Process Development Associate – Large Molecule Release Testing

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. 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 Large Molecule Release Testing

What you will do

Lets do this! Lets change the world!

Amgens Attribute Sciences (AS) department within the Process Development (PD) organization is responsible for defining the critical quality attributes of Amgens therapies and advancing innovative analytical tools to support their development.

Within AS the Large Molecule Release Testing (LMRT) team in the Pre-Pivotal Biologics Attribute Sciences function supports release and stability testing of toxicology and clinical batches in a phase-appropriate GMP environment. The LMRT team collaborates closely with cross-functional partners to support analytical method co-development co-qualification and method transfer activities.

Key responsibilities for the PD Associate role include:

• Cell culture maintenance reagents/media/buffer preparation and relevant support.

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

• Performing cell-based assays binding assays ELISA and qPCR assays etc.

• Generating robust and reliable data organizing and reporting data in a validated system under minimal direction.

• Supporting method hand-off and troubleshooting.

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

• Managing critical reagent extensions by reviewing monthly needs submitting requests with supporting assay data and updating COA.

• 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 lab-based professional we seek is a scientist with the following qualifications.

Basic Qualifications:

• High school diploma / GED and 4 years of Scientific experience OR

• Associates degree and 2 years of Scientific experience OR

• Bachelors degree

Preferred Qualifications:

• B.S. or M.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 cell culture cell-based bioassay immunoassays and qPCR etc.

• 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 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.

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

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.

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.