Process Development Senior Associate
Process Development Senior Associate
US - North Carolina - Holly Springs Apply NowHOW MIGHT YOU DEFY IMAGINATION?
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded Industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Process Development Senior Associate (Attribute Sciences)
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will work to provide scientific and technical contributions within Process Development Attribute Sciences at Amgen’s 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.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The collaborative professional we seek is a self-starter with these qualifications.
Basic Qualifications:
- Bachelor’s degree and 3 years of related experience OR
- Master’s degree and 1 year of related experience
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.
- Strong 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, method troubleshooting, and complex investigations.
- Familiarity with and understanding of 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.
- Knowledgeable in analytical method troubleshooting and analysis of product quality attributes related to biological processing.
- Oral and verbal communication skills, interact effectively with diverse internal and external stakeholders.
- Excellent technical writing skills and attention to details in documents.
- A self-starter and valuable teammate.
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply nowfor a career that defies imagination
Objects in your future are closer than they appear. Join us.
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Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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.
