Job Information
Amgen Process Development Senior Scientist in Holly Springs, North Carolina
HOW 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 Scientist (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 optimally 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 and provide analytical support to 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
Support Amgen as a network by providing technical insight applying analytical expertise as needed
Provide expertise and evaluation of Amgen’s platform and analytical technologies, helping to drive innovation and efficiency within Process Development.
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 5 years of directly related experience OR
Master’s degree and 3 years of directly related experience OR
Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]
Preferred Qualifications:
Advanced degree in Analytical Chemistry or related area.
Four or more years of experience in pharmaceutical process development with related experience in analytical support, execution of methods, and investigational testing.
Strong and in-depth expertise in a 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 complex method development and familiar with statistical analysis, analytical method troubleshooting, and analysis of product quality attributes related to biological processing.
Strong oral and verbal communication skills, interact effectively with diverse internal and external partners, and the ability to provide cross-functional leadership and mentorship.
Excellent technical writing skills and attention to details in technical reports and documents.
A self-starter and excellent teammate with strong leadership and decision-making skills, who can provide mentorship to junior staff.
Someone who strongly values working on and leading teams.
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 now for 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.