Scientist/Senior Scientist, Analytical Development and Quality Control

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

The Role

We are seeking a talented, collaborative, and highly motivated individual with expertise analytical methods highly focused on HPLC and QC operations to join our core team of scientists and engineers. The Senior Scientist will execute Quality Control testing, and associated operations and contribute to analytical testing to ensure compliance with cGMP requirements. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market.

Key Responsibilities

• Lead the design, development, optimization, and execution of HPLC-based analytical methods (e.g., RP-HPLC, SEC, IEX) to support in-process, release, and stability testing.
• Develop, qualify, validate, and characterize GMP-compliant purity, SEC, and content methods for intermediates and drug products, with a strong emphasis on chromatographic workflows.
• Author and execute cGMP method qualification and validation protocols, prepare reports, and perform/oversee routine QC testing.
• Serve as Subject Matter Expert for chromatography methods during investigations of deviations, OOS/OOT events, assay failures, and other non-conformance issues.
• Provide technical leadership in HPLC troubleshooting, instrument maintenance coordination, data integrity practices, and chromatographic data review.
• Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions.
• Maintain rigorous laboratory documentation and complete, audit-ready analytical records.
• Collaborate effectively with QC, Manufacturing, Process Development, and Regulatory teams to enable program success across phases.
• Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills.

Qualifications

• Ph.D. in Analytical Chemistry, Biochemistry, or related field with a minimum of 4 years (10 years for Senior Scientist) in the biotech/pharmaceutical industry; or M.S. with commensurate experience.
• Demonstrated in-depth expertise in HPLC, including method development, troubleshooting, system suitability design, chromatographic theory, and data interpretation.
• Hands-on experience with multiple chromatographic techniques (RP-HPLC, SEC, IEX, affinity, gradient optimization, detector setup/maintenance).
• Proven success developing and validating GMP analytical methods and supporting GMP operations.
• Experience with complementary analytical techniques such as UV-Vis, LC-MS, CE, ELISA, or other functional assays is beneficial.
• Experience working in a QC or cGMP laboratory environment with strong understanding of data integrity requirements (ALCOA ).
• Strong organizational skills, precision in documentation, and ability to manage multiple analytical workflows simultaneously.
• Excellent oral and written communication skills.
• Commitment to collaborative work within interdisciplinary project teams.

At Vaxess, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to careers@vaxess.com.