Process Development Associate - Biological and Structural Characterization

BioSpace; Thousand Oaks (CA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Comprehensive benefits package

Bonus program

Stock-based incentives

Generous time-off plans

Flexible work models

Job summary

Amgen is seeking a Process Development Associate in the Biological and Structural Characterization stream to advance our therapeutics pipeline. You will implement analytical potency methods and contribute to investigations, regulatory submissions, and data interpretation, supporting product development efforts in a collaborative, science-driven environment.

Ideal candidates will have a Bachelor’s degree and experience in cell culture, bioassay development, and analytical methods, with strong

Qualifications

• Bachelors degree required or equivalent combination of education and experience.
• Experience in cell culture and bioassay development is preferred.
• Strong documentation and data interpretation skills are essential.
• Familiarity with signaling pathways and fluorescent probe technologies is desirable.
• Ability to work effectively in cross-functional teams and maintain meticulous records.

Responsibilities

• Implement analytical potency methods for release, stability, and product characterization.
• Assist in preparing technical reports for investigations and regulatory submissions.
• Generate and analyze analytical data to support product development and regulatory filings.
• Contribute to analytical development teams with method development, qualification and transfer.

Skills

Cell culture

Cell biology techniques

Bioassay development

Analytical data interpretation

Documentation skills

Education

Bachelor's degree

Associates degree + 2 years operations experience

High school diploma / GED + 4 years operations experience

Tools

Automated Liquid Handling

Job description

Basic Qualifications

Bachelors degree

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 Associate Biological and Structural Characterization

What you will do

Lets do this. Lets 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

• Bachelors degree
• OR
• Associates 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, 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.

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.