Process Development Associate – Large Molecule Release Testing, Pre-Pivotal Attribute Science

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

Benefits offered by this job

Retirement plan

Medical, dental and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock-based incentives

Time-off plans

Flexible work models where applicable

Job summary

Amgen is seeking a Process Development Associate – Large Molecule Release Testing, Pre-Pivotal Attribute Science in Thousand Oaks, CA. You will help define critical quality attributes and advance analytical tools to support development, release, and stability testing of therapies.

You will apply cGMP knowledge, assist in method transfer/qualification, and execute compendial methods along with chromatography and capillary electrophoresis.

Qualifications

• GxP regulatory experience and ability to work within regulatory expectations.
• Strong documentation skills and attention to detail.
• Experience with analytical method development and testing.
• Understanding of compendial techniques and chromatographic methods.

Responsibilities

• Define critical quality attributes and support analytical tool development for product release and stability.
• Provide technical support for method transfer, qualification, optimization, troubleshooting, and investigations in early phase GMP.
• Execute compendial methods and chromatography/CE methods for release testing and regulatory submissions.
• Document experiments per Good Documentation Practices; analyze and interpret analytical data.
• Collaborate with product development teams, quality groups and provide analytical updates.
• Perform routine lab tasks, restocking, ordering, safety actions, and audit readiness.
• Maintain monthly Work Order tracking for PM and calibration using Maximo.
• Manage reagents inventory and coordinate monthly pipette calibration; initiate investigations for out-of-tolerance results.

Skills

GxP regulations

Documentation skills

Communication skills

Attention to detail

Analytical method development

Education

Bachelor's degree

Associate's degree + 2 years operations experience

High school diploma / GED + 4 years operations experience

BS in Cell Biology, Molecular Biology, Biomedical Engineering, Biochemistry or related

Tools

Compendial techniques

Chromatography

Capillary electrophoresis

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.

Process Development Associate – Large Molecule Release Testing, Pre-Pivotal Attribute Science

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for defining the critical quality attributes of Amgen’s therapies and advancing innovative analytical tools to support their development.

• Good understanding of cGMP principles and follow compliance requirements in routine day to day work.

• Technical support of incoming methodtransfer/qualification,method optimization, troubleshooting method related issues, and investigations in an early phase GMP environment.

• Implementing and executing compendial methods (Protein conc, pH, Osmolarity, color, clarity etc), chromatography and capillary electrophoresis methods as part of the product release testing, stability testing, characterization, method optimization, investigations, and regulatory submissions

• Documenting all experiments following Good Documentation Practices. Generating, analyzing, and critical evaluation of analytical data to support product release and stability, process characterization, investigations, and regulatory submissions

• May participate or contribute to critical activities to support analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates, analytical documentation, and data interpretation

• Routine laboratory maintenance such as restocking, ordering, and assistance in safety actions and audit readiness.

• Maintaining and updating monthly Work Order (WO) tracking for PM and calibration activities using Maximo.

• Managing reagents freezer inventory through detailed manual counts and maintenance of inventory tracking records.

• Coordinating monthly pipette calibration, including collection, verification of WO closure, and initiation of HLEE investigations for out-of-tolerance results.

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
• Associate’s degree and 2 years of operations experience
• High school diploma / GED and 4 years of operations experience

Preferred Qualifications:

• B.S. Degree in Cell Biology, Molecular Biology, Biomedical Engineering, Biochemistry or related technical subject area

• Demonstrated ability in the biotech industry, including but not limited to GxP regulations.
• Experience in compendial techniques, chromatography and capillary electrophoresis techniques.
• Experience developing, qualifying, and testing analytical methods.
• Excellent documentation skills, including an understanding of GxP requirements.
• Excellent communication (oral and written) skills and attention to detail.

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.

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.