

Amgen SA; Thousand Oaks (CA); On-site; USD 95,000 - 125,000; Full time

Job summary

Amgen in Thousand Oaks, CA seeks a Process Development Associate – Biological and Structural Characterization to advance potency methods and product characterization. You will develop analytical assays for release and stability, prepare investigative reports, and analyze data to support regulatory submissions.

You will collaborate with product development and quality teams, ensuring thorough documentation and efficient transfer of methods.

Qualifications

• Bachelor’s degree or higher in a life-science field or equivalent.
• Experience with cell culture and quantitative analysis of proteins.
• Experience with cell-based bioassay development and transfer.
• Knowledge of signal transduction, gene expression, and receptor binding.
• Excellent documentation and detail orientation.

Responsibilities

• Implement analytical potency methods for release, stability, and characterization.
• Prepare technical reports for investigations and regulatory submissions.
• Generate and analyze data to support product development and regulatory filings.
• Contribute to analytical development teams with data interpretation and documentation.

Skills

Cell culture

Cell biology techniques

Bioassay development

Signal transduction

Gene expression

Receptor binding

Fluorescent probes

Documentation skills

Automated liquid handling

Client orientation

Communication skills

Education

Bachelor’s degree

Associate’s degree + 2 years operations experience

High school diploma / GED + 4 years operations experience

Job description

Process Development Associate – Biological and Structural Characterization

What you will do

Let’s do this. Let’s change the world. In this vital role you will help make a lasting impact on the lives of patients.

• Implementing state‑of‑the‑art and fit‑for‑purpose analytical potency methods for: release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations
• Assisting in the preparation of technical reports for investigations, product and impurity characterization, and regulatory submissions
• Generating and analyzing analytical data to support: product development and regulatory submissions
• May contribute to critical analytical development teams (e.g., product and process development teams, product quality teams) by providing analytical updates, analytical documentation and data interpretation. Keeps current in analytical development field including literature and technology development. Supports 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 professional we seek is a leader with these qualifications.

Basic Qualifications:

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

Preferred Qualifications

• Expertise in cell culture, and cell biology techniques for quantitative determination of biological activity of proteins
• Experience in cell‑based bioassay development (characterization methods, qualification, validation, technical transfer)
• Experience with signal transduction, gene expression, receptor binding and fluorescent probe technologies
• 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 – communicate 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.

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 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.