Description

Amgen is currently seeking a Principal 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:

• Lead and mentor a group of analysts in supporting process development.  Provide career development guidance to the team members.
• Lead analytical method development 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.
• Define analytical control strategies and implement methodologies for development of late phase clinical programs. 
• Provide concise summary to cross-functional leadership for endorsement of key decisions.
• Oversee activities at contract manufacturing and testing sites.
• Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Address analytical and product quality inquiries from health authorities.

Requirements

Basic Qualifications:

• Advanced knowledge of leading and/or state of the art principles and theories in discipline and basic knowledge of related and adjacent disciplinary areas.
• Doctorate degree and 2+ years of scientific experience

        OR

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

        OR

• Bachelor’s degree and 7+ years of scientific experience

Preferred Qualifications:

• PhD in Analytical Chemistry, Biochemistry with emphasis in mass spectrometry
• 3+ years’ experience in the pharmaceutical or biotech industry, focusing on process and product development, and analytical method development for peptide drug substances and products.
• 2+ years’ experience as a people manager
• 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.
• Experience in method development and characterization related to innovative peptide synthesis is a plus.
• 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.
• Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage deliverables against timelines.
• Excellent communication skills and ability to provide concise summary to 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