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