Description

Amgen is currently seeking a Sr. Scientist – Analytical Chemist in our Pivotal Attribute Sciences Department in Thousand Oaks, CA. This team plays a crucial role in pivotal phase analytical development, including method development, validation, transfer, process and product development support, and GMP testing of drug substances and drug products. 

The Scientist will work closely with a team of analysts and scientists responsible for the technical aspects of developing analytical tools to gain understanding of key quality attributes in product and process for late phase synthetic small molecule, synthetic peptide, and/or siRNA programs. The Scientist will integrate and optimally utilize

platform and in-depth product attribute knowledge to advance Amgen products and ensure success through pivotal clinical phases to marketing authorization application.

Key Responsibilities:

• Define analytical control strategies and implement methodologies for development of late phase clinical programs. 
• Develop, optimize, and authorize analytical methods for synthetic small molecules, and/or synthetic peptide testing and characterization.
• Collaborate closely with drug substance and drug product process development colleagues to achieve project objectives.
• Provide analytical data to support drug substance and drug product development, including purity analysis, chiral purity and structure elucidation using mass spectrometry.
• Lead activities at contract manufacturing and testing sites.
• May lead method transfer to CMO or contract testing labs.
• Review and approve protocols, reports from CMO and contract testing labs.
• Support project team lead to author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents.
• May lead and mentor a small group of scientists.

Requirements

Basic Qualifications:

• Advanced and proficient understanding and use of technical principles, theories, and concepts to perform an expansive range of work in a role.
• Doctorate degree or Doctorate degree completed by May 2024

OR

• Master’s degree and 3+ years of scientific experience

OR

• Bachelor’s degree and 5+ years of scientific experience

Preferred Qualifications:

• PhD in Analytical Chemistry, Biochemistry with emphasis in mass spectrometry
• 2+ year’s post-PhD experience in the pharmaceutical or biotech industry, focusing on process and product development, and analytical method development for drug substances and products.
• Strong understanding of small molecule analysis and structure elucidation informed by knowledge of organic chemistry.
• Hands on experience in method development, validation, and transfer for in-process, release, and stability testing
• Experience in peptide method development, characterization, and analytical control strategy, especially having mass spectroscopy (MS) experience.
• Proficiency in a broad spectrum of structure elucidation and physicochemical techniques including MS, UV, NMR, FTIR, etc.
• Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.
• Excellent communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile
• Ability to work effectively in cross-functional teams, and across various geographic locations in different time zones.
• Excellent technical writing skills with attention to detail in authoring methods, specifications, technical reports, and regulatory filing documents