Senior Research Associate / Assistant Director, ADQC

Role Summary

Seeking an experienced analytical chemist to join our Analytical Development & Quality Control (ADQC) group at the Sr. Research Associate, Senior Scientist or Assistant Director level (depending on experience). The ideal candidate will be familiar with a broad range of analytical chemistry techniques, possess a strong work ethic and strong technical background, demonstrate excellent oral and written communication skills, and have experience working in a GMP environment. The successful candidate will be able to perform the following responsibilities with a high degree of independence and attention to detail.

Responsibilities

• Manage the analytical activities for oligonucleotide therapeutic development projects
• Coordinate and execute testing of drug substance intermediate, drug substance, and drug product samples for release and stability studies
• Manage outsourced analytical activities at external contract labs
• Conduct analytical investigations
• Develop and optimize analytical methods
• Develop drug substance specifications ensuring efficient integration across Chemistry, Manufacturing, and Controls (CMC) and other relevant disciplines such as Clinical and Toxicology
• Design and execute method validation and method transfer protocols
• Author scientific reports and portions of the CMC section of regulatory filings
• Present at internal and cross-functional scientific meetings

Qualifications

• BS or MS with at least 5 years (Sr. Research Associate) or 8 years (Assistant Director) of industry experience in Analytical Chemistry or related discipline
• Ph.D. with at least 2 years (Sr. Scientist) or 8 years (Assistant Director) of industry experience in Analytical Chemistry or a related discipline
• Skilled in operating LC-MS, HPLC, and GC for the analysis of drug substance and drug product samples
• Good understanding of the drug development process
• Practical knowledge of GMP requirements, with hands-on GMP experience preferred
• Good understanding of ICH and FDA method validation guidelines, including phase-appropriate strategies
• Ability to problem solve, manage priorities and maintain aggressive timelines for multiple projects
• Ability to work productively and independently within a team or matrix environment
• Excellent written and verbal communication skills