Process Development Senior Scientist

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.

Salary Range
125,274.00 USD - 143,832.00 USD