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ASSISTANT DIRECTOR-ANALYTICAL DEVELOPMENT & QUALITY CONTROL

Seeking an experienced analytical chemist to join our QC & Analytical Development group at the Assistant Director level. The ideal candidate will be a self-starter, familiar with a broad range of analytical techniques, possess a strong work ethic, have good 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:

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

REQUIREMENTS:

• BS or MS with at least 10 years of industry experience in Analytical Chemistry or related discipline
• Ph.D. with at least 7 years 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
• Good written and verbal communication skills