Process Development Associate (Attribute Sciences)

Career Category

Job Description

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 (Attribute Sciences)

What you will do

Lets do this. Lets change the world. This role is part of Amgens Attribute Sciences (AS) department within the Process Development (PD) organization that defines the favorable quality characteristics of the therapies it produces and optimizes innovative analytical tools to guide that development.

In this vital role you will work to provide scientific and technical contributions within Process Development Attribute Sciences at Amgens FleX Batch facility. This laboratory-based role will evaluate attributes of materials based upon multiple analytical techniques focusing on analytical testing support and troubleshooting.

• Responsibilities include effectively delivering to the site process development team and quality control through rapid and robust analytical testing.
• Ensure analysis support for small-scale model transfer method transfers investigation support and continuous improvements
• Work closely with functions including but not limited to Drug Substance Quality and Manufacturing
• Understand analytical methodologies to detect product quality attributes and process-related impurities testing using a variety of techniques including but not limited to UV-Vis spectroscopy chromatography capillary electrophoresis and PCR.
• Execute methods author reports and ensure safety and compliance for all activities.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The vital attribute professional we seek is a type of person with these qualifications.

Basic Qualifications:

• High school diploma / GED and 4 years of Process Development / Chemistry or related experience OR
• Associates degree and 2 years of Process Development / Chemistry or related experience OR
• Bachelors degree

Preferred Qualifications:

• Degree in Chemistry or related area.
• Experience in pharmaceutical process development with related experience in analytical support execution of methods and investigational testing.
• Experience in single or multiple analytical techniques (i.e. CE (Capillary Electrophoresis) ELISA DNA Chromatography (SE and RP) PCR).
• Experience in method transfers method validation and method troubleshooting.
• Familiarity with United States Pharmacopeia (USP) monographs and chapters and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) mentorship documents related to analytical method transfer and validation.
• Effective oral and verbal communication skills.
• Technical writing skills and attention to details in documents.
• A self-starter and valuable teammate.

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.

In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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

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.

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