Sr Principal Chemist- Product Protection

About the role

The Sr. Principal Chemist will conduct non-routine analyses of drug substances, drug products, and other non-typical samples suspected to involve counterfeiting, tampering, or diversion using a variety of analytical techniques/instrumentation. They will also develop advanced authentication strategies/analytical techniques for pipeline assets.

Responsibilities

• Perform analyses of suspect products using LC-MS (including intact mass and peptide mapping), HPLC, UPLC, spectroscopy and other analytical techniques.
• Analyze LC-MS data and perform limited structure elucidation on both small and large molecules.
• Provide non-laboratory support for other product authentication processes (e.g., packaging authentication, packaging variable data verification, etc.).
• Collaborate with AQCO colleagues and other analytical SMEs to solve complex sample analyses.
• Develop and validate robust scientifically advanced methods with the required performance attributes to satisfy stakeholder needs.
• Troubleshoot issues with methods and/or equipment.
• Execute testing protocols in accordance with local procedure and regulatory requirements.
• As required, provide training or mentorship to other AQCO colleagues or cross-functional team members.

Requirements

• Deep technical expertise in separation sciences, spectroscopy, hyphenated mass spectrometry techniques (MS and MSn.) and their application.
• Demonstrated proficiency in the use of multiple instrument platforms (Thermo, Agilent, Waters etc.) and associated software platforms (Chromeleon, Excalibur, Biopharma Finder, Genedata, etc.).
• Ability to handle controlled substances.
• Ability to work with non-technical personnel.
• Ability to manage/communicate confidential information.
• Strong technical problem-solving ability both independently and as part of a team.
• Motivated to work independently to produce high quality work product in an efficient manner.
• High attention to detail in all aspects of the work.