This position is located in San Diego California. You must be open to relocation to San Diego if you are interested in this role!
Seeking an experienced analytical chemist to join our AD/QC group at the Sr. Scientist or 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.
PRIMARY 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 oligonucleotide 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 5 years (Sr. Research Associate) or 10 years (Assistant Director) of industry experience in Analytical Chemistry or related discipline
- Ph.D. with at least 2 years (Sr. Scientist) or 7 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
- Good written and verbal communication skills