Lead Analytical Scientist

2 weeks ago

Flowood, Mississippi, United States Amgen Full time

Position Overview

As a Lead Analytical Scientist at Amgen, you will play a pivotal role in advancing our mission to serve patients by utilizing your expertise in analytical chemistry. This position involves collaborating with a dedicated team of scientists and analysts to develop and refine analytical methodologies that are essential for the characterization of late-phase synthetic small molecules, synthetic peptides, and siRNA programs.

Key Responsibilities

  • Develop and implement analytical control strategies for late-phase clinical programs.
  • Optimize and validate analytical methods for testing and characterization of synthetic small molecules and peptides.
  • Work closely with drug substance and drug product development teams to meet project goals.
  • Provide critical analytical data to support drug development processes, including purity analysis and structure elucidation through mass spectrometry.
  • Lead and coordinate activities at contract manufacturing and testing facilities.
  • Oversee method transfers to contract manufacturing organizations (CMOs) or testing laboratories.
  • Review and approve protocols and reports from CMOs and contract testing labs.
  • Assist project leads in authoring technical reports and regulatory documentation.
  • Mentor junior scientists and foster a collaborative team environment.

Qualifications

We are seeking a dynamic scientist with the following qualifications:

  • A Bachelor’s degree with 5 years of relevant scientific experience, a Master’s degree with 3 years of experience, or a Doctorate degree (PhD, PharmD, or MD) with applicable post-doctoral experience.
  • Preferred: PhD in Analytical Chemistry or Biochemistry with a focus on mass spectrometry.
  • At least 2 years of post-PhD experience in the pharmaceutical or biotechnology sector, emphasizing process and product development.
  • In-depth knowledge of small molecule analysis and organic chemistry.
  • Hands-on experience in method development, validation, and transfer for in-process, release, and stability testing.
  • Familiarity with analytical techniques such as MS, UV, NMR, and FTIR.
  • Strong communication skills and the ability to lead cross-functional teams effectively.
  • Excellent technical writing skills, with attention to detail in regulatory documentation.

What We Offer

At Amgen, we are committed to the professional growth and well-being of our employees. We provide a comprehensive benefits package that includes:

  • Health and welfare plans, including medical, dental, and vision coverage.
  • A Retirement and Savings Plan with generous company contributions.
  • Flexible work arrangements, including options for remote work.
  • Opportunities for career development and advancement.

Join us in our mission to unlock the potential of biology for patients with serious illnesses.

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