Sr. Scientist-ANALYTICAL DEVELOPMENT & QUALITY CONTROL
Seeking an experienced analytical chemist to join our QC & Analytical Development group at the Sr. Scientist 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:
- 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